Finished pharmaceutical products
WHO prequalification of a finished pharmaceutical product (FPP) provides assurance that the FPP meets international standards of quality, safety and efficacy.
There are two possible routes to FPP prequalification, each with specific submission procedures: full assessment and abbreviated assessment.
Full assessment of a multisource (generic) FPP, with an option to apply the active pharmaceutical ingredient master file (APIMF) procedure
This incorporates:
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assessment of pharmaceutical product data and information on safety, efficacy and quality submitted by the manufacturer, including product formulation, manufacture and test data and results
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inspection of FPP and active pharmaceutical ingredient manufacturing sites to verify compliance with WHO Good Manufacturing Practices
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inspection of clinical testing units or contract research organizations that performed clinical studies (trials) in relation to the product, to verify that compliance with WHO Good Clinical Practices and WHO Good Laboratory Practices was assured during those clinical trials.
Information supplied by stringent national regulatory authorities (SRAs) relating to the product may be taken into account for some elements of the assessment.
Assessment of a stringently-approved multisource (generic) or innovator product
WHO recognizes the scientific evaluation of FPPs that has been conducted by regulatory authorities that apply stringent standards to evaluating quality, safety and efficacy that are similar to those recommended and applied by WHO when evaluating products for prequalification. This recognition contributes to optimizing use of regulatory and manufacturers' resources.
Under assessment of a product that has already been approved by a stringent regulatory authority (SRA) the applicant shares relevant information with WHO such as the SRA assessment reports and inspection reports. WHO bases its decision to prequalify on the basis of this information. In such cases, the time to prequalification is generally much less than the time to prequalification of a product that undergoes full assessment.
WHO Model Dossier
The Model Dossier (MD) is an example medicine dossier. The product chosen for the MD is a prequalified solid oral product, levonorgestrel 0.75 mg tablets. However, the MD is intended to have general applicability across therapeutic areas and can be broadly useful, including for example to new drugs.
Note: To download the Model Dossier, you will be required to agree to our disclaimer and submit your contact information.
(Zip 52mb)
The Model Dossier (MD) is an example medicine dossier. The product chosen for the MD is a prequalified solid oral product, Levonorgestrel 0.75 mg tablets. However, the MD is intended to have general applicability across therapeutic areas and can be broadly useful, including for example to new drugs.
WHO requires that dossiers for generic medicines are submitted in ICH1 Common Technical Document (CTD) format, including completed modules 1-3 and 5, as well as various completed templates.
The MD includes the completed quality templates (QIS, quality information summary and QOS-PD, quality overall summary-product dossier) and the corresponding data expected in CTD Module 3 for the example product. In the MD, an active pharmaceutical ingredient master file (APIMF) is used to support the API data requirements. Therefore, the open part of the APIMF is included in Module 3 as required.
The MD is intended for the following purposes:
a) As a training tool for regulators: Without a real dossier that can be used as part of the training process, the training of regulatory assessors remains limited to a theoretical discussion. A real dossier would allow the training to be hands-on and include practical assessment exercises. However, proprietary considerations often make this impossible. The MD contains the full data set for Module 3 of the example product, with selected proprietary information redacted. The data package has the minimum redactions required for proprietary considerations, while still making the data usable for the purpose of training.
The MD is designed so that regulators can, during training exercises, apply their own standards and requirements to the assessment of the data.
b) As guidance for applicants: The MD can be used as guidance by applicants when preparing their dossier for submission to PQTm, in particular with respect to the contents of the Quality Information Summary (QIS) and Quality Overall Summary-Product Dossier (QOS-PD) templates (CTD Module 2.3), and the data to be included in the Module 3 sections (CTD Module 3.2). Applicants should understand, however, that each submission is unique and will be evaluated on a case-by-case basis. The current PQTm guidelines must always be consulted in order to understand the requirements for a given dossier. The current QIS/QOS-PD templates from this site should be used in the dossier submission.
c) As an example for organizations involved in harmonizing regulatory requirements: The MD may be used as a general reference when establishing harmonized data requirements for the quality templates and the data in Module 3 of a dossier.
This is a pilot project for which WHO is inviting feedback. Based on the feedback received, WHO may revise the MD and its intended use.
Use of the MD is subject to the Disclaimers.
Feedback on the MD and its usefulness is encouraged and should be sent to Dr M. Stahl, Team Lead, Medicines Assessments at stahlm@who.int. Please include in your feedback the type of use of the MD (training, preparation of dossier, etc.) and your experience (benefits, drawbacks).