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

Republication of Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability, WHO Technical Report Series, No. 992, Annex 7 with a new Appendix 2

Background:

Following the publication of the Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability in 2015, it was noted that a text on equilibrium solubility experiments for the purpose of classification of active pharmaceutical ingredients (APIs) according to the Biopharmaceutics Classification System (BCS) would be a useful addition. The method for determination of equilibrium solubility was suggested to be added as an appendix to the above-mentioned guidelines.

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.

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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

8. Pharmacodynamic equivalence studies

9. Clinical equivalence studies

10. In vitro equivalence testing