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Comparative Study of Dossier Compilation & Submission Process of Drug Product in USA, Europe & India.
 

Comparative Study of Dossier Compilation & Submission Process of Drug Product in USA, Europe & India.

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Comparative Study of Dossier Compilation & Submission Process of Drug Product in USA, Europe & India.

Comparative Study of Dossier Compilation & Submission Process of Drug Product in USA, Europe & India.

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    Comparative Study of Dossier Compilation & Submission Process of Drug Product in USA, Europe & India. Comparative Study of Dossier Compilation & Submission Process of Drug Product in USA, Europe & India. Presentation Transcript

    • PRESENTED BY Devesh Sharma M.Pharm-DRA [email_address] PRESENTATION ON COMPARATIVE STUDY OF DOSSIER COMPILATION & SUBMISSION PROCESS OF DRUG PRODUCT IN USA, EUROPE & INDIA
    • CONTENTS
      • Aim & Objective of work
      • Introduction
      • Literature review
      • Regulatory guidelines for dossier submission in USA
      • Regulatory guidelines for dossier submission in Europe
      • Difference b/w EU & FDA
      • Drug product approval process in India
      • Comparative study of dossier submission process of drug product in USA, EU & India
      • Summary & conclusion
      • References
    • AIM & OBJECTIVE
      • Comparative study of dossier compilation &
      • submission process in USA, Europe & India
      • To understand the regulatory guidelines in
      • drug approval procedure
      • To understand the importance of regulatory
      • guidelines
      • Comparative study of regulatory guidelines of
      • FDA, EMEA & MHFW
      • Dossier is a file document submitted for the approval of drug product.
      • It is submitted in form of CTD.
      • CTD is a harmonized format (template) for presenting data in the ICH regions
      • Generic drug product is comparable to an innovator drug product-
        • In dosage form
        • Strength
        • Route of administration
        • Quality
        • Use etc
      INTRODUCTION
      • Generic drug approved under
      • ANDA submission (USA)
      • MAA submission (EU)
      • Generic drug applications are termed as “ Abbreviated ”
      • RLD- An approved drug product to which new generic versions are compared to show that they are bioequivalent.
    • Orange book -Approved drug product with therapeutic equivalence evaluations , published by the FDA (CDER) Hatch-Waxman act 1984 eliminates the costly clinical trial for approval of generic drugs. CDSCO is regulatory authority for the approval of new drugs proposed to be imported. (India)
      • Martin s. lipsky, in 2001, The drug approval process
      • Food and Drug Administration (FDA) is responsible for assuring
      • that foods and cosmetics are safe and that medicines and
      • medical devices are both safe and effective.
      • Welage L.S., in 2001, Understanding scientific issues
      • embedded in the generic drug approval process
      • Regulations regarding bioequivalence have been in place for
      • more than 20 years, controversies over bioequivalence continue
      • to arise.
      • Lionberger RA., in 2008, Opportunities for generic drug
      • development
      • FDA's critical path initiative documents have focused on the
      • challenges involved in the development of generic drugs.
      • Peters JR., in 2009, Generic drugs-safe, effective and
      • affordable dermotol
      • The history and evolution of the process for generic drug
      • evaluation and approval in the United States, with emphasis on
      • locally acting dermatologic products.
      REVIEW OF LITERATURE
      • Jaime R hornecker,in 2009, Generic drugs: history,
      • approval process and current challenges
      • According to the FDA, a generic drug is a product that compares
      • to the pioneer, or reference, drug product (usually a branded
      • drug) in dosage form, route of administration, strength, quality,
      • safety, and performance characteristics.
      • Filiz hinchal,in 2009, An introduction to safety issues in
      • biosimilars/follow-on biopharmaceuticals
      • Biopharmaceuticals are emerging global healthcare tools, which
      • promise to provide effective treatment of many serious and life-
      • threatening illnesses with their high specificity and activity; they
      • are considered the future of drug therapy.
      • Holmes CB , 2010, Use of generic antiretroviral agents and
      • cost savings in PEPFAR treatment programmes.
      • One of the biggest hurdles to the rapid scale-up of antiretroviral
      • therapy in the developing world was the price of antiretroviral
      • drugs (ARVs).
      • Chow sc , 2010, Statistical assessment of biosimilar
      • products
      • Biological products or medicines are therapeutic agents that are
      • produced using a living system or organism. Access to these life-
      • saving biological products is limited because of their expensive
      • costs.
      • Howland RH, 2010, Evaluating the bioavailability and
      • bioequivalence of generic medications
      • The U.S. Food and Drug Administration (FDA) is permitted to
      • approve generic versions of brand-name medications without
      • necessarily requiring that research be conducted to prove them
      • safe and effective, provided that a number of criteria are met.
      • The most important criterion is bioequivalence. Bioavailability
      • refers to the rate and extent to which the active ingredient is
      • absorbed from a drug product. Bioequivalence means that there
      • is an equivalent rate and extent of absorption of the same active
      • ingredient from two or more drug products.
    • REGULATORY GUIDELINES FOR DOSSIER SUBMISSION IN USA
    • Dossier is submitted in CTD format.
      • CTD format
      • Aim
      • To harmonize the structure and format of registration documentation.
      • Benefits
      • Complete, well-organized submissions
      • Facilitates electronic submissions
      • Easier analysis across applications etc.
    • Regional Admin Information Module-1 Nonclinical overview Clinical overview Clinical Summary Quality overall summary Quality Module-3 Nonclinical Studies Reports Module-4 Clinical Study Reports Module-5 The CTD Module-2 Not Part of CTD
      • The CTD is organized into five modules:
        • Module 1 is region specific.
        • Modules 2, 3, 4, and 5 are intended to be common for all regions.
      • Module 1. Administrative Information
        • Should contain documents specific to each region;
        • e.g. application forms or the proposed label for use in the region.
    • 1.1 Table of Contents of the Submission 1.2 Documents Specific to Each Region (for example, application forms,prescribing information,)
    • Module 2. CTD Summaries Begin with a general introduction to the pharmaceutical (its pharmacological class, mode of action, proposed clinical use. It contain 7 sections in the following order: 2.1 Common Technical Document Table of Contents (Modules 2-5) 2.2 CTD Introduction 2.3 Quality Overall Summary
    • 2.4 Non-clinical Overview 2.5 Clinical Overview 2.6 Non-clinical Written and Tabulated Summaries 2.7 Clinical Summary Module 3. Quality 3.1 Table of Contents of Module 3 3.2 Body of Data [Drug Substance, Drug Product & Regional information] 3.3 Literature References
    • Module 5. Clinical Study Reports 5.1 Table of Contents of Module 5 5.2 Tabular Listing of All Clinical Studies 5.3 Clinical Study Reports (BA/BE) 5.4 Literature References
    • REGULATORY GUIDELINES FOR DOSSIER SUBMISSION IN Europe
      • Pharmaceutical companies of EU are use three approval procedures to market their pharmaceuticals
      • A centralized or
      • A decentralized or
      • Mutual recognition
      • Centralized procedure-
      • Allows a pharmaceutical company to market its
      • pharmaceutical product in all 25 member states
      • Without having to obtain separate approvals from
      • each member state
    • Draft decision of the commission
      • Decentralized procedure-
      • An applicant can go directly to a national
      • marketing authority to obtain permission to
      • market its product in that member state and
      • Then seek to have other member states
      • accept the marketing approval of the first
      • member state.
    •  
    • Mutual recognition procedure (MRP)- Used in order to obtain marketing authorizations in several Member States where the medicinal product in question has received a marketing authorization in at least one Member State at the time of application.
    • DIFFERENCE b/w eu & fda
      • EU
      • Multiple agencies
        • European Medicines Evaluation Agency
        • (EMEA) – administrative organization
        • Committee for Medicinal Products for
        • Human Use (CHMP) of the EMEA – scientific
        • input
        • National Health Agencies
      • FDA
      • One agency
      • EU
      • Multiple registration procedures
        • Centralized
          • European Community
        • Decentralized/Mutual Recognition
          • At least 2 Member States
        • National
          • 1 Member State
      • FDA
      • One registration procedure
    • EU TSE /BSE study data is required Braille code is required on labeling FDA TSE /BSE study data is not required Braille code is not required on labeling
    • REGULATORY GUIDELINES FOR DOSSIER SUBMISSION IN INDIA
      • Drug & Cosmetic Act 1940 & Rules 1945
      • Regulates the import, manufacture,
      • distribution & sale of drugs &
      • cosmetics.
      • Schedule Y
      • Provides guidelines & requirements for
      • clinical trials
      • CDSCO
      • A licensing authority for approval of new drug
      • proposed to be imported
      • Head office located in New Delhi & functioning
      • under the control of directorate general of
      • Health services, MHFW, Govt of India.
      • DCGI
      • Responsible for approval of new drug &
      • Clinical trials to be conducted in India
      • Appointed by Central Govt of India
    •  
    • COMPARATIVE STUDY OF DOSSIER SUBMISSION PROCESS OF DRUG PRODUCT IN USA, EU, India
    • S.No. Requirements USA EU India A. ADMINISTRATIVE 1. Application ANDA MAA MAA 2. Debarment Certification Required NA NA 3 No. of copies 3 1 1 4 Approval time line 18 Month 12 Month 12 Month 5 Fees No Fees 10-20 Lakh 50,000 6 Presentation eCTD & Paper eCTD Paper B. FINISHED PRODUCT CONTROL 1. Justification ICHQ6A ICHQ6A ICHQ6A
    • S.No. Requirement USA EU India 2. Assay 90-100% 95-105% 90-110% 3. Disintegration Not required Required Required 4. Color Identification Not required Required Required 5. Water content Required Not Required Required C. MANUFACTURING & CONTROL 1. No. of batches 01 03 1 2. Packaging A min of 1,00,000 Units Not Required - 3. Process validation Not required at the time of submission Required Required 4. Batch size Min of 1,00,000 Units Min of 1,00,000 Units Not Specified
    • S.No. Requirement USA EU India D. STABILITY 1. No. of batches 01 02 01 2. Condition 25/60: 40/75 25/60: 40/75 30/35; 30/70 3. Date & Time of submission 3 Month Accelerate & 3 Month Long term 6 Month Accelerate & 6 Month Long term 6 Month accelerated & 3 Month Long term 4. Container orientation Inverted & Upright Do not address Do not address 5. Clause 21CFR Part 210 & 211 Volume4, EU guidelines for medicinal product ICHQ1F 6. QP Certification Not Required Required Required
    • S.No. Requirement USA EU India E. BIOEQUIVALENCE 1 CRO Audited by FDA Audited by MHRA CDSCO 2. Reserve sample 5 Times the sample required for analysis No such requirement - 3. Fasted/Fed Must be as per OGD recommendation NO such requirement As CDSCO recommendation 4. Retention of samples 5 Year from the date of filing the application No such requirement but usually followed 3 years from date of filing the application
      • SUMMARY
      • In this presentation we did individually study about the rule & regulations which are followed for drug approval process in USA, Europe & India.
      • Data in the dossier gives the answer of following questions:
      •  
      • What is the product?
      • Is the quality presented acceptable on grounds of
      • safety and efficacy?
      • Is the quality presented reproducible?
      • How long can the quality be maintained?
      • Quality must ensure consistency of safety and
      • efficacy during the shelf life of all batches
      • produced.
    • And in last we did the comparative study. This comparative study of dossier compilation given a brief idea about the difference in regulatory requirements for drug approval process among USA, EU & India.
      • Conclusion  
      • Significantly reduces the time and resources
      • needed to compile applications for registration
      • of human pharmaceuticals
      • Eases the preparation of electronic submissions
      • Facilitates regulatory reviews and
      • communication with the applicant by a standard
      • document of common elements
      • Simplifies exchange of regulatory information
      • between Regulatory Authorities
      •  
      • Provide for a scientifically sound means of
      • establishing the quality, safety and efficacy of
      • therapeutic products
      • Improve the transparency, predictability and
      • efficiency of the regulatory process
      • Contribute to reducing unnecessary regulatory
      • burden and promoting industry compliance
      • Promote bilateral and multilateral regulatory
      • communication and cooperation –common
      • regulatory platform
      • Level playing field good for export market
      •  
      • Generic drugs, website- www.wikipedia.org/wiki/generic-drug.
      • 2. CTD Guidelines map (ICH,EMEA AND FDA), website
      • www.reg- info.com/ctd-guidelines
      • 3. Drug price compitition & patent term restoration act of 1984,
      • website-http://www.cptech.org/ip/health/generic/hw.html
      • 4.180-day generic exclusivity, website-
      • ww.fda.gov/downloads/Drugs/.../Guidances/ucm079342.pdf
      •  
      • 5. Bioequivalence and Generic Medicines Introduction, website-
      • www.egagenerics.com/doc/zanen-biogenerics.pdf
      • 6. Introduction - European Agency for the Evaluation of
      • Medicinal products, website- www.emea.europa.eu/docs/en_GB/...library/.../WC500074880.pdf
      REFERENCE
    • 7. EMEA and Overview of the Centralised Procedure, website- www.who.int/entity/vaccine_research/diseases/influenza/Celis.pdf 8. Matin s.lipsky,lisa k. sharp, The drug approval process, Jabfp, sep-oct 2001,vol 14(5) 9. Welage LS kinking dm,ascione FJ, gaither CA. Understanding scientific issues embedded in the generic drug approval process,2001.feb- may04(5);114-30. 10. Lionberger RA., FDA critical path- initiatives, Opportunities for generic drug development.AAPS J.2008, 10(1): 103-9, Epub2008 feb20. 11. Peters JR,hixon DR, conner DP, davit BM, catterson DM, parise CM generic drugs-safe, effective and affordable dermotol ther.2009 may-jun,22(3);229-40 12. Jaime R hornecker, Generic drugs: history, approval process and current challenges , US pharm2009,34(6),26-30
    • 13. Filiz hinchal, An introduction to safety issues in biosimilars/follow-on biopharmaceuticals, Jmed cbr 7,1 sept. 2009 14. Holmes CB, coggin W,jamiesn D mihm H,rrancn R,savio P,Hope M,ryan C,moloney-kitts M,goosby EP, dybul M, use of generic antiretroviral agents and cost savings in PEPFAR treatment programmes. JAMA 2010 jul21,304(3) 313-20. 15. Chow sc lio.jp, Statistical assessment of biosimilar products. J.bio pharm stat2010 Jan, 20(1); 10-30. 16. Howland RH, Evaluating the bioavailability and bioequivalence of generic medications, J. psychosocial nursing and mental health serv.2010jan, 48(1) 17. Submitting Marketing Applications According to the ICH-CTD Format - General Considerations, website- http://www.fda.gov/RegulatoryInformation/Guidances/ucm129703.htm
    • 18.Revision History Module 1 Administrative informationwebsite- www.fda.gov/downloads/Drugs/.../UCM163175.pdf 19.FDA Debarment List (Drug Product Applications), website- www.fda.gov/ICECI/.../FDADebarmentList/default.htm 20. Guidance for Industry - FDA, www.fda.gov/.../Drugs/.../FormsSubmissionRequirements/ElectronicSubmissions/UM163188.pdf 21. ICH Guideline: The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality - M4Q; Quality Overall Summary of Module 2, Module 3: Quality,:http://www.ich.org
    • THANK YOU