AN OVERVIEW ON REGULATORY AFFAIRS. pptx
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PPT on overview of regulatory affairs
AN OVERVIEW ON REGULATORY AFFAIRS. pptx
- 2. LIST OF CONTENTS Introduction Historical overview of Regulatory Affairs Regulatory authorities Role of Regulatory affairs department Responsibility of Regulatory Affairs Professionals
- 3. INTRODUCTION • Regulation and regulatory Affairs – Regulation involves extensive evaluation of a particular drug product to ensure protection of public health, promotion of the product, Drug registration, marketing authorization, import and distribution, pharmacovigilance. – Regulatory Affairs is a comparatively new profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
- 4. INTRODUCTION • Regulatory Affairs is a unique mixture of science and management to achieve a commercially important goal within a drug development organization. – Regulatory Affairs takes care of Development plan, supervising-writing / reviewing and assembling and submission management. – They give strategic and technical advice at the highest level in their companies, right from the beginning of the development of a product, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole.
- 5. BRIEF HISTORY OF FEDRAL FOOD DRUG AND COSMETIC ACT • 30th August 1880: Law prohibiting transportation of adulterated or unwholesome food, drugs or liquor. • 1906: Congress passed Wiley Act(Pure Food and Drug act) to prevent the manufacture, sale or transportation of adulterated or misbranded or poisonous or deleterious food, drug, medicine or liquors and their traffic therein. • 1912: amendment to prohibit any false claim/statement regarding of curative and any therapeutics effect on labelling of drugs. • June 27, 1938: Present act: – required pretesting of new drugs before marketing. – Dropped the concerns related to liquor. – For any new drug: NDA should be filed. – Label • Should state name and quantity of every ingredient whether active or inactive • False or misleading therapeutic claims were actionable until fraudulent intent • Manufacture and sale of medical devices was included. • Factory inspections by government to ensure compliance. • Cosmetics were included.
- 6. GENERATION OF VARIOUS REGULATIONS • Major incidences made us to understand that rules and regulations are required to prove safety along with efficacy of drug. Such incidences are as follows: - YEAR ACT REASON 1902 Biologics Control Act Diphtheria Epidemic 1906 Pure Food and Drugs Act Publication of The Jungle by Upton Sinclair 1938 Food Drug and Cosmetic Act Elixir of Sulfanilamide 1962 Kefauver- Harris Amendments Thalidomide: Drug Efficacy alongwith safety. 1976 Medical Device Amendments Dalkon Shield (contraceptive :IUD) 1990 Safe Medical Devices Act Bjork-Shiley Heart Valves
- 7. CHRONOLOGICAL EVALUATION OF R.A S.No YEAR CONTENT 1 1540 England: Manufacture of medicines were subjected to supervision under “Apothecaries Wares Drugs and Stuffs Act” 2 1581 First Pharmacopoeia: Spanish Pharmacopoeia 3 1618 The London Pharmacopoeia 4 1938 Introduction to Fedral Food, Drugs and Cosmetics Act 5 1940 & Drugs and cosmetics Act 1940 & Rules 1945 1945 6 1962 Drug amendment act of 1962(Drug efficacy and cGMP Compliance) 7 1963 Committee on safety of Drugs was established 8 1964 Yellow Card scheme (UK after Thalidomide disaster w.r.t. adverse effects) 9 1975 European community(laws regarding medicinal pdts.: analytical, pharmaotoxicological, testing protocols and action related to med. Pdts.) 10 1989 ICDRA organized by WHO 11 1990 ICH 12 1993 EMEA
- 8. GOALS OF REGULATORY AFFAIRS AS PROFESSION • Protection of human health • Ensuring safety, efficacy and quality of drugs • Ensuring appropriateness and accuracy of product information
- 9. ROLES OF REGULATORY AFFAIRS PROFESSIONALS • Act as a liaison with regulatory agencies • Preparation of organized and scientifically valid NDA, ANDA,INDA,MAA(Marketing authorization application),DMF (Drug master file) submissions • Ensure adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations and laws • Providing expertise and regulatory intelligence in translating regulatory requirements into practical workable plans • Advising the companies on regulatory aspects and climate that would affect their proposed activities • Apart from the above main roles, there are various other roles which Regulatory Affairs professionals play.
- 10. WHAT WORK IS DONE IN REGULATORY AFFAIRS DEPARTMENT? • A new drug/generic drug manufactured by a pharmaceutical company just cannot be released into the market for human use. • Here the Regulatory Affairs Department comes into play. • Regulatory Affairs Department of a pharmaceutical company files all the information related to the development, manufacture, control, stability studies, packing, labeling , safety and efficacy studies of drugs with the Regulatory agencies in a prescribed format as ANDA/NDA/MAA/DMF etc. • The Regulatory agency reviews the information provided in accordance with regulations, guidelines and if they are satisfied with information provided, approval will be granted for marketing of the drug by pharmaceutical companies for human use.
- 11. QUALITIES OF A GOOD RA PROFESSIONAL • Authoritative Team Player Decisive Resourceful Good Communication Skill Analytical Skill- Ability to evaluate the strengths and weakness of the technical and legal options open to a company. Good Informational Technology skills Negotiating Skills Able to reapply scientific and regulatory principles Ability to work with other disciplines Flexible- Always willing to learn.
- 12. RESPONSIBILITIES OF REGULATORY AFFAIRS DEPARTMENT • Keep in touch with international legislation, guidelines and customer practices • Keep up to the date with a company’s product range • Ensure that a company’s products comply with the current regulations. • The Regulatory Affairs professional’s job is to keep track of the ever- changing legislation in all the regions in which the company wishes to distribute its products. • They also advise on the legal and scientific restraints and requirements, and collect, collate, and evaluate the scientific data that their research and development colleagues are generating. • Formulate regulatory strategy for all appropriate regulatory submissions for domestic, international and/or contract projects.
- 13. RESPONSIBILITIES OF REGULATORY AFFAIRS DEPARTMENT • Coordinate, prepare and review all appropriate documents for example dossier and submit them to regulatory authorities within a specified time frame in conjugation with the organization. • Prepare and review of SOPs related to RA. Review of BMR, MFR, change control and other relevant documents. • Monitor the progress of all registration submission. • Maintain approved applications and the record of registration fees paid against submission of DMF’s and other documents. • Respond to queries as they arise, and ensure that registration/ approval are granted without delay. • Impart training to R&D, Pilot plant and RA Team members on current regulatory requirements.
- 14. RESPONSIBILITIES OF REGULATORY AFFAIRS DEPARTMENT • Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance. • Manage review audit reports and compliance, regulatory and customer inspections. • Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are also placed upon the claims which can be made for the product on labeling or in advertising. • Have a duty to provide physicians and other healthcare professionals with accurate and complete information about the quality, safety and effectiveness of the product.
- 15. APPROVED REGULATORY BODIES AND AGENCIES COUNTRY USA UK REGULATORY AGENCY Food and Drug Administration (FDA) Medicines and Healthcare Products Regulatory Agency (MHRA) Australia India Canada Europe Therapeutic Goods Administration (TGA) Central Drug Standard Control Organization (CDSCO) Health Canada European Medicines Agency (EMEA) Denmark Danish Medicines Agency Costa Rica Ministry of Health New Zealand Medsafe - Medicines and Medical Devices Safety Authority Sweden Medical Products Agency (MPA) Netherlands Medicines Evaluation Board
- 16. APPROVED REGULATORY BODIES AND AGENCIES COUNTRY Ireland Italy Nigeria Ukraine Singapore REGULATORY AGENCY Irish Medicines Board Italian Pharmaceutical Agency National Agency for Food and Drug Administration and Control (NAFDAC) Ministry of Health Centre for Pharmaceutical Administration Health Sciences Authority Department of Health: Pharmaceutical Services Ministry of Health Medical Products Agency (MPA) Ministry of Public Health State Food and Drug Administration Hong Kong Paraguay Sweden Thailand China Germany Federal Institute for Drugs and Medical Devices MADHU VERMA 16
- 17. APPROVED REGULATORY BODIES AND AGENCIES COUNTRY Malaysia Pakistan REGULATORY AGENCY National Pharmaceutical Control Bureau,Ministry of Health Drugs Control Organization, Ministry of Health South Africa Medicines Control Council MADHU VERMA 17 Sri Lanka SPC,Ministry of Health Switzerland Swissmedic , Swiss Agency for Therapeutic Products Uganda Uganda National Council for Science and Technology (UNCST) Brazil Agencia Nacional de Vigiloncia Sanitaria (ANVISA ) Japan Ministry of Health, Labour & Welfare(MHLW)
- 18. MAJOR REGULATORY AUTHORITIES S.NO COUNTRY REGULATORY AUTHORITY 01. INDIA Central drug standard control organization (CDSCO) Drug controller general of India (DCGI) 02. U.S US FDA 03. U.K Medicines and health care products regulatory agency (MHRA) 04. AUSTRALIA Therapeutic Goods Administration ( TGA) 05. CANADA Health Canada 06. SOUTH AFRICA Medicines control council(MCC)
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