WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 863 - Thirty-fourth Report
(1996; 200 pages) View the PDF document
Table of Contents
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related activities
View the document3. Simple test methodology
Open this folder and view contents4. Stability of dosage forms
Open this folder and view contents5. Good manufacturing practices for pharmaceutical products
Close this folder6. Legal and administrative aspects of the functioning of national drug regulatory authorities
View the document6.1. Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability
View the document6.2. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
View the document6.3. Guiding principles for formulating national drug legislation
View the document6.4. Role of the pharmacist
View the document6.5. Model legislative provisions to update national legal texts to deal with counterfeit drugs
View the document6.6. Additional guidance
View the document6.7. Training activities
Open this folder and view contents7. Quality assurance in the supply system
View the document8. Terminology
View the documentAcknowledgements
View the documentReferences
Open this folder and view contentsAnnex 1 - Guidelines for the graphic representation of chemical formulae
View the documentAnnex 2 - List of available International Chemical Reference Substances1
View the documentAnnex 3 - List of available International Infrared Reference Spectra
Open this folder and view contentsAnnex 4 - General recommendations for the preparation and use of infrared spectra in pharmaceutical analysis
Open this folder and view contentsAnnex 5 - Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms
Open this folder and view contentsAnnex 6 - Good manufacturing practices: guidelines on the validation of manufacturing processes
Open this folder and view contentsAnnex 7 - Good manufacturing practices: supplementary guidelines for the manufacture of investigational pharmaceutical products for clinical trials in humans
Open this folder and view contentsAnnex 8 - Good manufacturing practices: supplementary guidelines for the manufacture of herbal medicinal products1
Open this folder and view contentsAnnex 9 - Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability
Open this folder and view contentsAnnex 10 - Guidelines for implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Open this folder and view contentsAnnex 11 - Guidelines for the assessment of herbal medicines1,2
Open this folder and view contentsAnnex 12 - Guidelines on import procedures for pharmaceutical products
View the documentBack Cover
 

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

In adopting these guidelines (Annex 9), the Committee noted the wide consultation that had taken place following the suggestions made at its thirty-third meeting (11). It was pleased to note that the guidelines had already been adapted for local use by a number of WHO Member States and that positive feedback had been received especially with regard to the flexibility and clarity of the guidance. They were designed to allow a step-by-step approach tailored to the stage of development of a particular registration system and the needs and priorities of the national health authorities. The guidelines were intended to assist drug regulatory authorities and international organizations involved in the procurement of pharmaceutical products, and to provide manufacturers with an indication of the data required. The Committee recognized that these guidelines were a first step: they would need to be supported by training and advice on implementation. Use by international organizations would be crucial to their promulgation. It recommended that further consideration should be given to the feasibility of developing a system of international reference products.

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Last updated: May 3, 2013