WHO TRS (Technical Report Series) 902, 2002 Annex 11: pdf

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WHO TRS (Technical Report Series) 902, 2002 Annex 11: Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products

Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products

Introduction:


This annex provides a list of comparator products for equivalence assessment of interchangeable multisource (generic) products. The information on comparator pharmaceutical products was collected by the Secretariat from drug regulatory authorities and pharmaceutical companies. The list has been drawn up to assist regulatory authorities and pharmaceutical companies in deciding on appropriate comparator products in the context of multisource (generic) marketing authorization. The information could also be used for drug procurement purposes. Where the comparator pharmaceutical product is not clearly defined, criteria are suggested that are provided in a decision tree format (see Figure 1). This permits the selection of a comparator pharmaceutical product. 


The guidelines on registration requirements to establish interchangeability of multisource (generic) pharmaceutical products published by WHO (1) state that multisource products must satisfy the same standards of quality, safety and efficacy as those applicable to the corresponding innovator product. They recommend that quality attributes of a multisource product should be tested against the innovator product for which interchange is intended. 


See below pdf for complete guidelines



WHO TRS (Technical Report Series) 902, 2002 Annex 11: pdf

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