3. International drug regulatory agencies.pptx

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1. Pharmaceutical Regulatory Affairs Foreign Drug Regulatory Agencies Dr. Sm Faysal Bellah Associate Professor Department of Pharmacy SUB

2. Drug Regulatory Authorities A regulatory agency is a public authority or government agency . An independent regulatory agency is a regulatory agency that is independent from other branches or arms of the government. Regulatory agencies deal in the area of administrative law—regulation or rule making . Regulatory agencies are usually a part of the executive branch of the government. Their actions are generally open to legal review. Regulatory authorities are commonly set up to enforce S tandards and safety .

3. International Drug Regulatory Authorities

4. WHO The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health.

5. Guidelines The guidelines of ICH may be broadly categorized into four types- Q S E M -- Quality Guidelines --Safety Guidelines --Efficacy Guidelines --Multidisciplinary Guidelines Quality Guidelines Harmonisation achievements in the quality area include pivotal milestones such as the conduct of stability studies ,defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

6. - Its including following parameters: Q1-Stability Q2-Analytical Validation Q3-Impurities Q4-Pharmacopoeias ( eg : BP, USP, Ph.Eur ) Q5-Quality of Biotechnological products Q6-Specifications Q7-Good Manufacturing Practice Q8-Pharmaceutical development Q9-Quality risk management ( Deviation Management and CAPA, Change Control, Out of specification [OOS]) Q10-Pharmaceutical Quality System

7. B Safety Guidelines ICH has produced a comprehensive set of safety guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity . -Its including following parameters: S1-Carcinogenicity studies S2-Genotoxicity studies S3-Toxicokinetics and Pharmacokinetics S4-Toxicity Testing S5-Reproductive toxicology S6-Biotechnological products S7-Pharmacology studies S8-Immunotoxicology studies S9-Nonclinical evaluation for anticancer pharmaceuticals S10-Photosafety evaluation

8. C.Efficacy Guidelines The work carried out by ICH under the efficacy heading is concerned with the design, conduct , safety & reporting of clinical trials .It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics / genomics techniques to produce better targeted medicine . -Its including following parameters: E1 & E2 -Clinical safety E3- Clinical study reports E4-Dose-Response studies E5-Ethnic factors E6-Good Clinical Practice   E7, E8, E9, E10 & E11-Clinical trials E12-Guidelines for Clinical Evaluation by Therapeutic Category E13-Clinical Evaluation E14 & E15-Pharmacogenomics D. Multidisciplinary Guidelines Its including following parameters: MedDRA Terminology ( Medical Dictionary for Regulatory Activities) , Electronic Standards

9. FDA

10. Inspections are conducted by the following FDA Centres under the BIMO program: CDRH – FDA Centre for Devices and Radiologic Health. CDER – FDA Centre for Drug Evaluation and Research. CBER – FDA Centre for Biologics Evaluation and Research. CVM – FDA Centre for Veterinary Medicine.   35

11. Orange Book