The Prequalification Procedures and Fees section of this website is dedicated to enabling potential applicants to determine how, whether and what information they must compile in order to submit an application for WHO prequalification.
Who can participate in WHO prequalification?
Any manufacturer of active pharmaceutical ingredients (APIs) and/or finished pharmaceutical products (FPPs) can express an interest in having its API or FPP products evaluated by WHO, provided those products are eligible for assessment. FPPs eligible for evaluation include both generic and innovator FPPs, and FPPs that contain just one active ingredient or that combine several.
Medicines quality control laboratories (QCLs) that undertake chemical and microbiological (including bacterial endotoxins) testing of medicines are also eligible to apply for prequalification.
What are the steps of the prequalification process?
The following is a simplified overview of the prequalification process for APIs and FPPs.
- The manufacturer verifies that the API or FPP that it wants to submit for evaluation for prequalification is included in the relevant Invitation to Manufacturers to Submit an Expression of Interest for Evaluation.
- The manufacturer submits an application to WHO in accordance with the prequalification procedure for the product (either API or FPP).
- WHO screens the information submitted for evaluation for prequalification, using a screening checklist. This is an in-house list of dossier characteristics that need to be confirmed to be acceptable before a dossier is assigned a WHO reference number and accepted for full assessment. The checklist provides insight into what aspects are considered to be the key elements of an assessment of a generic FPP. The screening may lead to a request or requests for additional information.
- If the API or FPP has already been approved by a stringent regulatory authority, the applicant may choose to make a submission for abbreviated assessment
- Assessment of dossier and verification of compliance of the manufacturing (API and FPP) and clinical testing sites (i.e. contract research organizations) with relevant WHO good practices.
The process for prequalification of QCLs is similar to that for APIs and FPPs, consisting of the following steps:
- The QCL consults the Invitation to Quality Control Laboratories to Submit an Expression of Interest for Prequalification, to verify that it is eligible for prequalification.
- The QCL submits an application — which will include a laboratory information file — to WHO, in accordance with the prequalification procedure for QCLs.
- WHO reviews the laboratory information file (or quality manual). It may request submission of additional information and it may also stipulate inspection of the QCL.
Once an API, FPP or QCL has met prequalification requirements it is added to the relevant WHO list.
What happens when an API, FPP or QCL is prequalified?
APIs for which the API master file and manufacturing site(s) meet prequalification requirements, are included on the WHO List of Prequalified Active Pharmaceutical Ingredients, together with the applicant’s name, and corresponding product and manufacturing site details. Also, the manufacturer of each prequalified API is issued with a document known as a WHO Confirmation of Active Pharmaceutical Ingredient Prequalification. This document contains the accepted active ingredient specifications, and copies of the assay and related substances test methodology. It can be provided to interested parties, at the manufacturer’s discretion.
FPPs that are considered to have met prequalification requirements are included on the WHO List of Prequalified Medicinal Products, together with the applicant’s name, and corresponding product and manufacturing site details. In addition, for any FPP that underwent full (as opposed to abbreviated) assessment, a WHO Public Assessment Report (WHOPAR) and a WHO Public Inspection Report (WHOPAR), for any inspection that was conducted and concluded successfully, are posted on this website. The WHOPAR will summarize the assessment of the product information that was submitted in the product dossier. The WHOPIR(s) will provide the date, duration and scope of the inspection, and a summary of the observations and findings of the inspection(s).
Posting of the WHOPAR and WHOPIR(s) generally occurs some time after inclusion of the relevant product in the WHO List of Prequalified Medicinal Products. This is because their contents must be agreed with the manufacturer. This includes ensuring that proprietary information regarding the product, and any individual observations that were communicated in the full inspection report(s), have been excluded.
Prequalified QCLs are included in the WHO List of Prequalified Quality Control Laboratories, together with details of the type of analysis each carries out with respect to FPPs and/or APIs.