Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product: Quality Part. WHO Technical Report Series, No. 986, 2014, Annex 6
(2014; 72 pages)


This document is technically and structurally inspired by the generic quality guidelines, WHO Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part, published in WHO Technical Report Series, No. 970, Annex 4. The resulting guidance document is proposed for wider use by national medicines regulatory authorities (NMRAs) throughout WHO regions. Through the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) process, considerable harmonization has been achieved on the organization of the Quality Module of registration documents with the issuance of the Common TechnicalDocument (CTD) ‒ Quality (ICH M4Q) guideline. This recommended format in the M4Q guideline for the quality information of registration applications has become widely accepted by regulatory authorities both within and beyond the ICH regions.

This document provides recommendations on the quality information for active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs) that should be submitted to NMRAs to support product dossiers (PDs). Alternative approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate scientific justification. It is also important to note that the NMRAs may request information or material, or define conditions not specifically described in this guidance, in order to adequately assess the quality of a pharmaceutical product.

These guidelines apply to PDs for multisource pharmaceutical products containing existing APIs of synthetic or semi-synthetic origin. For the purposes of these guidelines, an existing API is one that has been previously approved through a finished product by a stringent regulatory authority (SRA) or WHO. Fermentation, biological, biotechnological and herbal APIs are covered by other guidelines.

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