Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product for the WHO Prequalification of Medicines Programme: Quality Part. WHO Technical Report Series, No. 970, 2012, Annex 4
(2012; 76 pages)


The Procedure for prequalification of pharmaceutical products outlines the procedure and considerations for the process undertaken by WHO in providing United Nations agencies with advice on the acceptability, in principle, of pharmaceutical products for procurement by such agencies. It states: "This activity of WHO aims to facilitate access to priority essential medicines that meet WHO-recommended norms and standards of acceptable quality."

As mentioned in WHO Technical Report Series, No. 961, in submitting an expression of interest (EOI) for product evaluation, the applicant should send a product dossier (PD) to the WHO focal point (together with the other data required), in the format specified in the WHO guidance documents on submitting product data and information.

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 for the Quality module of the registration documents with the issuance of the Common technical document (CTD) – quality (ICH M4Q) guideline (2). This format, recommended 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.

The current document provides recommendations on the quality information for active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs) that should be submitted to WHO to support PDs...

These guidelines are intended to:

  • assist applicants in the preparation of the Quality Module of PDs for multisource products by providing clear general guidance on the format of these dossiers;
  • fully adopt the modular format of the Common technical document – quality (M4Q) (2) as developed by ICH;
  • provide guidance on the technical and other general data requirements.

These measures are intended to promote effective and efficient processes for the development of these PDs by applicants and for the subsequent assessment procedures by WHO.

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