Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability

1. Introduction:

These guidelines provide recommendations to regulatory authorities when defining requirements for approval of multisource (generic) pharmaceutical products in their respective countries. The guidance provides appropriate in vivo and in vitro requirements to assure interchangeability of the multisource product without compromising the safety, quality and efficacy of the pharmaceutical product.

National regulatory authorities (NRAs) should ensure that all pharmaceutical products subject to their control conform to acceptable standards of safety, efficacy and quality, and that all premises and practices employed in the manufacture, storage and distribution of these products comply with good manufacturing practice (GMP) standards so as to ensure the continued conformity of the products with these requirements until they are delivered to the end-user.

All pharmaceutical products, including multisource products, should be used in a country only after approval by the national or regional authority. Regulatory authorities should require the documentation of a multisource pharmaceutical product to meet the following:

– GMP;

– QC specifications;

– pharmaceutical product interchangeability.

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Table of Contents

1. Introduction

2. Glossary

3. Documentation of equivalence for marketing authorization

4. When equivalence studies are not necessary

5. When equivalence studies are necessary and types of study required

6. In vivo equivalence studies in humans

7. Pharmacokinetic comparative bioavailability (bioequivalence) studies in humans