Introduction to Pharmaceutical Regulatory Affairs.pptx

Pharmaceutical regulatory affair is the interface between pharmaceutical industry and the regulatory bodies across the world.

1. REGULATORY AFFAIRS AND IMPORTANT TERMS USED IN REGULATORY AFFAIRS By: Srishti Gupta M. Pharm (Pharmaceutics)

2. Content Pharmaceutical regulatory affairs Important Terms Related To Regulatory Affairs Master formula record Drug master file Distribution record Generic Drugs New Drug Application Abbreviated New Drug Application Common Technical Document Clinical Trials Pharmacovigilance Investigator Brochure Investigation Medicinal Products Dossier

3. Important Terms Related To Regulatory Affairs Master Formula Record A Master Formulation Record (MFR) is a detailed document that describes how to prepare a drug product. It's a crucial part of regulatory compliance and process control in the pharmaceutical industry. The MFR is prepared by the research and development team and used as a reference standard for manufacturing personnel. It ensures consistency, accuracy, and quality control in the production process.

4. Drug Master File Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.

5. Distribution Record Distribution records are written data related to distribution of drug products from manufacturer to distributors. Distribution records must be constructed and procedures established to facilitate recall of defective product.

6. Generic Drugs A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire.

7. New Drug Application New Drug Application (NDA) is a type of application in which a pharmaceutical manufacturer or its agent requests permission from the U.S. Food and Drug Administration (FDA) for a license to market a drug for one or more specified indications.

8. Abbreviated New Drug Application An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.

9. Common Technical Document The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond.

10. Clinical Trials A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.

11. Pharmacovigilance Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use.

12. Investigator Brochure An Investigator's Brochure (IB) is a compilation of the clinical and non-clinical data on the investigational medicinal product or products which are relevant to the study of the product(s) in humans.

13. Investigation Medicinal Products Dossier An Investigational Medicinal Product Dossier (IMPD) contains data on the quality, production and control of the medicinal product being researched.