Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.



Published on

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

Published in: Health & Medicine
  • Be the first to comment


  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…