Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products
1. Introduction:
In recent years the need for the regulation and assurance of quality of medicines has continued to increase. Large numbers of multisource (generic) medicines are being produced by many different companies and in different countries; this may result in different products. On a global level there is thus a need to address not only the quality, safety and efficacy of multisource products that are exported and imported, but also their possible interchangeability.
In light of the various approaches in scientific and regulatory environments, the feasibility of developing a system of international comparator products was considered in the past. This initiative led to the recommendations published in 2002 entitled, Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products (1). Since the guidance was published, the World Health Organization (WHO) Model List of Essential Medicines (EML) has been revised several times and many of the products originally listed are no longer marketed and/or available as indicated in the list, which means that the list of international comparators recommended by the WHO Expert Committee on Preparations for Pharmaceutical Specifications needs updating.
In view of the complexity of the list of comparators it was decided to prepare two new, separate, guidance documents: one on the selection of comparator products, including the general guidance on how to select comparator products, and the second one comprising the international list of comparator products. The aim was to facilitate the updating and maintenance process.
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Table of contents
WHO TRS (Technical Report Series) 992, 2015 Annex 8:
