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DS-G-031-V2.2/130416
Data Requirements for Herbal &
Health Products Submission
Content of the Dossier
Version 2.2
DS-G-031-V2.2/130416
Saudi Food and Drug Authority
Vision
Mission
DS-G-031-V2.2/130416
Document Control
Executive Directorate of
1.1 16 April 2013 Final
Products Evaluation
Executive Directorate of
1.2 12 February 2014 Update
Products Evaluation
Executive Directorate of
2.1 10 August 2020 Update
Products Evaluation
Update
Executive Directorate of
2.2 06 June 2022
Products Evaluation (Next page shows the
updated details)
DS-G-031-V2.2/130416
What is New in version no. 2.2?
3.2.S.3.1 Elucidation of
Structure and Other Changed from "Required document" to "if applicable"
Characteristics
Add:
3.2.S.2.1
In the case of multiple sites, the role of each site should be
Manufacturer(s)
clarified.
Appendix 1 Update:
Isopropanol 70%.
DS-G-031-V2.2/130416
Table of Contents
1. INTRODUCTION ....................................................................................................... 7
2. DOCUMENTATION .................................................................................................. 8
Table 1: The CTD Structure for both health and herbal product submission ........ 8
3. APPENDIX ................................................................................................................... 37
Appendix 1 ................................................................................................................... 37
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1. INTRODUCTION
1.1. Objectives
1.2. Background
The SFDA has classified products that fall under this guidance into two categories:
• Health Products.
• Herbal Products.
SFDA will employ a risk-based approach taking into consideration elements of the
product’s quality, safety and efficacy.
1.3. Scope
This guideline clarifies the requirements for registration of products that are
classified as herbal products or health products.
For more information, please refer to the SFDA’s Products Classification Guidance.
• Guidance for Presenting PIL and Labeling Information of Herbal and Health Products
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2. DOCUMENTATION
Table 1: The CTD Structure for both health and herbal product
submission
Section Requirements
Module 1 Regional Administrative Information
1.0 Cover letter R1
1.1 Comprehensive table of content R
1.2 Application Form R
1.3 Product Information
1.3.1 Summary of Product Characteristics (SPC) O2
1.3.2 Labeling R
1.3.3 Patient information leaflet (PIL)
1.3.3.1 Arabic leaflet IA3
1.3.3.2 English leaflet IA
1.3.4 Artwork (Mock-ups) R
1.3.5 Samples R
1.7 Certificates and Documents
1.7.1 GMP Certificate R
1.7.2 CPP or Free-sales R
1.7.3 Certificate of analysis – Drug Substance / Finished Product R
1.7.4 Certificate of analysis – Excipients R
1.7.5 Alcohol-free declaration R
1.7.6 Pork- free declaration R
1.7.7 Certificate of suitability for TSE R
1.7.8 The diluents and coloring agents in the product formula IA
1.7.10 Letter of access or acknowledgment to DMF IA
1.7.11 Commercial Agency contract IA
1.8 Pricing
1.8.1 Price list IA
1.8.2 Other documents related IA
1.9 Responses to questions R
Module 3 Quality
3.1 Table of Contents of Module 3 R
1
R: Required
2
O: Optional (optional means that it might not be needed at this stage or not needed at all depending on
the product status and the course of the evaluation process)
3
IA: if applicable
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3.2 Body of data
3.2.S Drug Substance
3.2.S.1 General Information
3.2.S.1.1 Nomenclature R
3.2.S.1.2 Structure R
3.2.S.1.3 General Properties R
3.2.S.2 Manufacture
3.2.S.2.1 Manufacturer(s) R
3.2.S.2.2 Description of Manufacturing Process and Process Controls R
3.2.S.2.3 Control of Materials O
3.2.S.2.4 Control of Critical Steps and Intermediates O
3.2.S.2.5 Process Validation and/or Evaluation O
3.2.S.2.6 Manufacturing Process Development O
3.2.S.3 Characterization
3.2.S.3.1 Elucidation of Structure and Other Characteristics IA
3.2.S.3.2 Impurities R
3.2.S.4 Control of Drug Substance
3.2.S.4.1 Specifications R
3.2.S.4.2 Analytical Procedures R
3.2.S.4.3 Validation of Analytical Procedures IA
3.2.S.4.4 Batch Analyses R
3.2.S.4.5 Justification of Specification R
3.2.S.5 Reference Standards or Materials IA
3.2.S.6 Container/Closure Systems O
3.2.S.7 Stability
3.2.S.7.1 Stability Summary and Conclusions O
3.2.S.7.2 Post-approval Stability Protocol and Commitment O
3.2.S.7.3 Stability Data O
3.2.P Drug Product
3.2.P.1 Description and Composition of the Drug Product R
3.2.P.2 Pharmaceutical Development
3.2.P.2.1 Components of the Drug Product
3.2.P.2.1.1 Drug substance(s) O
3.2.P.2.1.2 Excipients O
3.2.P.2.2 Drug Product
3.2.P.2.2.1 Formulation Development IA
3.2.P.2.2.2 Overages R
3.2.P.2.2.3 Physiochemical and Biological Properties IA
3.2.P.2.3 Manufacturing Process Development O
3.2.P.2.4 Container Closure System O
3.2.P.2.5 Microbiological Attributes O
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3.2.P.2.6 Compatibility O
3.2.P.3 Manufacture
3.2.P.3.1 Manufacturer(s) R
3.2.P.3.2 Batch Formula R
3.2.P.3.3 Description of Manufacturing Process and Process Controls R
3.2.P.3.4 Controls of Critical Steps and Intermediates O
3.2.P.3.5 Process Validation and/or Evaluation O
3.2.P.4 Control of Excipients
3.2.P.4.1 Specifications R
3.2.P.4.2 Analytical Procedures O
3.2.P.4.3 Validation of Analytical Procedures O
3.2.P.4.4 Justification of Specifications IA
3.2.P.4.5 Excipients of Human or Animal Origin IA
3.2.P.4.6 Novel Excipients IA
3.2.P.5 Control of Drug Product
3.2.P.5.1 Specifications R
3.2.P.5.2 Analytical Procedures R
3.2.P.5.3 Validation of Analytical Procedures IA
3.2.P.5.4 Batch Analyses R
3.2.P.5.5 Characterization of Impurities IA
3.2.P.5.6 Justification of Specifications R
3.2.P.6 Reference Standards or Materials IA
3.2.P.7 Container/Closure System R
3.2.P.8 Stability
3.2.P.8.1 Stability Summary and Conclusions R
3.2.P.8.2 Post-Approval Stability Protocol and Stability Commitments R
3.2.P.8.3 Stability Data R
3.3 Literature References IA
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2.1. Part 1 Administrative Information
Note: the certificate must be issued from a regulatory agency and certified by the Saudi
embassy.
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submitted from the supplier (drug substance manufacturer).
- Certificates of analysis for at least one batch of the drug substance should be
submitted from the supplier finished product manufacturer.
- Certificates of analysis for more than one batch of the finished product should be
submitted.
In case of having a pharmacopeial excipient, the specifications sheet must cover all the
pharmacopeial parameters
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1.7.11. Commercial Agency contract
A valid commercial agency contract (or equivalent) should be submitted.
Module 3 Quality
The drug substance information submitted should include the following for each of the
options used.
A complete copy of the CEP (including any annexes) should be provided in Module 1.
Along with the CEP, the applicant should submit the following:
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Studies to identify polymorphs (exception: where the CEP specifies a
polymorphic form) and particle size distribution, where applicable.
c) 3.2.S.4.1 Specifications
The specifications of the finished product manufacturer including all tests and
limits of the CEP and Ph. Eur. monograph and any additional tests and acceptance
criteria that are not controlled in the CEP and Ph. Eur. monograph, such as
polymorphs and/or particle size distribution.
For any tests in addition to those in the CEP and Ph. Eur. monograph.
Results from three batches of at least pilot scale, demonstrating compliance with
the finished product manufacturer’s API specifications.
h) 3.2.S.7 Stability
The stability can be included in this section, except where the CEP specifies a re-
test period that is the same as or of longer duration than the re-test period proposed
by the applicant.
Full details of the chemistry, manufacturing process, quality controls during manufacturing
and process validation for the drug substance may be submitted as DMF. In such cases, the
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Open part needs to be included in its entirety in the dossier as an annex to 3.2.S. In addition,
the applicant/finished product manufacturer can complete the following sections:
b) 3.2.S.2 Manufacture
3.2.S.2.1 Manufacturer(s)
d) 3.2.S.3.2 Impurities
Information on the 3.2.S Drug Substance sections, including relevant details of chemistry,
manufacturing process, quality controls during manufacturing for the drug substance,
should be submitted in the dossier as outlined in the subsequent sections of this guideline.
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Active Substance(s):
Excipient(s):
3.2.S.1.1 Nomenclature
For herbal substance(s), the following information should be provided:
• Binomial scientific name of plant (genus, species, variety and author), and chemotype
(where applicable).
• Laboratory code.
• Binomial scientific name of plant (genus, species, variety and author), and chemotype
(where applicable).
• Laboratory code.
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• Extraction solvent(s).
3.2.S.1.2 Structure
The following information, where applicable, should be provided:
• Physical form.
• Other constituent(s).
3.2.S.2 Manufacture
3.2.S.2.1 Manufacturer(s)
The name(s) and complete postal address(es) of the manufacturing, packaging and testing
site(s) of the active ingredient(s) should be provided, In the case of multiple sites, the role
of each site should be clarified.
This applies to both health and herbal products. Additionally, for herbal substance(s),
information should be provided to adequately describe the plant production and plant
collection for herbal products, including:
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• Batch size.
For the herbal preparation, Information should be provided to adequately describe the
manufacturing process of the herbal preparation as follows, including data on the herbal
substance as described above.
Materials used in the manufacture of the drug substance (e.g., raw materials, starting
materials, solvents, reagents, catalysts) can be listed identifying where each material is
used in the process. Information on the quality and control of these materials can be
provided in addition to information demonstrating that materials meet standards
appropriate for their intended use.
Critical Steps: Tests and acceptance criteria (with justification including experimental data)
performed at critical steps of the manufacturing process to ensure that the process is
controlled.
Intermediates: Information on the quality and control of intermediates isolated during the
process.
Process validation and/or evaluation studies for aseptic processing and sterilization.
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A brief summary describing the development of the herbal substance(s) and herbal
preparation(s) where applicable, taking into consideration the proposed route of
administration and usage. Results comparing the phytochemical composition of the herbal
substance(s) and herbal preparation(s) where applicable used in supporting bibliographic
data and the herbal substance(s) and herbal preparation(s) where applicable described in
S1 be discussed, where appropriate.
3.2.S.3 Characterization
3.2.S.3.1 Elucidation of Structure and Other Characteristics
For herbal substances
3.2.S.3.2 Impurities
For herbal substances
As a general rule, herbal substances must be tested, unless otherwise justified, for
microbiological quality and for residues of pesticides and fumigation agents, toxic metals,
likely contaminants and adulterants, etc. The use of ethylene oxide is prohibited for the
decontamination of herbal substances.
In addition to the above, the concentration limits for process-related impurities (e.g.,
residual solvents) as per the applicable ICH guidance document should be discussed.
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criteria and reference of each tested parameter (e.g., USP, BP, in-house… etc). Copies of
the drug substance specifications, dated and signed by the concerned individual(s) should
be provided, including specifications for each drug substance manufacturer as well as those
of the finished product manufacturer.
− Characteristics.
− Identification tests.
− Purity tests:
For standardized herbal preparation, the content of constituents with known therapeutic
activity must be indicated with the lowest possible tolerance (with both upper and lower
limits). In the case of active markers used for quantified extracts the content of the markers
has to be given as a defined range. In the case of an analytical marker of an extract for
which neither constituents of known therapeutic activity, nor active markers are known,
the specified minimum and maximum content is related to the validated analytical range
as a base for analytical suitability within the frame of batch related control. The test
methods should be described in detail.
If preparations from herbal substances with constituents of known therapeutic activity are
standardized (i.e. adjusted to a defined content of constituents with known therapeutic
activity) it should be stated how such standardisation is achieved. If another substance is
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used for these purposes, it is necessary to specify as a range the quantity that can be added.
Copies of the in-house analytical procedures used to generate testing results provided in
the dossier, as well as those proposed for routine testing of the drug substance by the
finished product manufacturer, should be provided. Unless modified, it is not necessary to
provide copies of the compendial analytical procedures.
Validation data are not required for methods described in the Pharmacopeias.
Description of batches and results of batch analyses should be provided. This would
include information such as batch number, batch size, date and site of production, …etc.
Certificates of analysis for at least two recent, commercial-scale production batches should
be provided. If data on commercial-scale batches are not available, certificates of analysis
should be provided for pilot-scale batches manufactured using the same process as intended
for commercial-scale batches.
The discussion of results should focus on observations noted for the various tests, rather
than reporting comments such as “all tests meet specifications”. For quantitative tests (e.g.
assay test, individual and total impurity tests), it should be ensured that actual numerical
results are provided rather than vague statements such as “within limits” or “conforms”.
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3.2.S.4.5 Justification of Specification
Justification for the proposed specification(s) should be provided. This should include a
discussion on the inclusion of certain tests, analytical procedures and acceptance criteria.
If the compendial methods have been modified or replaced, a discussion should be
included. The justification for certain tests, analytical procedures and acceptance criteria
may have been discussed in other sections (e.g. impurities) and does not need to be repeated
here, although a cross-reference to their location should be provided.
A description of the container closure system(s) can be provided, including the identity of
materials of construction of each primary packaging component, and their specifications.
The specifications include description, identification and critical dimensions with
drawings, where appropriate.
For non-functional secondary packaging components (e.g., those that do not provide
additional protection), only a brief description should be provided. For functional
secondary packaging components, additional information should be provided.
The suitability should be discussed with respect to, for example, choice of materials,
protection from moisture and light, compatibility of the materials of construction with drug
substance(s), including sorption to container and leaching, and/or safety of materials of
construction.
3.2.S.7 Stability
The GCC guidelines for "Stability Testing of Active Pharmaceutical Ingredients and
Finished Pharmaceutical Products (FPPs)" should be consulted for recommendations on
the stability data required for the drug substance(s) and finished product(s).
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The types of studies conducted, protocols used, and the results of the studies can be
summarized. The summary includes information on storage conditions, batch number,
batch size, container closure system and completed (and proposed) test intervals, results
and conclusions with respect to storage conditions and retest date or shelf-life, as
appropriate.
The discussion of results focuses on observations noted for the various tests, rather than
reporting comments such as “all tests meet specifications”. Where the methods used in the
stability studies are different from those described in S.4.2, descriptions and validation of
the methodology used in stability studies can be provided.
The post-approval stability protocol and stability commitment can be provided. In case
long-term stability data do not cover the proposed re-test period granted at the time of
assessment of the dossier, a commitment should be made to continue the stability studies
in order to firmly establish the re-test period. A written commitment (signed and dated) to
continue long- term testing over the re-test period should be included in the dossier when
relevant.
Results of the stability studies can be presented in a tabular format and data for all testing
parameters per each batch should be presented in one summary table. For quantitative tests
(e.g. individual and total degradation product tests and assay tests), it should be ensured
that actual numerical results are provided rather than vague statements such as “within
limits” or “conforms”. Information on the analytical procedures used to generate the data
and validation of these procedures can be included.
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• Description of the dosage form;
• Composition, i.e.:
• Type of container and closure used for the dosage form and accompanying reconstitution
diluent, if applicable.
3.2.P.2.1.2 Excipients
The choice of excipients, their concentration, their characteristics that can influence the
performance of the product is expected be discussed relative to their respective functions.
A brief summary describing the development of the product, taking into consideration the
proposed route of administration and usage. Results comparing the phytochemical
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composition of the products used in supporting bibliographic data and the product
described in 3.2.P.1 can be discussed, where appropriate.
3.2.P.2.2.2 Overages
Any overages added to the formulation should be justified. If overages are added to
compensate for losses of the active ingredient(s) during the manufacturing process, the
stage(s) of manufacture where the loss of active ingredient(s) occurs should be identified.
Overages for the sole purpose of extending the shelf-life of the finished product are
generally not acceptable.
Parameters relevant to the performance of the product, such as pH, ionic strength,
dissolution, redispersion, reconstitution, particle size distribution, aggregation,
polymorphism, rheological properties, biological activity or potency, and/or
immunological activity.
The selection and optimization of the manufacturing process and, in particular its critical
aspects, should be explained. The scientific rationale for the choice of the manufacturing,
filling, and packaging processes that can influence drug product quality and performance
can be discussed. The equipment can be identified by type and working capacity.
The suitability of the container closure system (described in 3.2.P.7) used for the storage,
transportation (shipping) and use of the product is to be discussed. This discussion should
consider, e.g., choice of materials, protection from moisture and light, compatibility of the
materials of construction with the dosage form (including sorption to container and
leaching), and performance (such as reproducibility of the dose delivery from the device
when presented as part of the product). In case of using new packaging materials, the
discussion should include the safety of those materials, in addition to the above mentioned
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requirements.
For a device accompanying a multidose container, the discussion should provide the results
that demonstrate the reproducibility of the device (e.g. consistent delivery of the intended
volume), generally at the lowest intended dose.
Where appropriate, the microbiological attributes of the dosage form should be discussed,
including, for example, the rationale for not performing microbial limits testing for non-
sterile products and the selection and effectiveness of preservative systems in products
containing antimicrobial preservatives. A single primary stability batch of the finished
product should be tested for effectiveness of the antimicrobial preservative (in addition to
preservative content) at the proposed shelf-life for verification purposes, regardless of
whether there is a difference between the release and shelf-life acceptance criteria for
preservative content.
3.2.P.2.6 Compatibility
The compatibility of the product with reconstitution diluent(s) or dosage devices (e.g.,
precipitation of substance(s) in solution, stability) can be addressed to provide appropriate
and supportive information for the labeling.
3.2.P.3 Manufacture
3.2.P.3.1 Manufacturer(s)
The Name (s) and complete postal address (es) of the manufacturing, packaging and testing
site (s) of the finished product should be provided.
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medicinal ingredient should also be described.
Appropriate tests and acceptance criteria (with justification, including experimental data)
for critical steps identified in 3.2.P.3.3 of the manufacturing process to ensure that the
process is controlled. Information on the quality and control of intermediates isolated
during the process can be provided.
Description, documentation, and results of the validation and/or evaluation studies can be
provided for critical steps or critical assays used in the manufacturing process (e.g.,
validation of the sterilization process or aseptic processing or filling).
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3.2.P.4.4 Justification of Specifications
Justification for the proposed excipient specifications should be provided in case of in-
house specifications.
Excipients that are of human or animal origin (including country of origin) are to be listed.
Summary of the information (e.g., sources, specifications, description of the testing
performed, viral safety data) regarding adventitious agents for excipients of human or
animal origin should be provided.
For excipients obtained from sources that are at risk of transmitting Bovine Spongiform
For excipient(s) used for the first time in a product or by a new route of administration, full
details of manufacture, characterization, and controls, with cross references to supporting
safety data (non-clinical and/or clinical) should be provided
3.2.P.5.1 Specifications
A copy of the specifications for the finished product signed and dated by authorized
personnel (person in charge of quality control or quality assurance department) should be
submitted.
The analytical procedures used for testing the product should be provided. Copies of non-
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compendial analytical procedures used during pharmaceutical development (if used to
generate testing results provided in the dossier) as well as those proposed for routine testing
should be provided. Unless modified, it is not necessary to provide copies of the
compendial analytical procedures.
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Certificates of analyses should be submitted for at least two batches of the finished product.
Justification for the proposed drug product specification(s) should be provided. The
discussion should be provided on the omission or inclusion of certain tests, evolution of
tests, analytical procedures, and acceptance criteria, differences from compendial
standard(s), etc. If the compendial methods have been modified or replaced, a discussion
should be included.
The justification for certain tests, analytical procedures and acceptance criteria (e.g.
degradation products) may have been discussed in other sections of the dossier and does
not need to be repeated here, although a cross-reference to their location should be
provided.
Information on the reference standards or reference materials used for testing of the product
should include the following, if not previously provided in "3.2.S.5 Reference Standards
or Materials":
1. The source of reference standards or reference materials (e.g., House, USP, BP, Ph.
Eur.).
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A description of the container-closure system should be provided, including the identity of
materials of construction of each primary and secondary packaging component.
3.2.P.8 Stability
Every manufacturer should define the period of time during which, after being packaged
for sale, the product will maintain its purity and physical characteristics and its medicinal
ingredients will maintain their quantity per dosage unit and their potency. Therefore, the
sponsor of the products is responsible for the shelf life. The sponsor must ensure that
stability data exists to support the shelf life. The shelf life must be based on scientific data.
SFDA may check the data through the internal regulatory mechanisms. The maximum shelf
life permitted is five years and applies to the product in its final container. The maximum
shelf life permitted is five years and applies to the product in its final container. Long-term
stability study performed at storage condition (25 oC ± 2 oC / 60% RH ± 5% RH) can be
accepted, however for products containing chemically synthesized material(s) (e.g.:
antiseptic or antilice..etc), the study should be conducted at (30 oC ± 2 oC / 65% RH ± 5%
RH).
Where the submission includes long-term stability data on three production batches
covering the proposed shelf-life period, a post-approval commitment is considered
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unnecessary. Otherwise one of the following commitments should be made:
− If the submission includes data from stability studies on three production batches, a
written commitment (signed and dated) should be made to continue these studies through
the proposed shelf-life period.
− If the submission includes data from stability studies on less than three production
batches, a written commitment (signed and dated) should be made to continue these studies
through the proposed shelf-life period and to place additional production batches, to a total
of at least three, in long-term stability studies through the proposed shelf-life period.
− If the submission does not include stability data on production batches, a written
commitment (signed and dated) should be made to place the first three production batches
on long term stability studies through the proposed shelf-life period.
The stability protocol for the commitment batches should be provided and should include,
but not be limited to, the following parameters:
• Acceptance criteria;
The stability of the drug product should be monitored over its shelf-life to determine that
the product remains within its specifications and to detect any stability issue (e.g. changes
in levels of degradation products). For this purpose, the ongoing stability programme
should include at least one production batch per year of product manufactured in every
strength and every container closure system (unless none is produced during that year).
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Therefore, a written commitment (signed and dated) for ongoing stability studies should
be included in the dossier.
Any differences in the stability protocols used for the primary batches and those proposed
for the commitment batches or ongoing batches should be scientifically justified.
Results of the stability studies for at least 12 months should be available at submission and
presented in a tabular format. The results of all testing parameters related to each batch for
the entire testing period should be presented in one table (i.e. presenting the results of one
parameter of all batches in one table is not acceptable).
The actual stability results/reports used to support the proposed shelf-life should be
provided in the dossier. For quantitative tests (e.g. individual and total degradation product
tests and assay tests), it should be ensured that actual numerical results are provided rather
than vague statements such as “within limits” or “conforms”. Dissolution results should be
expressed at minimum as both the average and range of individual results. Information on
the analytical procedures used to generate the data and validation of these procedures
should be included. Information on characterization of impurities is located in 3.2.P.5.5.
A list and copies of all bibliographical references cited in support of this application should
be provided. References that have not been provided should be available upon request.
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facilitate the understanding and evaluation of the results.
Efficacy of the product as well as information on the safety of use should be addressed in
this section. For more information regarding evidence to support herbal and health product
applications.
A list of cited references should be provided. References that have not been provided
should be available upon request.
Introduction
Applicants must submit evidence from all relevant sources to support the safety and
efficacy of the product. The required evidence will vary depending on the type of claim
as well as the type of the product.
1. Herbal Product:
Products containing herbs are divided into two categories depending on the nature and
the intended usage of the herbal product:
• A period of at least 30 years of traditional use. The dose and the method of
preparation must be the same as those traditionally used.
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product should have the same active ingredients, indication, strength, pharmaceutical
dosage form, dosing frequency and the same route of administration.
• Official expert committee reports or monographs from learned societies, e.g. WHO,
Commission E, ESCOP etc
Note: The supporting evidence must show that product has been used in practice for at
least 30 years. Reference to a source published 30 years ago is not sufficient, as this
simply demonstrates that the product was in use 30 years ago. There must also be a
connection between the duration of use and the claimed use.
• Clinical Studies: Evidence from clinical studies can provide valuable information
about the efficacy and safety of the herbal product. There are several types of clinical
studies, including; systematic reviews, such as meta-analyses of randomized
controlled trial, randomized controlled trials and non-experimental observational
studies, such as epidemiological, cohort studies.
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• Regulatory documents e.g. assessment report, community herbal monograph etc.
2. Health Product:
Depending on the nature and status of the health product, sources of acceptable evidence
include:
• Clinical Studies: Evidence from clinical studies can provide valuable information
about the efficacy and safety of the herbal product. There are several types of clinical
studies, including; systematic reviews, such as meta-analyses of randomized
controlled trial, randomized controlled trials and non-experimental observational
studies, such as epidemiological, cohort studies.
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3. APPENDIX
Appendix 1
This appendix is a part of the “Data Requirement for Herbal and Health Products
Submission” and addresses health products that have previously been required to be listed
at the Saudi Food and Drug Authority and are now required to be registered as Health
product in order to be marketed in Saudi Arabia.
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8. Topical patches, creams, ointments and gels containing counter irritant ingredient
as an externally applied substance that causes irritation or mild inflammation of the
skin for the temporary relieve of pain in muscles or joints by reducing inflammation
in deeper adjacent structures (these products should comply with the Canadian
Counterirritant monograph).
The following requirements are considered minimum at the time of submission and are
subject to change. The Saudi Food and Drug Authority reserves the right to request
additional documents on a case-by-case basis:
Section Requirements
Module 1 Regional Administrative Information
1.0 Cover letter R
1.1 Comprehensive table of content R
1.2 Application Form R
1.3 Product Information
1.3.1 Summary of Product Characteristics (SPC) O
1.3.2 Labeling R
1.3.3 Patient information leaflet (PIL)
1.3.3.1 Arabic leaflet IA
1.3.3.2 English leaflet IA
1.3.4 Artwork (Mock-ups) R
1.3.5 Samples R
1.7 Certificates and Documents
1.7.1 GMP Certificate O
1.7.2 CPP or Free-sales R
1.7.3 Certificate of analysis – Drug Substance / Finished Product IA
1.7.4 Certificate of analysis – Excipients O
1.7.5 Alcohol-free declaration IA
1.7.6 Pork- free declaration R
1.7.7 Certificate of suitability for TSE IA
1.7.8 The diluents and coloring agents in the product formula IA
1.7.10 Letter of access or acknowledgment to DMF IA
1.7.11 Commercial Agency contract IA
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1.8 Pricing
1.8.1 Price list IA
1.8.2 Other documents related IA
1.9 Responses to questions R
Module 3 Quality
3.1 Table of Contents of Module 3 R
3.2 Body of data
3.2.S Drug Substance
3.2.S.1 General Information
3.2.S.1.1 Nomenclature O
3.2.S.1.2 Structure O
3.2.S.1.3 General Properties O
3.2.S.2 Manufacture
3.2.S.2.1 Manufacturer(s) R
3.2.S.2.2 Description of Manufacturing Process and Process Controls O
3.2.S.2.3 Control of Materials O
3.2.S.2.4 Control of Critical Steps and Intermediates O
3.2.S.2.5 Process Validation and/or Evaluation O
3.2.S.2.6 Manufacturing Process Development O
3.2.S.3 Characterization
3.2.S.3.1 Elucidation of Structure and Other Characteristics O
3.2.S.3.2 Impurities O
3.2.S.4 Control of Drug Substance
3.2.S.4.1 Specifications O
3.2.S.4.2 Analytical Procedures O
3.2.S.4.3 Validation of Analytical Procedures O
3.2.S.4.4 Batch Analyses O
3.2.S.4.5 Justification of Specification O
3.2.S.5 Reference Standards or Materials O
3.2.S.6 Container/Closure Systems O
3.2.S.7 Stability
3.2.S.7.1 Stability Summary and Conclusions O
3.2.S.7.2 Post-approval Stability Protocol and Commitment O
3.2.S.7.3 Stability Data O
3.2.P Drug Product
3.2.P.1 Description and Composition of the Drug Product R
3.2.P.2 Pharmaceutical Development
3.2.P.2.1 Components of the Drug Product
3.2.P.2.1.1 Drug substance(s) O
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3.2.P.2.1.2 Excipients O
3.2.P.2.2 Drug Product
3.2.P.2.2.1 Formulation Development O
3.2.P.2.2.2 Overages O
3.2.P.2.2.3 Physiochemical and Biological Properties O
3.2.P.2.3 Manufacturing Process Development O
3.2.P.2.4 Container Closure System O
3.2.P.2.5 Microbiological Attributes O
3.2.P.2.6 Compatibility O
3.2.P.3 Manufacture
3.2.P.3.1 Manufacturer(s) R
3.2.P.3.2 Batch Formula O
3.2.P.3.3 Description of Manufacturing Process and Process Controls O
3.2.P.3.4 Controls of Critical Steps and Intermediates O
3.2.P.3.5 Process Validation and/or Evaluation O
3.2.P.4 Control of Excipients
3.2.P.4.1 Specifications R
3.2.P.4.2 Analytical Procedures O
3.2.P.4.3 Validation of Analytical Procedures O
3.2.P.4.4 Justification of Specifications O
3.2.P.4.5 Excipients of Human or Animal Origin O
3.2.P.4.6 Novel Excipients O
3.2.P.5 Control of Drug Product
3.2.P.5.1 Specifications R
3.2.P.5.2 Analytical Procedures R
3.2.P.5.3 Validation of Analytical Procedures O
3.2.P.5.4 Batch Analyses R
3.2.P.5.5 Characterization of Impurities O
3.2.P.5.6 Justification of Specifications O
3.2.P.6 Reference Standards or Materials R
3.2.P.7 Container/Closure System R
4
3.2.P.8 Stability
3.2.P.8.1 Stability Summary and Conclusions IA
3.2.P.8.2 Post-Approval Stability Protocol and Stability Commitments O
3.2.P.8.3 Stability Data IA
3.3 Literature References IA
4
Is required for products that claim a shelf life of more than two years
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