Why participate?

The results of research carried out by WHO 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

• increased capacity/skills

  • 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 a product, provided that the product in question is eligible for prequalification. Current applicants include both generic and innovator FPP manufacturers.

Information for manufacturers who wish to participate

The key sections 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 ― providing information about what FPPs are 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 specialized 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
• Risk–benefit Assessment ― describing procedures other than prequalification for assessing products and which can facilitate market entry for manufacturers
• 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 WHO before submitting an application for evaluation of an API or FPP. A pre-submission meeting is compulsory for all applicants who are new to WHO prequalification. WHO is able to advise on all aspects of a submission, including dossier format and contents. Evidently, a good-quality dossier at submission will increase the likelihood that it pass screening. Moreover, a good-quality dossier is one of the most important determinants of time to prequalification. 

Pre-submission meetings are also available to manufacturers who have already submitted products for prequalification.

The guidance below on pre-submission meetings outlines the items that can be covered in these meetings.

WHO 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 submission of an application.