The results of research carried out by the WHO Prequalification Team: medicines (PQTm) indicated that manufacturers can benefit from participating in WHO prequalification in a number of ways. These benefits are not guaranteed and may take time — the time it takes an applicant or manufacturer to attain prequalification of a finished pharmaceutical product (FPP) or active pharmaceutical ingredient (API), for example — but they are worth considering when determining whether or not to submit an FPP or API for evaluation for prequalification. They may include:
increased sales or market access
- eligibility for international, donor-sponsored tenders for medicines
- improved capacity to manufacture products for entry into stringently-regulated markets
- increased potential to compete successfully for contract manufacture for local markets
- faster registration
improved image or brand
- status associated with producing quality-assured products
- enhanced image both externally and internally
reduced manufacturing costs
- due to improved capacity utilization
- lower variable/commercial operating costs
- development of human resources for ensuring and managing quality manufacture
- capacity to ensure quality manufacture across range of products
- new or increased capacity to meet stringent regulatory requirements.
Which manufacturers can participate?
Any manufacturer of an active pharmaceutical ingredient (API) or finished pharmaceutical product (FPP) may apply for prequalification of its product(s), provided that the API or FPP is eligible for prequalification. As of June 2019, 76 manufacturers from 29 countries had an FPP or FPPs listed on the WHO List of Prequalified Medicinal Products and 46 manufacturers from 6 countries had an API or APIs listed on the WHO List of Prequalified Active Pharmaceutical Ingredients. Fourteen manufacturers have both prequalified FPPs and APIs, meaning that 108 different manufacturers have a prequalified product or products. With respect to FPPs, applicants included both generic and innovator FPP manufacturers.
Information for manufacturers who wish to participate
The key section of this website for potential applicants who wish to participate in WHO medicines prequalification, and those already participating in WHO medicines prequalification are:
- Prequalification Pipeline — summarizes what has been prequalified already and what is currently under assessment
- WHO List of Prequalified Medicinal Products and WHO List of Prequalifed Active Pharmaceutical Ingredients — giving details of medicinal products (i.e. FPPs) and APIs that have been prequalified, including applicant and manufacturing site details
- FPPs and APIs Eligible for Prequalification — information on the FPP(s) or API(s) currently eligible for evaluation for prequalification
- Procedures and Fees — information on prequalification requirements for FPPs and APIs, be this for full assessment or for products that have already received approval from a stringent regulatory authority, as well as application procedures
- Post-prequalification Procedures — information on what an applicant must do to maintain prequalification status
- Prequalification Reports — WHO Public Assessment Reports describe the products that have been prequalified and WHO Public Inspection Reports describe the manufacturing sites and contract research organizations (and also the quality control laboratories) that have passed WHO inspection
- Guidance Documents — WHO guidelines underpin WHO medicines prequalification and define the requirements that must be met, WHO prequalification guidance offers manufacturers valuable direction with respect to specific aspects of prequalification and The International Pharmacopoeia gives quality specifications for selected pharmaceutical products, excipients and dosage forms
- Collaborative Procedure for Accelerated Registration — describing an innovative WHO procedure that offers manufacturers the opportunity to get their products onto markets more quickly
- Support to Manufacturers — describes the technical advice and technical assistance available to manufacturers to help them work towards prequalification of their FPP or API
- Market Information — with links to reports and sources that contain information (including prices and volume) about who is procuring what
- Key Contacts — the key persons who can be contacted regarding different aspects of medicines prequalification, or collaborative registration or technical assistance.
Before submitting an application for prequalification
Applicants should contact PQTm before submitting an application for evaluation of an API or FPP. A pre-submission meeting is compulsory for any applicant that is new to prequalification. PQTm is able to advise on all aspects of a submission — format, as well as dossier contents.
The guidance on pre-submission meetings outlines the items that can be covered in such meetings, irrespective of whether or not the applicant is new to prequalification. A good quality dossier will increase the likelihood that it will pass PQTm’s screening following submission. Furthermore, a good quality dossier is one of the most important determinants of time to prequalification.
PQTm can also make recommendations regarding organization of technical assistance if it considers that a manufacturer should work on a specific technical issue or problem area before application submission.
The Expert Review Panel (ERP)
Despite increasing demand from donors, WHO-prequalified or products approved by a stringent regulatory authority are not available on the market for all needed medicines. Procurers may therefore find themselves in the position of having to urgently procure products about which little is known in terms of quality risk. The Expert Review Panel (ERP) was created in 2009 to help procurers — such as the Global Drug Facility, the Global Fund to Fight AIDS, Tuberculosis and Malaria and UNFPA (United Nations Population Fund) — assess this risk. An independent advisory body of technical experts coordinated by WHO, it assesses the quality risks based on transparent criteria of FPPs that have not yet undergone stringent assessment. The results of its assessment are used to inform procurement decisions regarding time-limited procurement of the products assessed. To be eligible for ERP assessment, an FPP must generally be manufactured at a site that is compliant with Good Manufacturing Practices. Information about calls for submission of FPPs for ERP assessment can be found in the Market Information section.