MPY204: PMRA Drug Regulatory Affairs-II (International Legislation) Syllabus

MPY204: PMRA Drug Regulatory Affairs-II (International Legislation)

Regulatory Agencies : Requirements of cGMP with specific reference of USFDA (21 CFR part 210 and 211), European Medicines Agency (EMEA) guidelines. Overview of GMP guidelines with specific reference of World health organization (WHO), Medicines and Healthcare products Regulatory Agency (MHRA), Medicines control council (MCC), Therapeutic goods administration (TGA) and ANVISA brazil guidelines.

Product Registration : Requirements for registration of pharmaceutical products into USA with emphasis on para I, II, III & IV filing. Preparation of documents for approval of IND, NDA, ANDA, BLA applications and export registration (USFDA 21 CFR part 310, 312, 314, 320). Preparation of dossier of Drug product and Drug master file.Biowaivers. Understanding the FDA 505(b)(2) Regulatory Approval Pathway, Hatch-Waxman act. Regulatory requirements good laboratory practice in US (USFDA 21 CFR part 58)

ICH Guidelines : with specific reference to stability, analytical validation, impurities, pharmacopeias, specification, quality risk management and pharmaceutical development. Preparation of Common technical document (CTD) as per ICH guidelines, electronic documentation and e-filing (e-CTD).

Industrial Guidelines : Guidance for Industry: IR/ MR Solid Oral Dosage Forms Scale - Up and Postapproval Changes (SUPAC)-Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation 

Guidance for Industry: Sterile/Non Sterile Semisolid Dosage Forms Scale - Up and Postapproval Changes (SUPAC)-Chemistry, Manufacturing and Controls, In Vitro Release Testing, and In Vivo Bioequivalence Documentation

Guidance for Industry : Dissolution testing of immediate release solid oral dosage forms.

Guidance for Industry : Extended release oral dosage forms: Development, evaluation and

application of In Vitro/In Vivo Correlations.

Guidance for Industry : Waiver of In Vivo Bioavailability and Bioequivalence Studies for

Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification

System

Practicals Related to Drug Regulatory Affairs-II (International Legislation)

1. Comparison of dissolution profiles and calculation of F1 and F2 values of tablets of

innovator/standard and generic manufaturers.

2. Comparison of In-vitro release and calculation of F1 and F2 values of semisolid

preparations of innovator/standard and generic manufaturers.

3. IVIVC –through various techniques

4. Preparation dossier of a pharmaceutical product.

5. Experiments to find out the BCS class of pharmaceuticals

Books and References Recommended:

1. Willing, Tuckerman and Hitchings, Good Manufacturing Practices for Pharmaceuticals

2. www.fda.gov

3. www.emea.europa.eu

4. www.picscheme.org