It is hoped that both guidelines will support the objectives of the Prequalification Programme, a United Nations program managed by the WHO that aims to make priority medicines available to those who need them. The medicines should meet WHO-recommended norms and standards of acceptable quality.
Guideline on submission of documentation for a multisource (generic) finished pharmaceutical product (FPP): Preparation of Product Dossiers (PDs) in CTD format
This guideline provides recommendations about the format and presentation of a generic pharmaceutical PD, and presents the agreed upon common format of a well-structured CTD.
In the introduction to the guideline, the WHO explains that a common format will “significantly” reduce the time and resources needed to compile such PDs, as well as ease the preparation of electronic submissions. It will also make the exchange of regulatory information between national medicine regulatory authorities and the WHO much simpler.
The guideline will apply to PDs for generic pharmaceutical products containing existing APIs (either synthetic or semi-synthetic in origin) and their corresponding finished pharmaceutical product
Guideline on submission of documentation for a multisource (generic) FPP: Quality Part
This quality guideline is more extensive than previous guidelines; however, the WHO claims this is not indicative of an increase in requirements. The guideline offers recommendations on the quality information for APIs and FPPs that should be submitted to the WHO to support PDs.
According to the WHO, the guideline has been updated to reflect current requirements and how these should be met. In some instances, there has also been a reduction in requirements; for example, there is a reduced requirement for the number of FPP batches required to establish the shelf-life for both complicated FPPs (reduced from a minimum of three pilot batches to two pilot batches) and uncomplicated FPPs (reduced from a minimum of three pilot batches to one pilot batch and a second batch that may be smaller).
Additionally, there are reduced requirements for the development and process validation for “established” generic products that have been marketed by the applicant for at least 5 years, with either 10 batches produced in the past year or 25 batches produced in the past 3 years.
Both guidelines have been provisionally accepted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations. They will be implemented on a pilot basis in the Prequalification Programme where they will help the WHO to list pharma products of acceptable safety, efficacy and quality in the interest of public health.