Guidelines on registration requirements to establish interchangeability

The Committee noted that this document was a revision of an existing document. It adopted the document in principle, subject to the inclusion of any appropriate minor amendments resulting from comments received by 30 November 2005 (Armex 7). 

Subsequent to the recommendations made at the previous meeting of the Committee, the Secretariat took steps towards the revision of the published list of comparator products (published in WHO Technical Report Series, No. 902, Annex 11). The Committee noted that the updates received from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) had been included by the Secretariat and that the list was also compared with the WHO Model List of Essential Medicines. The list of comparator products had been circulated and comments were awaited by 30 November 2005. The Committee adopted the list, subject to any minor changes based on comments received, and recommended that  

The Committee acknowledged with thanks the cooperation of industry in the preparation of the list. 

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Guidelines on registration requirements to establish interchangeability of multisource (generic) pharmaceutical products (revision. Annex 7). Proposal to waive in vivo bioequivalence requirements for the WHO Model List of Essential Medicines, immediate release, solid dosage forms (Armex 8). 

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

The potential impact of the revised guidelines on registration requirements to establish interchangeability is that many of the medicines on the EML could become eligible for approval based on in vitro bioequivalence testing in accordance with the dissolution tests prescribed in Section 9 of the Multisource document ... 

Multisource (generic) pharmaceutical products guidelines on registration requirements to establish interchangeability. Geneva, World Health Organization, 2006 (WHO Technical Report Series, No. 937) Annex 7. 

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