International Drug Regulatory Affairs 1 Regulatory

Transcript:International Drug Regulatory Affairs 1 Regulatory:
International Drug Regulatory Affairs 1 Regulatory structure The pharmaceutical industry is one of the highly regulated industries with various structures of drug regulation ▫ Drug laws ▫ Drug regulatory agencies ▫ Drug evaluation boards ▫ Quality control laboratories ▫ Drug information centers 2 What is the need? Drug laws provide the basis for drug regulation Regulatory tools such as standards and guidelines equip authorities with the practical means of implementing those laws Regulatory Agencies monitor the implementation of these laws 3 Regulatory Scenario Regulated Markets Emerging Markets US Canada EU-27 states Japan Australia New Zealand Latin America Eastern Europe CIS Africa Asia Pacific Gulf countries 4 Regulatory Agencies 5 Obstacles Pharmaceutical, Non-clinical and Clinical issues emerge in all stages of development Regulatory guidelines problems encountered Language barrier Bureaucracy Political environment don’t always address 9 Registration Procedure of Drugs for International Marketing 10 Drug Approval Process A regulatory process by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market 11 Various Stages Application to conduct clinical trials Conducting clinical trials Application to marketing authorization of drug Post-marketing studies 12 13 14 Vendor Selection Approved API Excipients Packing Material Plant inspection API Plant Inspection BE studies approved CRO Test, Import & Manufacturing License Patent/ development Strategy BE Strategy Finished Product Development Dossier Writing Regulatory Filing to Authorities Dossier Evaluation Product Approval Common Technical Document (CTD) 16 Required for generics and New Drug Required for generics and New Drug. For generics summary on Quality part only required Summarizes Module 3, 4 and 5 Provides abstract of documents provided in the whole application Required for generics and New Drug Documents related to Chemistry, manufacturing and Control of both Drug Substance and Drug Product Data on pharmacologic, pharmacokinetic, and toxicological evaluation of the pharmaceutical product Not required for generics Critical assessment of the clinical data and related reports Generics require only BE study Consists of documents like Application form, legal documents (GMP, Licences etc.), labelling etc. 17 Accelerated and Intermediate Testing Conditions ICH Stability Zones Long Term Testing Conditions COUNTRY SPECIFIC GUIDELINES 18 Regulatory Agency Food & Drug Administration Main consumer watchdog is FDA's Center for Drug Evaluation in this system and Research (CDER) 19 Laws, Regulations, Policies & Procedures The Federal Food, Drug, and Cosmetic Act (1938) ▫ With numerous amendments it is the most extensive law of its kind in the world Code Of Federal Regulations (CFR) ▫ Section 21