The World Health Organisation (WHO) is reviewing the draft guidelines for the scientific evaluation of finished pharmaceutical products (FPPs) by regulatory authorities which apply similarly stringent standards for quality, safety and efficacy as those recommended by it. It is now gearing up to release the final guidance by September this year.
The draft guideline which was issued for comments from the industry in May this year calls for a stringent regulatory authority (SRA) which is a member of the International Conference on Harmonization (ICH) to agree sharing information on an FPP with WHO.
Products that received US FDA tentative approval or positive opinions under Article 58 of European Union Regulation (EC) No. 726/2004 or the Canada S.C. 2004, c. 23 (Bill C-9) procedure, are not within the scope of this guide. Such products could be co-listed on the WHO list of prequalified products in accordance with mutual agreements with these regulators.
Following this, the WHO would consider such FPP for inclusion in the list of its prequalified products, as and when information about such a product becomes available.
Therefore these guidelines apply to both innovator and multi-source (generic) FPPs approved by SRAs, said WHO. For the prequalification of the FPPs, now WHO has called to make 11 submissions while seeking for the prequalification of finished pharmaceuticals. These include: a statement indicating that the information submitted is correct and confirming for the prequalification of the FPP which includes the composition/ formulation, strength, manufacturing, specifications, packaging, product information. A copy of the marketing authorization issued by the reference SRA and the current WHO-type certificate of a pharmaceutical product issued and fully completed. The latest SRA approved product information which includes the summary of product characteristics (SmPC), or an equivalent thereof, the patient information leaflet (PIL) and the labeling would also need to be submitted. A list of the SRA-approved manufacturers of the FPP, including manufacturers of intermediates, primary packaging sites and release-testing sites, with the physical address of the manufacturing sites.
Other submissions to be enclosed are a list of the SRA-approved manufacturers of the active pharmaceutical ingredients (API) used in the manufacture of the FPP, with the physical address of the manufacturing sites. A public assessment report, such as the Scientific Discussion of the European Public Assessment Report (EPAR), issued by the reference SRA.
The WHO also has called for assessment reports issued by the reference SRA and that are not publically available may be requested. A tabular listing of the batches manufactured for the market of the reference SRA’s region or country since approval, but not exceeding the last five years. The working document QAS/13.531 include at least the batch number, batch size (number of units), date 105 of manufacture and pack type/size. This will be along with a copy of the last product quality review (PQR). It must also have details of the sample of the product in market packaging. It should be provided with the submission to enable visual inspection thereof. The applicant must also attach the respective certificate of analysis. Further, WHO also requires a copy of the currently approved FPP specifications of shelf-life with the analytical test procedures.
WHO has insisted that all the submissions should be made in English, which includes translations of product information and other documents to be made available as hard copies and electronic formats. The English translations, should also be submitted as word files.