Guidelines on Submission of Documentation for a Multisource (Generic) Finished Product. General Format: Preparation of Product Dossiers in Common Technical Document Format. WHO Technical Report Series, No. 961, 2011, Annex 15
(2011; 12 pages)

Abstract

In its forty-fifth report, the World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations published the Procedure for prequalification of pharmaceutical products which 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.

The above-mentioned report 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 this report, when submitting an Expression of Interest (EOI) for product evaluation, the applicant should send to the WHO focal point (together with the other data requirements) a product dossier (PD), in the format specified in the WHO guidance documents on submitting product data and information.

Through the International Conference on Harmonisation (ICH) process, considerable harmonization has been achieved in the organization of the registration documents with the issuance of the common technical document (CTD) guideline (2-5). This recommended format in the CTD guideline for registration applications has become widely accepted by regulatory authorities both within and beyond the ICH Regions.

This document provides recommendations on the format and presentation for these types of PDs.

These guidelines are intended to:

  • assist applicants in the preparation of PDs for multisource products by providing clear general guidance on the format of these dossiers;
  • fully adopt the modular format of the CTD as developed by ICH; and
  • provide guidance on the location of regional information (Module 1) and other general data requirements.

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

 
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