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2003

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A brief idea aboutbpharmaceutical regulatory environment in US, UK and India

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2003

  1. 1. Overview of Regulatory EnvironmentOverview of Regulatory Environment in USA, Europe & Indiain USA, Europe & India Dijo Mathew JohnDijo Mathew John Pharm.D Post BaccalaureatePharm.D Post Baccalaureate
  2. 2. Need For Therapeutic Good RegulationNeed For Therapeutic Good Regulation  Protect health and safety of population.  By ensuring the safety, quality and efficacy of therapeutic goods covered under the scope of regulation.
  3. 3. Clinical Research Regulation in USAClinical Research Regulation in USA
  4. 4. Food & Drug AdministrationFood & Drug Administration  The US FDA is a scientific, regulatory and public health agency under the United States Department of Health and Human Services.  It is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate.  Comprised of several offices and centers.
  5. 5. Primary Responsibility of FDAPrimary Responsibility of FDA  For protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the- counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products and cosmetics.
  6. 6.  Agency scientists evaluate applications for new human drugs and biologics, complex medical devices, food and color additives, infant formulas and animal drugs.  The FDA monitors the manufacture, import, transport, storage and sale of about $1 trillion worth of products annually.
  7. 7. Centre for Drug Evaluation and ResearchCentre for Drug Evaluation and Research (CDER)(CDER) CDER is one of the centers of US FDA that Reviews NDAs and ANDAs for their safety and efficacy manages US cGMP regulations for pharmaceutical manufacturing Review advertising and promotion of drugs collects and analyses safety data about pharmaceuticals that are already on the market.
  8. 8. Selected regulations and guidance for drug studies  Code of Federal Regulations (CFR)  CFR Title 21: clinical trials related regulations. (revised frequently and published yearly):  Part 11: Electronic records  Part 50: Protection of human subjects  Part 54: Financial disclosure by clinical investigators  Part 56: Institutional Review Boards  Part 312: Investigational new drug application  Part 314: Applications for FDA approval to market a new drug
  9. 9. New Drug Approval Process at FDA 1. Sponsor/FDA Meetings (Pre-IND) 2. Submission of IND to FDA 3. Sponsor/FDA Meetings (End of Phase 2) 4. Accelerated Drug Review 5. Parallel Track 6. Clinical Hold Decision 7. Notification to Sponsor (i.e for deficiencies) 8. Sponsor/FDA Meetings (Pre-NDA) 9. New Drug Application 10. Final Meetings with Sponsor 11. Permission for marketing 12. Post marketing review
  10. 10. Clinical Research Regulation in Europe – TheClinical Research Regulation in Europe – The European Agency for the Evaluation ofEuropean Agency for the Evaluation of Medicinal Products (EMEA)Medicinal Products (EMEA)  Decentralized scientific body of the European Union  Protection and promotion of public and animal health through the evaluation and supervision of medicines for human and veterinary use.  Scientific opinions of the agency are prepared by 3 committees:  CPMP: medicines for human use  CVMP: veterinary medicines  COMP: designation of orphan medicines for rare diseases
  11. 11. Clinical Research Regulation in UK – Medicines &Clinical Research Regulation in UK – Medicines & Healthcare products Regulatory Agency (MHRA)Healthcare products Regulatory Agency (MHRA)  MHRA – competent authority of authority for the medical devices and the Licensing Authority for pharmaceuticals advised by Committee on Safety of Medicines (CSM)
  12. 12. Key Activities of MHRA  Regulating medical devices.  Licensing of medicines before marketing and subsequent variations.  Regulation of clinical trials.  Operating adverse incident reporting system for medical devices.  Issuing safety warning.  Responsibility for reporting, assessment and communications of defective medicines.
  13. 13.  Monitoring of medicines and acting on safety concerns after marketing.  Evaluating medical devices to inform purchasing and encourage safe use.  Managing the General Practice Research Database (GPRD).  Setting quality standards for drug substances through the ‘British Pharmacopoeia’.  Providing advice and guidance on medicines and medical devices.
  14. 14. Drug Regulatory System in IndiaDrug Regulatory System in India  Health is in concurrent list of Indian Constitution  It is governed by both central and state governments
  15. 15. Clinical Research Regulation in India –Clinical Research Regulation in India – Drug Controller General of India (DCGI)Drug Controller General of India (DCGI)  Legislation is enforced by Central Govt (Dept of Chemicals and Fertilizers, Ministry of Chemicals and Petrochemicals).  Drug Controller General of India (DCGI) under Central drug Standard Control Organization (CDSCO) has prime responsibility for regulating Clinical trials in India.  DCGI: matters related to product approval and standards, clinical trials, introduction of new drugs and import licenses for new drugs.
  16. 16.  Approvals for setting up manufacturing facilities, obtaining licenses to sell and stock drugs are provided by the State Governments.  2 drug organizations to exercise control over drugs:  Central Drug Standard Control Organization (CDSCO)  State Drug Control Organizations
  17. 17. Central Drug Standard Control OrganizationCentral Drug Standard Control Organization ((CDSCOCDSCO))  Controlling the quality of imported drugs.  Co-ordinating the activities of the States and advising them on matters relating to the uniform administration of the Act in the country.  Laying down Rules and ancillary provisions of Drugs Control and standards of drugs.  Controlling the quality of drugs moving in inter-state commerce jointly with Drug Control Organizations.  Granting approval to ‘New Drugs’ proposed to be imported or manufactured in the country.  Controlling the quality of drugs which are exported.  Arranging meetings of 2 statutory bodies, DTAB and DCC .
  18. 18.  Drugs Technical Advisory Board (DTAB): Technical experts and advises the Central and State Governments on all technical matters arising out of the enforcement of drug control.  Drug Consultative Committee (DCC): To ensure that the Drug Control measures are enforced uniformly in all States.  Genetic Engineering Approval Committee (GEAC): authority to approve rDNA pharmaceutical products. Assess the bio-safety/environmental product.
  19. 19. Clinical Trials Guidelines in IndiaClinical Trials Guidelines in India The guidelines that govern the conduct of Clinical trials in India include: • Schedule Y of Drugs and Cosmetics Act, 1940. • Ethical Guidelines for Biomedical Research on Human Subjects, 2000. • Good Clinical Practices, 2001.
  20. 20. Schedule Y of Drugs and Cosmetics Act, 1940Schedule Y of Drugs and Cosmetics Act, 1940 Requirement and guidelines on clinical trials for import and manufacture of new drug in India. Recommendations for carrying out Clinical Trials in India: • The clinical trials required to be carried out in the country before a new drug is approved for marketing depend on the status of the drug in other countries. • Phase III trials are usually required for the drugs which are already approved/marketed in the country of origin.
  21. 21. If the drug is not approved/marketed, trials are generally allowed to be initiated at one phase earlier to the phases of trials in other countries. For new drug substances (IND) discovered in other countries phase I trials are not usually allowed to be initiated in India, unless phase I data from other countries are available. If the drug is of unmet therapeutic need, such trials may be permitted even in the absence of phase I data from other countries.
  22. 22. For new drugs having potential for use in children, permission for clinical trials in the pediatric age group is normally given after phase III trials in adults are completed. However, if the drug is of value primarily in a disease of children, early trials in the pediatric age group may be allowed.
  23. 23. CDSCO
  24. 24. Application Requirements  Application for permission to conduct clinical trials is made to the office of DCGI in Form 44.  Permission to import drug may be obtained by applying in Form 12 for a test license.  Permission to carry out clinical trials with a new drug is issued in Form 11 along with a test license
  25. 25. Data requirements under schedule YData requirements under schedule Y
  26. 26. Thankyou…

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