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    Introduction Regulatory Affairs Introduction Regulatory Affairs

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    Rajib Kumar Baishnab
    Regulatory affairs professionals act as the interface between pharmaceutical companies and drug regulatory authorities. They are responsible for registering drug products with authorities prior to marketing. Key responsibilities include providing guidance on development, managing clinical trial and marketing applications, and ensuring compliance throughout the product lifecycle. Effective regulatory dossier management is important for timely product approval and launch. Dossiers like CTD and eCTD contain quality, safety and efficacy data in a standardized format required by agencies like FDA, EMA and others around the world.

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    Introduction Regulatory Affairs Introduction Regulatory Affairs

    Uploaded by

    Rajib Kumar Baishnab
    34 views35 pages
    Regulatory affairs professionals act as the interface between pharmaceutical companies and drug regulatory authorities. They are responsible for registering drug products with authorities prior to marketing. Key responsibilities include providing guidance on development, managing clinical trial and marketing applications, and ensuring compliance throughout the product lifecycle. Effective regulatory dossier management is important for timely product approval and launch. Dossiers like CTD and eCTD contain quality, safety and efficacy data in a standardized format required by agencies like FDA, EMA and others around the world.

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    Regulatory affairs professionals act as the interface between pharmaceutical companies and drug regulatory authorities. They are responsible for registering drug products with authorities prior to marketing. Key responsibilities include providing guidance on development, managing clinical trial and marketing applications, and ensuring compliance throughout the product lifecycle. Effective regulatory dossier management is important for timely product approval and launch. Dossiers like CTD and eCTD contain quality, safety and efficacy data in a standardized format required by agencies like FDA, EMA and others around the world.

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    Public Domain
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    34 views35 pages

    Introduction Regulatory Affairs Introduction Regulatory Affairs

    Uploaded by

    Rajib Kumar Baishnab
    Regulatory affairs professionals act as the interface between pharmaceutical companies and drug regulatory authorities. They are responsible for registering drug products with authorities prior to marketing. Key responsibilities include providing guidance on development, managing clinical trial and marketing applications, and ensuring compliance throughout the product lifecycle. Effective regulatory dossier management is important for timely product approval and launch. Dossiers like CTD and eCTD contain quality, safety and efficacy data in a standardized format required by agencies like FDA, EMA and others around the world.

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    of 35

    Introduction‐Regulatory 

    Affairs

    Rajib Kumar Baishnab
    Head of Regulatory Affairs
    Date:04‐01‐2021
    1
    Outline
    • What is Regulatory Affairs & Why Regulatory Affairs
    • Role & Job Profile of Regulatory Affairs Professional
    • Essential Skills of a Regulatory Affairs Professional
    • Regulatory Dossier Management, Preparation & Importance of effective dossier 
    management
    • Types of Dossier
    • Important Regulatory Guidelines & Regulatory Authorities
    What is Regulatory Affairs

    • Regulatory Affairs in a Pharmaceutical industry, is a


    profession which acts as the interface between the
    pharmaceutical industry and Drug Regulatory
    authorities across the world.

    • It is mainly involved in the registration of the drug


    products in respective countries prior to their
    marketing.
    • Regulatory Affairs is a key part of company .It is an affair between the 
    competent authority and an applicant (company) to manage life cycle of 
    the products.
    • RA experts are qualified professional to provide right solution to the 
    technical problems under the light of laws and regulations.
    • Availability of safe, effective and quality pharmaceutical products
    Why Regulatory Affairs
    • Drug  development and commercialization is highly regulated
    • The path of drug registration is laid down with good intention 
    but can be complicated
    • Things change constantly
    • To gather all relevant information in one umbrella to bring 
    product into the market for sell.
    Role of Regulatory Affairs Professional
    Product Life Cycle Perspective
    • Development phase:
    – Advice on Development
    – Scientific advice
    – Clinical trial application
    – Project Management/Regulatory Strategy
    – Product information‐Claims
    • Approval Phase:
    – Application Procedure
    – Authority Meeting/Hearing
    – Paper/Electronic Submission
    – Readability Testing/Labeling support
    • Post Approval Phase:
    – Life cycle Management/ compliance
    – Post‐approval commitments
    – Clinical Trial Applications
    – New Indications
    Job Profile of Regulatory Affairs Professional
    • An average day at work
    – Computer work
    – Read, review and also write documents‐interpret legislation, guidelines etc.
    – Communication/collaboration‐Meeting/e‐mails/TC‐Colleagues‐Business Partners‐
    Medicine Agencies
    – Deadline
    – Learn New Things
    – Fast but still precise
    Essential Skills
    • Regulatory knowledge
    • Critical thinking
    • Writing skills
    • Oral communication
    • Organizing skills
    • Business skills
    • Listening, understanding and being adaptable 
    Regulatory Dossier Management & Preparation
    Dossier
    • Registration Dossier of the pharmaceutical product is a document that contains all 
    the technical data (administrative, quality, nonclinical and clinical) of a 
    pharmaceutical product to be approved / registered / marketed in a country. 

    • It is more commonly called as the New Drug Application (NDA) in the USA or 
    Marketing Authorization Application (MAA) in the European Union (EU) and in 
    some  countries it is called simply “Registration Dossier”.
    Importance of effective dossier management
     The registration dossier for medicines is an important document which is submitted 
    for review to regulatory agencies by pharma companies for approval to market 
    their medicines.
     Utmost care should be taken during its compilation and filing as it plays a direct 
    role in earliest possible availability of medicines in the market which in turn 
    translates into business for the company.
     Of course, regulatory affairs professionals need to ensure the safety, quality and 
    efficacy of  the medicines for which they are filing registration dossier.
    • 3 important aspects which play an important role in effective 
    dossier management‐
     Planning aspects
     Formatting and compilation aspects
     Review aspects
    Planning Aspects

     Deadline‐
     Action Plan should be prepared
     Understanding the registration requirements of respective agencies‐
     Requirement varies from  one Regulatory authority to another
     Requirements Listing‐
     List down all requirements
     Sending the requirements list to respective departments‐
     Prepare individual requirement list and send it to respective department
    Formatting and compilation Aspects

     Format
     Paper size (A4/other format),
     Font (Times New Roman/Arial),
     Margin, pagination, Header /Footer
     Compilation
     Specific, Clear, precise, accurate
     Module arranged in a sequential order
     Cross checked the documents
     Ensure documents prepared as per ICH/other regulatory guidelines
    Review Aspects

     Review
     Every human being is prone to mistakes
     Recheck/Crosscheck
     Checklist
    Types of Dossier
    Common Pharmaceutical Dossier which is widely used in the 
    Pharmaceutical Industry are:
     CTD Dossier
     ACTD Dossier
     eCTD Dossier
     Country Specific Registration Dossier
    CTD(Common Technical Documents)
    • Common Technical Document Consists of the following Modules 
    with the number of the required Documents.
     Module 1 – Administrative Information & Prescribing Information
     Module 2 ‐ Common Technical Documents Summaries
     Module 3 –Quality
     Module 4 – Non Clinical Study Report
     Module 5 – Clinical Study Report
    ACTD (Asean Common Technical Documents)
    • Asian Common Technical Documents consists of following parts.
     Part I – Administrative Data and Product Information
     Part II – Quality Documents
     Part III – Non Clinical Documents
     Part IV – Clinical Documents.
    • eCTD Format Dossier
     Registration Dossier is an electronic format for CTD Dossier, 
     The content is based on the Common Technical Document (CTD) format.
     It was developed by the International Conference on Harmonization 
    (ICH) Multidisciplinary Group  Expert Working Group (ICH M2 EWG).
     Submission in eCTD format should be in accordance with the current 
    ICH M2 EWG eCTD specification
     Electronic files should be in accordance with the Guidance for Industry 
    on Providing Regulatory Information in Electronic Format.
    Country Specific Format Dossier
    • This format of Registration Dossier is in accordance with the Specific Country 
    Regulatory Guidelines.

     Compile and write entire dossier of specified modules as per Guidelines provided 
    by the relevant Government Regulatory Authorities.
    The SMART Process for Preparing Submissions
    Strategy: Plan ahead, first prepare Summary 
    Mapping: Prepare outline with key Messages
    Authoring: The right authors and Accountability
    Reviewing: The right reviewers and Resolution
    Training: Sharing knowledge and Teamwork
    Important Regulatory Guidelines
     ICH (Q, S, E, M)
     WHO (WHO TRS) 
     EMA/EudraLex (EU Legislation)
     PICS
     USFDA
     UKMHRA
    Important Regulatory Authorities
     USFDA(USA), 
     MHRA(UK), 
     TGA(Australia), 
     CDSCO(India), 
     HEALTH CANADA(CANADA), 
     MCC(South Africa),
     ANVISA (Brazil) , 
     EMEA (European Union), 
     SFDA (China),
     NAFDAC(Nigeria), 
     MEDSAFE(Newzeland), 
     MHLW(Japan), 
     MCAZ(Zimbabwe), 
     SWISSMEDIC(Switzerland), 
     KFDA(Korea), 
     MoH (Sri Lanka) etc.
    Professional Organization for RA 
    REGULATORY AFFAIRS PROFESSIONAL SOCIETY

    THE ORGANIZATION FOR PROFESSIONALS IN REGULATORY AFFAIRS
    • Regulatory Affairs is a rewarding , intellectually 
    stimulating and highly regarded profession within 
    pharmaceutical companies.

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