Regulatory Framework For Drug Approvals V 5

Regulatory
Framework for
Drug Approvals
Version 5.0
Mar 2014
This page is left blank intentionally
Mar 2014
Saudi Food & Drug Authority 2
Regulatory Framework for Drug Approvals
Version 5.0
Drug Sector
Saudi Food & Drug Authority
Kingdom of Saudi Arabia
Please visit SFDA’s website at http://www.sfda.gov.sa/en/drug for the latest update
Mar 2014
Drug Sector
Vision & Mission
Vision
To be the leading regional Drug Regulatory Authority for pharmaceuticals and safety of
cosmetic products, with professional excellence and services that contribute to the
protection and advancement of public health in the Kingdom of Saudi Arabia.
 ‫א‬
،‫א‬‫א‬‫א‬‫א‬‫א‬‫א‬‫א‬‫א‬
  K‫א‬‫א‬‫א‬‫א‬
Mission
Protecting public health by ensuring safety, quality, efficacy and accessibility of human,
veterinary drugs and biological products, and safety of cosmetics, through administration of
a national regulatory system which is consistent with international best practice. Through
our mission, we also provide accurate and scientific‐based information to the public and
healthcare professionals.
 ‫א‬
‫א‬ ‫א‬ ‫א‬ ‫א‬ ‫א‬        ‫א‬ ‫א‬ 
‫א‬‫א‬‫א‬‫א‬‫א‬‫א‬‫א‬‫א‬
 .‫א‬‫א‬‫א‬
Mar 2014
Document Control
Version Date Author(s) Comments

1.0 15/03/2008 Licensing department Initial draft for internal
consultation
1.1 24/03/2008 Licensing department Draft revision (old name v1)
2.0 15/07/2008 Licensing department Published for comments (old
name v7)
2.1 23/11/2008 Licensing department Internal consultation revision (old
name v7-22-23)
2.2 27/12/2008 Licensing department External consultation revision (old
name v8)
3.0 19/01/2009 Licensing department Posted revision (old name final)
3.1 15/02/2009 Licensing department Internal consultation revision (old
name final 1)
3.2 10/05/2009 Licensing department Revisions after management
discussion
4.0 05/07/2009 Licensing department Final version posted
4.1 22/08/2013 Regulatory Affairs 1st Internal revision
4.2 21/10/2013 Regulatory Affairs 2nd Internal revision
4.3 17/11/2013 Regulatory Affairs Final revision
5.0 16/03/2014 Regulatory Affairs Final version posted
Mar 2014
Table of Contents
DOCUMENT CONTROL ..................................................................................................................... 5

TABLE OF CONTENTS ....................................................................................................................... 6
TABLE OF FIGURES ........................................................................................................................... 6
FOREWORD .......................................................................................................................................... 7
GLOSSARY ............................................................................................................................................ 8
REGISTRATION RULES ................................................................................................................... 11
SUBMISSION PROCESS.................................................................................................................... 12
STEP BY STEP PROCEDURE: ................................................................................................................. 12
MARKETING AUTHORIZATION APPLICATION (MAA) ......................................................... 15
RENEWAL OF MARKETING AUTHORIZATION ....................................................................... 19
VARIATION ......................................................................................................................................... 22
APPENDICES ...................................................................................................................................... 26
APPENDIX A: PERFORMANCE TARGETS .............................................................................................. 27
APPENDIX B: ACRONYMS AND ABBREVIATIONS ................................................................................. 28
APPENDIX C: APPLICATION FORMS..................................................................................................... 29
Table of Figures
Figure 1 Flow chart of the submission process .................................................................................. 14
Figure 2: Schematic figure showing the different levels for getting a marketing authorization for
Generics, NCE, Biologicals, Radiopharmaceuticals, Veterinary, Herbal and Health products
....................................................................................................................................................... 18
Figure 3: Schematic figure showing the renewal process of a marketing authorization ................ 21
Figure 4: Schematic figure showing the workflow of Variation ....................................................... 25
Mar 2014
Foreword
The Drug Sector in the Saudi Food & Drug Authority (SFDA) has developed this
document, ‘Regulatory Framework for Drug Approvals’, to provide assistance for
stakeholders on how to submit applications for various types of drug products. This
document is an administrative instrument that outlines the requirements of various
types of applications to be filled out and submitted to the SFDA.
Besides the Market Authorization Application (MAA) of various types of drug

products, it also describes the renewal of MAA and variations applications. Various
application forms and procedures for processing applications to marketing the product
in Saudi Arabia are also included in this document.
It is important to note that the SFDA reserves the right to request information,
material or defined conditions not specifically described in this document, in order to
allow the administration to adequately assess the safety, efficacy and quality of drug
products. The SFDA is committed to ensuring that such requests are justifiable and
decisions are clearly documented.
This document should be read in conjunction with the other relevant and
applicable guidance documents. A copy of this document can be found on our
website:
http://www.sfda.gov.sa/en/drug/drug_reg/Pages/drug_reg.aspx
The SFDA is fully committed to an orderly process for the review and
authorization of pharmaceutical products, and we are working to develop procedures
to implement those aspects of the initiative. We are also committed to assuring that
stakeholders remain fully informed of our progress as we implement the initiative.
Mar 2014
Glossary
Applicant The company or its representative.

Biologicals Biological products include a wide range of products such
as vaccines, blood and blood components, allergenics,
somatic cells, gene therapy, tissues, and recombinant
therapeutic proteins. Biologics can be composed of sugars,
proteins, or nucleic acids or complex combinations of
these substances, or may be living entities such as cells
and tissues. Biologics are isolated from a variety of natural
sources — human, animal, or microorganism — and may
be produced by biotechnology methods and other cutting-
edge technologies1.
Biosimilars Therapeutic proteins produced by recombinant DNA
technology or gene expression method following the
footsteps of one licensed reference biotechnological
product after the expiration of the innovator’s patent. They
are complex and heterogeneous in their nature; hence they
are not considered generics, but as closely similar to the
innovator’s drug as possible.
Common Technical An international harmonized format for submissions for
Document (CTD) approval of pharmaceuticals for human use. The CTD
provides a standardization of the presentation of the
content.
Dosage form The finished formulation of a pharmaceutical product, e.g.
tablet, capsule, suspension, solution for injection,
suppository
Drug An article intended for use in the diagnosis, cure
mitigation, treatment, or prevention of disease and which
is intended to affect the structure or function of the body.
Drug Application A drug application includes the application form, the product
file and the drug samples
Generic (multisource) Approved drugs that are no longer protected by patents
drug and are approved for marketing by companies without the
need for clinical trials; generic drugs are bioequivalent to
the original approved drugs.
Hard copy - product The paper-based submission of the product file.
file
1
FDA (Drugs@FDA Glossary of Terms)
Mar 2014
Herbal product Any finished labeled medicinal products that contain as
active ingredients aerial or underground parts of plants or
other plant materials or the combination of them, whether
in crude state or plant preparation that is used to treat or
prevent diseases or ailments or to promote health and
healing. Plant materials include juices, gums, fatty oils
and any other substance of this nature.
Innovator Generally, the innovator pharmaceutical product is that
pharmaceutical which was first authorized for marketing, on the basis of
product documentation of quality, safety and efficacy.
Inquiry Form A form used to collect needed information by the

applicant.
Known active A new dosage form, strength, or indication for a new drug
substance already marketed in Saudi Arabia.
New Drug/ New A drug molecule that has never been marketed in Saudi
Chemical Entity Arabia.
Product manager The SFDA employee responsible for following up all
activities related to drug approval process.
Radiopharmaceutical A radioactive drug that can be administered safely to
product humans for diagnostic and therapeutic purposes.
Reference number Any combination of letters and numbers that is assigned to
the transaction in order to follow it.
Renewal of marketing A process of renewing the marketing authorization license
authorization every five years.
SADAD A system that links between the commercial sector and the
local banks; it offers the ability to collect its customer
payment electronically through all the banking channels in
KSA around the clock.
SFDA's pricing rules The pricing guideline “The Rules for Pharmaceutical
Products Pricing” which include the general requirements
and criteria for pricing a pharmaceutical product and
constitute the general framework of the “Pharmaceutical
Products Pricing Committee” to suggest the price.
Soft copy – product file The electronic version of the product file presented in CDs
or DVDs.
Stringent Drug An SRA is one the following authorities: US FDA, EMA,
Regulatory Authority MHRA, SwissMedic, Health Canada and TGA.
(SRA)
Mar 2014
Vaccines Preparations that contain antigenic substances capable of
inducing a specific and active immunity against the
infecting agent or the toxin or the antigen produced by it.
Validation (Phase I & The process of checking if documents satisfy a certain

II) criterion.
Variation A process of informing the authority of any minor or
major changes in the drug product.
Veterinary drug Any substance or mixture of substances manufactured,
sold or represented for use in:
 the diagnosis, treatment, mitigation or prevention
of a disease, disorder, abnormal physical state, or
its symptoms, in animals,
 restoring, correcting or modifying organic
functions in animals
Mar 2014
Registration Rules
Drug sector at SFDA sets the rules for registering different types of drugs.
Such rules are developed by examining the current and future competencies of its
evaluators. These rules will help the applicants to decide whether to submit their drug
applications or not.
The following rules/conditions if met, the submitted drug application will be

accepted:
1. New Drug and Biological (either registered in an SRA or not).
2. Generic Drug that is equivalent to the registered innovator in an SRA (the

drug shall be registered as “New Drug” because the API is not registered
in KSA).
3. Biosimilar drug only if it is manufactured locally.
4. Biosimilar drug if registered in an SRA.
5. Combination products (2 or more API):
a. If the API's are registered in KSA as single drugs (with the same
strength, dosage form and therapeutic indication); then the
application is considered Generic.
b. If one or more of the API's are not registered in KSA, or registered

with different strength, dosage form or indication; then the
application is considered New Drug.
Notes:
 Performance targets will differ depending on the type of drug.
 Generic drugs that are not equivalent to the innovated product in the strength, are
considered Generic (as long as the API is registered in KSA).
 Generic drugs that are not equivalent to the innovated product in the dosage form,
are considered New Drug – Known active substance (as long as the API is
registered in KSA).
Mar 2014
Submission Process
The process of submitting a NEW drug application2 to the SFDA consists of

three major steps:
1. Online submission of the APPLICATION FORM,
2. The PRODUCT FILE delivered in person,
3. DRUG SAMPLES.
Important Note:
 All days mentioned throughout this document are WORKING days (subject to
change).
Step by step procedure:
1. Applicant shall go to the Saudi Drug Registration system (SDR) website

(http://sdr.sfda.gov.sa/)
2. Login to apply (each applicant should have a user ID and a password3)
3. Choose and complete the appropriate application form:
 The application form can be saved partially as the applicant may complete
it in several steps.
4. Then, the applicant has to pay the submission fee (through SADAD Payment
System) in order to submit the application form and schedule an appointment
to deliver the hard and soft copy of the product file:
 Submission fees are mandatory in order to proceed to the next step.
 The applicant can reschedule 3 weeks before the appointment. An

automatic reminder will be sent 3 days before the appointment.
 A reference number will be generated, and this number should always be

used with regard to any communication with the SFDA.
2
A drug application includes the application form, the product file and the drug samples.
3
The Drug Establishment National Registry (DENR) is the source of the user ID and password
Mar 2014
5. At the appointment, the applicant will deliver the product file along with the
samples.
6. The Regulatory Affairs Pharmacist will validate (Phase I) the following:
a. The application form
b. The product file (hard and soft copy)
c. The samples
 If the above are valid, an acknowledgment letter will be generated and

given to the applicant. The drug application will enter the queue.
 If some of the above are missing or not satisfactory, an acknowledgment

letter will be generated and given to the applicant stating the deficiencies.
The applicant will have a period of 90 days to complete the requirements
and the drug application will not be queued. When the required
information is met, an appointment (completion appointment) is requested
by email ([email protected]), and the step no 6 will be repeated again.
Notes:
 Currently for renewal applications, no appointment scheduling is required.

And for the variation applications, neither payment nor appointment are
required.
 Refer to the Guidance for Submission for more details on preparing the drug
file.
Mar 2014
Figure 1 Flow chart of the submission process
Mar 2014
Marketing Authorization Application (MAA)
The Market Authorization Application for the different drug submission types will be
subjected to the following processes:
A. Validation (Phase II):

1. The product file will be validated to ensure that all information provided are
according to the requirements and/or guidelines:
a. The completed file will proceed to the next steps in parallel –
assessment, testing and inspection.
b. If any information is missing or incorrect, the applicant will be notified
electronically. The applicant will be given an opportunity to complete
the file within 90 days. Otherwise, the file will be rejected.
2. Performance target: 10 days for all drug submission types
B. Assessment:
1. The product file will be distributed by the product manager to THREE groups:
Quality, Safety and Efficacy.
2. Quality assessment will be performed by a quality group. Once completed, a
report will be forwarded to the product manager.
3. Safety assessment will be performed by a safety group. Once completed, a
4. Efficacy assessment will be performed by an efficacy group. Once completed,
a report will be forwarded to the product manager.
5. If a clarification is required, an electronic “Inquiry Form” will be forwarded
to the applicant through the product manager. The response should be received
within 90 days. Otherwise, the application will be rejected.
6. The reports (i.e. recommendation for approval or rejection) will be forwarded
to the secretary of the Registration Committee.
7. Performance target:
a) Generics: 120 days
b) New Drugs:
i. Registered in a Stringent Regulatory Authority (SRA): 245 days
ii. Not registered in SRA: 370 days
c) Biologicals:
i. Registered in SRA: 245 days
d) Radiopharmaceuticals: 245 days
e) Veterinary drugs: 150 days
f) Herbal & Health products: 110 days
Mar 2014
C. Testing
1. Samples received by SFDA headquarters will be sent to the laboratory.
2. If more information, clarification or additional samples are needed, an
electronic “Inquiry Form” will be forwarded to the applicant through the
product manager. A response should be received within 90 days.
3. The results will be written in a report and forwarded to the product manager.
4. Performance target: 90 days for all drug submission types
Note:
 Testing will not delay the registration of a product
 The 1st batch imported after approval will be tested and the company
will be notified of the results within 35 days. However, the company
should not distribute the product during this period. After 35 days, the
company may distribute the product under their own liability.
D. Inspection
1. The product file will be forwarded to the Head of the inspection unit:
a. If more information or clarification is required, an electronic “Inquiry
Form” is forwarded to the applicant through the Inspection unit. A
response should be received within 90 days.
2. Inspection department will check the manufacturing line:
a. If the manufacturing line has been approved (valid certificate from
KSA MoH, SFDA or GCC-DR), the line would not be inspected and
the head of the inspection unit will inform the product manager.
b. If the manufacturing line is not approved:
i. The head of the inspection unit will schedule a visit for
inspection (depending on the time available for both inspectors
and the company).
ii. After the visit, the inspection report will be written and
forwarded to the Head of inspection unit.
iii. Head of inspection unit will send the inspection report to the
company (please, refer to the Inspection guidance).
3. The final inspection report will be forwarded to the product manager.
b) New Drugs: 245 days
c) Biologicals: 245 days
After the Assessment and Inspection reports are completed, the product file will
be forwarded to the pricing department.
Mar 2014
E. Pricing
1. The Pricing department handles pricing requests and ensures that all pricing
requirements are met (such as the presence of a valid, updated and
authenticated Price Certificate (Form-30) and a product sample in its final
pack form). However, if more information or clarification is required, an
2. The Pricing department will calculate the price of each concentration and/or
pack size of different product from a pricing & economic perspectives
according to the SFDA's pricing rules.
3. The Pricing minutes is then prepared to be discussed with the Pricing
Committee.
4. If the committee ask for more information or clarification, an electronic
“Inquiry Form” will be forwarded to the applicant by the pricing department
through the product manager. A response should be received within 90 days.
5. The approved price by the committee will be written in a report and forwarded
to the product manager.
6. Performance target: 20 days for all drug submission types4
F. Product Licensing
1. Product manager will receive all reports from departments and forward them
to the secretary of the “Registration Committee”:
a. The secretary of the Registration Committee will add the product to the
agenda of the next available meeting.
b. At the meeting, the Registration Committee will either recommend
approval, rejection or ask for further information – if needed.
c. Performance target: 12 days for all drug submission types
2. The meeting minutes:

a. Will be sent to the SFDA CEO for approval.
b. Then, the Product Licensing department will issue a marketing
authorization.
c. Performance target: 3 days for all drug submission types
Total performance target =

b) New Drugs:
i. Registered in a Stringent Regulatory Authority (SRA): 290 days
4
Only for the drug types that require pricing
Mar 2014
c) Biologicals:
i. Registered in SRA: 290 days
Note: the performance target in any step will STOP if a clarification or information is
needed from the applicant, and resume after receiving the response.
Appeal Process:
The applicant has the right to appeal against the decision within 60 calendar days by
submitting a letter including the scientific justifications supporting the appeal, in
addition to fee payment (through SADAD Payment System). However, The Pricing
Committee may negotiate the approved price with the company – if needed and upon
the request of the applicant.
Figure 2: Schematic figure showing the different levels for getting a marketing authorization for
Generics, NCE, Biologicals, Radiopharmaceuticals, Veterinary, Herbal and Health products
Mar 2014
Renewal of Marketing Authorization
Notes:
 The renewal of marketing authorization should be carried out every 5 years.
 The renewal application should be requested 6 months before the expiry date of
the registration certificate.
 For the renewal requirement, guidelines are published in the SFDA website.
The Renewal of Marketing Authorization will be subjected to the following processes:

1. The product file will be validated to ensure that all information provided are
a. The completed file will proceed to the next steps.
the file within 90 days. If no response, the file will be rejected.
2. Performance target: 10 days.
B. Assessment:
1. The product file will be distributed by the product manager to THREE groups:
Quality, Safety and Efficacy.
4. Efficacy assessment will be performed by a efficacy group. Once completed,
5. If a clarification of any group is required, an electronic “Inquiry Form” will
be forwarded to the applicant through the product manager. The response
should be received within 90 days. Otherwise, the application will be rejected.
6. The reports (i.e. recommendation for approval or rejection) will be forwarded
to the Director of the Product Licensing department.
C. Pricing:
1. The Pricing department will review the price according to the SFDA's pricing
rules. However, if more information or clarification is required, an electronic
“Inquiry Form” will be forwarded to the applicant through the product
manager. A response should be received within 90 days.
Mar 2014
2. The Pricing minutes is then prepared to be discussed with the Pricing
Committee.
3. If the committee ask for more information or clarification, an electronic
“Inquiry Form” will be forwarded to the applicant by the pricing department
through the product manager. A response should be received within 90 days.
4. The final price approved by the committee will be written in a report and
forwarded to the product manager.
D. Inspection:
1. Inspection department will check if the manufacturing line is approved before
or not:
a. If the manufacturing line is approved with a valid inspection report, the
line would not be inspected and the head of the inspection unit will
inform the product manager. However, if more information or
clarification is required, an electronic “Inquiry Form” is forwarded to
the applicant through the Inspection unit. A response should be
received within 90 days.
b. If the manufacturing line is not approved:
i. The head of the inspection unit will schedule a visit for
and the company). Then inform the product manager to
continue the process.
ii. After the visit, the inspection report will be written and
iii. Head of inspection unit will send the inspection report to the
company.
E. Marketing Authorization Renewal:

1. The product manager will forward the renewal application to the secretary of
the “Renewal Committee”.
2. The Committee will either recommend approval, rejection or ask for further
information if needed.
3. The meeting minutes will be sent to the Drug VP for approval.
4. The licensing department will issue the renewal authorization documents.
Total performance target = 70 days
needed from the applicant, and resume after receiving the response.
Mar 2014
Appeal Process:
The applicant has the right to appeal within 60 calendar days of the SFDA’s final
decision. Please, refer to the relevant guideline.
Figure 3: Schematic figure showing the renewal process of a marketing authorization
Mar 2014
Variation
The variation or post-marketing changes can be classified into two categories:

A. Minor changes:
1. Type IA: minor variations that does not require prior approval before
implementation (“Do and Tell” procedure) but require notification
submitted by the marketing authorization holder (MAH) within 60 days
after implementation.
2. Type IB: minor variations that must be notified to the SFDA by the
Marketing Authorization Holder (MAH) before implementation, but do not
require a formal approval. However, the MAH must wait a period of 120
days to ensure that the application is deemed acceptable by the SFDA
before implementing the change (“Tell, Wait and Do” procedure).
B. Major variation:
3. Type II: major variations in which there might be a significant impact on
the Quality, Safety or Efficacy of a medicinal product and require prior
approval before implementation.
The variation will be subjected to the following processes:

1. The variation file will be validated to ensure that all information provided are
a. The completed file will proceed to the next steps.
the file within 90 days. Otherwise, the file will be rejected.
Depending on the type of variation, one or more department may review the
variation application (refer to the latest published guideline).
B. Product Licensing:
1. The variation request will be evaluated/reviewed.
2. The necessary action will be taken within the department.
within 90 days.
Mar 2014
C. Assessment:
1. The product file will be distributed to THREE groups: quality, safety and
efficacy – as needed.
4. Efficacy assessment will be performed by an efficacy group. Once completed,
within 90 days. Otherwise, the application will be rejected.
6. The reports (i.e. recommendation for approval or rejection) will be collected
by the product manager.
7. The reports will either be forwarded to other department(s) or registration
committee depending on the type of variation.
8. Performance target for:
 Type IA: 45 days
 Type IB: 105 days
 Type II: 120 days
D. Testing:
1. Samples received by SFDA headquarters will be sent to the laboratory.
2. If more information, clarification or additional samples are needed, an
electronic “Inquiry Form” is forwarded to the applicant through the product
manager, and a response should be received within 90 days.
3. The results will be written in a report and forwarded to the product manager.
E. Inspection:
1. Inspection department will review the variation request in addition to the
assessment reports – if applicable:
a. If the manufacturing line is approved with a valid inspection report, the
line would not be inspected and the head of the inspection unit will
inform the product manager.
c. If the manufacturing line is not approved:
iv. The head of the inspection unit will schedule a visit for
and the company). Then inform the product manager to
continue the process.
v. After the visit, the inspection report will be written and
Mar 2014
vi. Head of inspection unit will send the inspection report to the
company.
 Type IA: 45 days
 Type IB: 105 days
 Type II: 120 days
F. Pricing:
1. The Pricing department handles all variation requests that require pricing
review (according to the guideline) and ensures that all pricing requirements
are met. However, if more information or clarification is required, an
2. The Pricing department will re-calculate the price of each concentration and/or
pack size of different product according to the SFDA's pricing rules.
3. The Pricing minute is then prepared to be discussed with the Pricing
Committee.
4. If the Pricing Committee asks for more information or clarification, an
electronic “Inquiry Form” will be forwarded to the applicant by the pricing
department through the product manager. A response should be received
within 90 days.
5. The new approved price by the committee will be written in a report and
forwarded to the product manager
G. Variation Approval:
1. For type IA:
a. The Licensing Director will approve the final report.
b. Notify the applicant.
c. Performance target: 5 days.
2. For type IB:

a. The Licensing Director will approve the final report.
b. Notify the applicant.
c. Performance target: 5 days.
3. For type II:

1. Product manager will receive all reports from departments and hand
them to the secretary of the “Registration Committee”:
a. The secretary of the Registration Committee will add the product to
the agenda of the next available meeting.
Mar 2014
b. At the meeting, the Registration Committee will either recommend
approval, rejection or ask for further information – if needed.
c. Performance target: 12 days
2. The meeting minutes:

a. Will be sent to the SFDA CEO for approval.
b. Then, the Product Licensing department will issue a marketing
authorization.
c. Performance target: 3 days
Total performance target (Type IA) = 60 days

Total performance target (Type IB) = 120 days
Total performance target (Type II) = 145 days
needed from the company, and will be resumed after receiving the response.
Appeal Process:
The applicant has the right to appeal within 60 calendar days of the SFDA’s final
decision. Please, refer to the relevant guideline.
Figure 4: Schematic figure showing the workflow of Variation
Mar 2014
Appendices
Mar 2014
Appendix A: Performance Targets
Process Total Performance Target5
Marketing Authorization Application for Generics 165 days
Marketing Authorization Application for New Drugs 290 days
Marketing Authorization Application for New Drugs

415 days
not registered in an SRA
Marketing Authorization Application for Biologicals 290 days
Marketing Authorization Application for Biologicals

415 days
not registered in an SRA
Marketing Authorization Application for

290 days
Radiopharmaceuticals
Marketing Authorization Application for Veterinary

175 days
drugs
Marketing Authorization Application for Herbal &

155 days
Health products
Renewal of Marketing Authorization 70 days
Variation to a Marketing Authorization Type IA 60 days
Variation to a Marketing Authorization Type IB 120 days
Variation to a Marketing Authorization Type II 145 days
5
Working days
Mar 2014
Appendix B: Acronyms and abbreviations
API Active Pharmaceutical Ingredients
ATC Anatomical Therapeutic Chemical Classification System
Anatomical Therapeutic Chemical Classification System for veterinary

ATCvet
products
BSE Bovine spongiform encephalopathy
COO Country of Origin
CPP Certificate of Pharmaceutical Product
CTD Common Technical Document
Drug VP SFDA’s Drug Vice President
EMA European Medicines Agency
GCC-DR Gulf Cooperation Council Drug Registration
HATC Herbal Anatomical Therapeutic Chemical Classification System
KSA Kingdom of Saudi Arabia
MA Marketing Authorization
MAA Marketing Authorization Application
MHRA Medicines and Healthcare products Regulatory Agency
NCE New Chemical Entity
SDR Saudi Drug Registration system
SFDA Saudi Food and Drug Authority
SMF Site Master File
SPC Summary of Product Characteristics
Swissmedic Swiss Agency for Therapeutic Products
TGA Therapeutic Goods Administration
TSE Transmissible Spongiform Encephalopathy
US FDA United States of America Food and Drug Administration
Mar 2014
Appendix C: Application Forms
Application form Page
Marketing Authorization Application of Medicinal Product for Human 30

Use: New Drugs, Generics (Multisource), Biologicals and
Marketing Authorization Application of Medicinal Product for 46

Veterinary Use
Marketing Authorization Application of Herbal Product 61
Application for Variation to a Marketing Authorization 74
Note:
 The application forms are available electronically in SDR system. These forms
are only for viewing and preparing the required information before starting
the process of submission.
Mar 2014
 ‫א‬
E‫א‬‫א‬‫א‬‫א‬‫א‬F

Medicinal Product
New Drugs, Generics (Multisource), Biologicals and
 New  Renewal
Registration No:
This application form is used to apply for ‫א‬

a marketing authorization of a medicinal
‫א‬‫א‬،‫א‬‫א‬
product for human use submitted to Saudi
Food & Drug Authority (SFDA).  K‫א‬‫א‬‫א‬
 
      
A separate application form is needed
for each strength, dosage form, and K
flavor.
Mar 2014
1 Type of Application
The following sections should be completed where appropriate.
1.1 This application concerns:
 New Drug
 Generic (Multisource)
 Biological
 Radiopharmaceutical
1.2 Please provide the following information for the product:
1.2.1 New Drug Application
 Known active substance  New Chemical Entity (NCE)
Is Saudi Arabia the country of origin(COO)?
 Yes (go to section 2)
 No (complete the following information)
Product information in COO:
 Trade name:
 Product strength/unit:
 Dosage form:
 Marketing Authorization holder:
o Name:
o Address :
 Line 1:
 Line 2:
 Line 3:
 Postal/Zip code:
 City:
Mar 2014
 Country:
o Certifying Authority:
o Date of authorization (dd/mm/yyyy):
o Country:
1.2.2 Generic (Multisource) Drug Application
1.2.2.1 Generic drug information:
Is Saudi Arabia the country of origin (COO)?
 Yes (complete part 1.2.2.2)
Product information:
 Trade name:
 Dosage form:
o Name:
o Address :
 Line 1:
 Line 2:
 Line 3:
 City:
 Country:
o Country:
1.2.2.2 Reference Product information in KSA:
Mar 2014
 Trade name:
 Dosage form:
1.2.3 Biological Application
 Biological
 Biosimilar
 Blood product
 Vaccine
 Others (please specify):
Is Saudi Arabia the country of origin (COO)?
 Trade name:
 Dosage form:
 Marketing authorization holder:
o Name:
o Address :
 Line 1:
 Line 2:
 Line 3:
 City:
 Country:
Mar 2014
o Country:
1.2.4 Radiopharmaceutical Application
 Trade name:
 Dosage form:
 Marketing authorization holder information in COO:
o Name:
o Address :
 Line 1:
 Line 2:
 Line 3:
 City:
 Country:
o Country:
Mar 2014
2 Marketing Authorization Application Details
2.1 Name(s) and ATC code:
2.1.1 Proposed trade name:
2.1.2 List the active substance(s):
 Single active substance  Multiple active substances
Name of active Reference/Monograph

Quantity Unit
substance(s) standard
2.1.3 Pharmacotherapeutic group: (Please use current ATC code)
ATC Code Group
 No ATC code has been assigned
2.1.2 List the excipient(s):
Name of Reference/Monograph
Quantity Unit
excipient(s) standard
2.2 Product information:
Manufacturer name:
Manufacturing site: City:
Country:
Mar 2014
Dosage form:
Strength/unit:
Package size(s):
Unit of
Package size Volume
Volume
Route of administration:
Administration device (if applicable):
Primary packaging:
Secondary packaging:
Proposed shelf life:
Proposed shelf life after first opening container (if applicable):
Proposed shelf life after reconstitution or dilution (if applicable):
Proposed storage conditions:
Proposed storage conditions after first opening (if applicable):
Reference Pharmacopoeia:
2.3 Marketing Authorization Holder/Contact Person(s)/Company

Details:
2.3.1 Proposed marketing authorization holder/person legally

responsible for placing the product on the market in KSA:
 Company Name:
 Person Name:
o First name:
o Middle name:
o Family/last name:
 Address:
Mar 2014
o Line 1:
o Line 2:
o Line 3:
o Postal/Zip code:
o City:
o Country:
 Phone:
 Fax:
 E-Mail:
2.3.2 Person/Company authorized for communication in KSA on behalf

of the applicant:
 Person Name:
o First name:
o Middle name:
o Family/last name:
 Company Name:
 Address:
o Line 1:
o Line 2:
o Line 3:
o Postal/Zip code:
o City:
o Country:
 Phone:
 Fax:
 E-Mail:
Mar 2014
2.3.3 Person/Company authorized for communication between the
marketing authorization holder and the SFDA after authorization, if
different from 2.3.2 in KSA:
 Person Name:
o First name:
o Middle name:
o Family/last name:
 Company Name:
 Address:
o Line 1:
o Line 2:
o Line 3:
o Postal/Zip code:
o City:
o Country:
 Phone:
 Fax:
 E-Mail:
2.3.4 Person qualified for Pharmacovigilance in KSA:
 Name:
o First name:
o Middle name:
o Family/last name:
 Address:
o Line 1:
o Line 2:
o Line 3:
Mar 2014
o Postal/Zip code:
o City:
o Country:
 Phone:
 Fax:
 E-Mail:
2.4 Manufacturers:
2.4.1 Active Pharmaceutical Ingredient (API) manufacturer:
Is it GMP Date of
Name of Name of Certifying
Address6 Phone Fax Activity certified? certification
manufacturer ingredient Authority
Yes No (dd/mm/yyyy)
 
 
2.4.2 Excipients manufacturer:
Is it GMP Date of
manufacturer excipient Authority
Yes No (dd/mm/yyyy)
 
 
2.4.3 Finished Product manufacturer:
2.4.3.1 Do you have a valid inspection report from the MoH or SFDA in
the past 5 years?
 Yes  No (go to 2.4.3.2)
2.4.3.2 What is the appropriate time for the visit?
2.4.3.3 Is this product under-licensed?

 Yes  No  Not applicable
6
Full address as Line 1, 2 & 3; Postal/Zip code, City & Country
Mar 2014
Is it GMP Date of
Name of Certifying
manufacturer Authority
Yes No (dd/mm/yyyy)
 
 
2.5 Certificate of a Pharmaceutical Product (CPP):
Do you have a CPP?  Yes  No
If not, do you have a marketing authorization (or free sales) certificate

from the country of origin (COO)?  Yes  No
2.6. List and specify any material of animal source contained in any
component of the product, if applicable:
Material Animal Animal part Free from BSE/TSE




 Please note that any pork content has to be clearly specified.

 It should be noted that all material used must be free from BSE/TSE.
If a certificate confirming that the product is free from BSE/TSE is
available, it should be provided.
Mar 2014
3 Scientific Advice
3.1 Was there any formal scientific advice given by the SFDA for this
medicinal product?
 Yes
 No
If yes:
 Date (dd/mm/yyyy):
 Reference number of the scientific advice letter:
Mar 2014
4 Pediatric Development Program
4.1. Is there a pediatric development program for this medicinal product?
 Yes
 No
If yes, please indicate the relevant section(s) in the dossier.
Mar 2014
5 Status of the application in other regulatory agencies
Tick the appropriate box and fill the information.
Authorized
List all countries where the product is authorized for marketing:
Marketing Date of
Trade Product Dosage
Country authorization authorization
name strength/unit form
holder (dd/mm/yyyy)
Pending
List all countries where the product application is pending:
Date of
Country submission
(dd/mm/yyyy)
Refused
List all countries where the product has been refused for marketing:
Trade Product Dosage Reason for Date of refusal

Country
name strength/unit form refusal (dd/mm/yyyy)
Withdrawn (by applicant after authorization)
List all countries where the product has been withdrawn after authorization:
Date of
Trade Product Dosage Reason for
Country withdrawal
name strength/unit form withdrawal
(dd/mm/yyyy)
Mar 2014
Suspended/revoked (by competent authority)
List all countries where the product has been suspended or revoked:
Date of
Reason for
Trade Product Dosage suspension/rev
Country suspension/
name strength/unit form ocation
revocation:
(dd/mm/yyyy)
Mar 2014
Declaration:
I hereby certify that the submitted information is true and accurate and changes
will not be made until they are approved by SFDA.
Company Director/CEO:
Signature:
Date:
Mar 2014
 ‫א‬‫א‬‫א‬
Marketing Authorization Application of

Medicinal Product for Veterinary Use
 New  Renewal
Registration No:
This application form is used to apply for ‫א‬

a marketing authorization of a medicinal
‫א‬،‫א‬‫א‬
product for veterinary use submitted to
Saudi Food & Drug Authority (SFDA). K‫א‬‫א‬‫א‬‫א‬
A separate application form is needed  

for each strength, dosage form, and
K
flavor.
Mar 2014
 New Drug
 Generic (Multisource)
 Biological
1.2.1 New Drug Application
 Known active substance  New Chemical Entity (NCE)

Product information in the COO:
 Trade name:
 Dosage form:
o Name:
o Address:
 Line 1:
 Line 2:
 Line 3
 City:
 Country:
o Date of authorization(dd/mm/yyyy):
o Country:
Mar 2014
1.2.2 Generic (Multisource) Drug Application
 Yes (complete section 1.2.2.2)
 No (complete section 1.2.2.1)
1.2.2.1 Generic drug information:
 Trade name:
 Dosage form:
o Name:
o Address:
 Line 1:
 Line 2:
 Line 3
 City:
 Country:
o Country:
1.2.2.2 Reference product information in KSA:
 Trade name:
 Dosage form:
Mar 2014
1.2.3 Biologicals Application
 Biosimilar
 Blood product
 Vaccine
 Others (please specify):
 Yes (go to sections 1.3)
 Trade name:
 Dosage form:
 Marketing authorization holder:
o Name:
o Address:
 Line 1:
 Line 2:
 Line 3
 City:
 Country:
o Country:
Mar 2014
1.3 Maximum Residual Limit (MRL) Status: (only for food producing
species)
Substance(s) Species Target tissue(s) MRL Remarks
Withdrawal Period/Unit:
Mar 2014
2.1 Name(s) and ATC code:
2.1.1 Proposed trade name:
2.1.2 List the active substance(s):

Quantity Unit
2.1.3 Pharmacotherapeutic group: (Please use current ATCvet code)
ATCvet Code Group
 No ATC code has been assigned
2.1.4 List the excipient(s):
Quantity Unit
2.2 Product information:
Manufacturer name:
Country:
Dosage form:
Mar 2014
Strength/unit:
Package size(s):
Unit of
Package size Volume
Volume
Primary packaging:

Details

 Company Name:
 Person Name:
o First name:
o Middle name:
o Family/last name:
 Address:
o Line 1:
Mar 2014
o Line 2:
o Line 3
o Postal/Zip code:
o City:
o Country:
 Phone:
 Fax:
 E-Mail:

of the applicant:
 Person Name:
o First name:
o Middle name:
o Family/last name:
 Company Name:
 Address:
o Line 1:
o Line 2:
o Line 3
o Postal/Zip code:
o City:
o Country:
 Phone:
 Fax:
 E-Mail:
Mar 2014
 Person Name:
o First name:
o Middle name:
o Family/last name:
 Company Name:
 Address:
o Line 1:
o Line 2:
o Line 3
o Postal/Zip code:
o City:
o Country:
 Phone:
 Fax:
 E-Mail:
2.4 Manufacturers:
2.4.1 Active Pharmaceutical Ingredient (API) manufacturer:
Is it GMP Date of
Yes No (dd/mm/yyyy)
 
 
7
Mar 2014
Is it GMP Date of
Name of Name of 5 Certifying
Address Phone Fax Activity certified? certification
Yes No (dd/mm/yyyy)
 
 
2.4.3.1 Do you have a valid inspection report from the MoH or SFDA in
the past 5 years?
 Yes  No (go to 2.4.3.2)
2.4.3.3 Is this product under-license?
Is it GMP Date of
Name of Certifying
Yes No (dd/mm/yyyy)
 
 
2.5 Certificate of a Pharmaceutical Product (CPP)
Do you have a CPP?  Yes  No
If not, do you have a marketing authorization (or free sales) certificate

from the country of origin (COO)?  Yes  No
2.6. List and specify any material of animal source contained in any
Mar 2014
Mar 2014
3 Scientific Advice
3.1 Was there any formal scientific advice given by the SFDA for this
medicinal product?
 Yes
 No
If yes:
 Reference number of the scientific letter:
Mar 2014
Authorized
Marketing Date of
holder (dd/mm/yyyy)
Pending
Date of
Country submission
(dd/mm/yyyy)
Refused

Country
Date of
Country withdrawal
(dd/mm/yyyy)
Mar 2014
Date of
Reason for
Trade Product Dosage suspension/
Country suspension/
name strength/unit form revocation
revocation:
(dd/mm/yyyy)
Mar 2014
Declaration:
Signature:
Date:
Mar 2014
 

Herbal or Health Product
 
 
 
 

 New  Renewal
Registration No:
This application form is used to apply for  ‫א‬

a marketing authorization of a herbal or
،‫א‬‫א‬
health product for human use submitted
to Saudi Food & Drug Authority (SFDA). K‫א‬‫א‬‫א‬‫א‬‫א‬
A separate application form is needed 

for each strength, dosage form, and
K
flavor.
Mar 2014
 Herbal product
 Health product
1.2.1 Herbal product:


 Trade name:
 Dosage form:
o Name:
o Address :
 Line 1:
 Line 2:
 Line 3:
 City:
 Country:
o Country:
Mar 2014
1.2.2 Health product:

 Trade name:
 Dosage form:
o Name:
o Address :
 Line 1:
 Line 2:
 Line 3:
 City:
 Country:
o Country:
Mar 2014
2.1 Name(s):
2.1.1 Herbal Products:
2.1.1.1 Proposed trade name:
2.1.1.2 List the active substance(s):
 Single active substance  Multiple active substances (max 5)

Quantity Unit
2.1.1.3 List the excipient(s):
Quantity Unit
2.1.1.4 Raw plant materials:
2.1.1.4.1 Scientific name, family:
2.1.1.4.2 Traditional or common name (Arabic and/or

English)
2.1.1.4.3 Used parts:
Mar 2014
2.1.2 Health Products:
2.1.2.1 Proposed trade name:
2.1.2.2 List the active substance(s):

Quantity Unit
2.1.2.3 List the excipient(s):
Quantity Unit
2.2 Product Information:
Manufacturer name:
Country:
Dosage form:
Strength/unit:
Package size(s):
Unit of
Package size Volume
Volume
Mar 2014
Primary packaging:
2.3 Legal Status:
Does this product have medical claims?
 Yes
 No
If yes, please specify:

Details:

 Company Name:
 Person Name:
o First name:
o Middle name:
o Family/last name:
 Address:
o Line 1:
Mar 2014
o Line 2:
o Line 3
o Postal/Zip code:
o City:
o Country:
 Country:
 Phone:
 Fax:
 E-Mail:

of the applicant:
 Person Name:
o First name:
o Middle name:
o Family/last name:
 Company Name:
 Address:
o Line 1:
o Line 2:
o Line 3
o Postal/Zip code:
o City:
o Country:
 Phone:
 Fax:
 E-Mail:
Mar 2014
 Person Name:
o First name:
o Middle name:
o Family/last name:
 Company Name:
 Address:
o Line 1:
o Line 2:
o Line 3
o Postal/Zip code:
o City:
o Country:
 Country:
 Phone:
 Fax:
 E-Mail:
2.5 Manufacturers:
2.5.1 Active Ingredient manufacturer (raw material manufacturer):
Is it GMP Date of
Yes No (dd/mm/yyyy)
 
 
8
Mar 2014
Is it GMP Date of
Yes No (dd/mm/yyyy)
 
 
2.5.3.1 Do you have a valid inspection report from the MoH or

SFDA in the past 5 years?
 Yes  No (go to 2.5.3.2)
2.5.3.3 Is this product under-license?
Is it GMP Date of
Name of Certifying
Yes No (dd/mm/yyyy)
 
 
2.6 List and specify any material of animal source contained in any





Mar 2014
3 Scientific Advice
3.1 Was there formal scientific advice given by the SFDA for this medicinal
product?
 Yes
 No
If yes:
 Reference number of the scientific letter:
Mar 2014
Authorized
Marketing Date of
holder (dd/mm/yyyy)
Pending
Date of
Country submission
(dd/mm/yyyy)
Refused

Country
Date of
Country withdrawal
(dd/mm/yyyy)
Mar 2014
Date of
Reason for
Trade Product Dosage suspension/rev
Country suspension/
name strength/unit form ocation
revocation:
(dd/mm/yyyy)
Mar 2014
Declaration:
Signature:
Date:
Mar 2014
‫א‬
Application for Variation to a Marketing

Authorization
Reference Number9:
9
The original application will be retrieved automatically from SDR system
Mar 2014
1. This application concerns10:
 Human Drug  Veterinary Drug
 Herbal Product  Health Product
Trade Name:
Active ingredient(s):
Dosage form:
Strength/unit:
Package size(s):
Primary packaging:
Approved shelf life:
Approved storage conditions:
Marketing authorization holder:
Manufacturer name:
Manufacturing site:
City:
Country:
API Manufacturer name:
API Manufacturer site:
City:
Country:
Marketing authorization holder in KSA (Agent):
10
All information are retrieved from the original application in SDR
Mar 2014
2. Type of the variation:
 Type IA
 Type IB
 Type II
3. Type(s) of variation(s):
 Copy of the relevant page(s) from the Variation Guidelines for

this/these change(s) is attached and the relevant boxes for conditions
and documentation.
 Variations included in this application:
Number and title of variation, as per Date of

Procedure
the GCC guidelines for the variation Implementation
Type 11
requirements
Specific variation applied

a) for, as per the Type
classification guideline
 Precise scope and background for change (Include a description and

background of all the proposed changes with its proposed
classification)
Current12,13 Proposed10,11
11
Date of implementation of Type IA variation should be specified if this variation is implemented prior
SFDA approval
12
Specify the precise present and proposed wording or specification, including dossier section
number(s) at the lowest possible level
13
For SPC, labelling and package leaflet changes, underline or highlight the changed words presented
in the table above or provide as a separate Annex
Mar 2014
Declaration:
Signature:
Date:
Mar 2014

Regulatory Framework For Drug Approvals V 5

Uploaded by

Copyright:

Available Formats

Regulatory Framework For Drug Approvals V 5

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Regulatory Framework For Drug Approvals V 5

Uploaded by

Copyright:

Available Formats

Regulatory

Saudi Food & Drug Authority

Kingdom of Saudi Arabia

Please visit SFDA’s website at http://www.sfda.gov.sa/en/drug for the latest update

Vision & Mission

Version Date Author(s) Comments

DOCUMENT CONTROL ..................................................................................................................... 5

Besides the Market Authorization Application (MAA) of various types of drug

Applicant The company or its representative.

Inquiry Form A form used to collect needed information by the

Validation (Phase I & The process of checking if documents satisfy a certain

The following rules/conditions if met, the submitted drug application will be

1. New Drug and Biological (either registered in an SRA or not).

2. Generic Drug that is equivalent to the registered innovator in an SRA (the

3. Biosimilar drug only if it is manufactured locally.

4. Biosimilar drug if registered in an SRA.

5. Combination products (2 or more API):

b. If one or more of the API's are not registered in KSA, or registered

 Performance targets will differ depending on the type of drug.

The process of submitting a NEW drug application2 to the SFDA consists of

1. Online submission of the APPLICATION FORM,

2. The PRODUCT FILE delivered in person,

Step by step procedure:

1. Applicant shall go to the Saudi Drug Registration system (SDR) website

 Submission fees are mandatory in order to proceed to the next step.

 The applicant can reschedule 3 weeks before the appointment. An

 A reference number will be generated, and this number should always be

6. The Regulatory Affairs Pharmacist will validate (Phase I) the following:

a. The application form

b. The product file (hard and soft copy)

 If the above are valid, an acknowledgment letter will be generated and

 If some of the above are missing or not satisfactory, an acknowledgment

 Currently for renewal applications, no appointment scheduling is required.

A. Validation (Phase II):

2. The meeting minutes:

Total performance target =

a) Generics: 165 days

The Renewal of Marketing Authorization will be subjected to the following processes:

A. Validation (Phase II):

E. Marketing Authorization Renewal:

Total performance target = 70 days

Figure 3: Schematic figure showing the renewal process of a marketing authorization

The variation or post-marketing changes can be classified into two categories:

The variation will be subjected to the following processes:

A. Validation (Phase II):

2. For type IB:

3. For type II:

2. The meeting minutes:

Total performance target (Type IA) = 60 days

Figure 4: Schematic figure showing the workflow of Variation

Process Total Performance Target5

Marketing Authorization Application for Generics 165 days

Marketing Authorization Application for New Drugs 290 days

Marketing Authorization Application for New Drugs

Marketing Authorization Application for Biologicals 290 days

Marketing Authorization Application for Biologicals

Marketing Authorization Application for

Marketing Authorization Application for Veterinary

Marketing Authorization Application for Herbal &