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.
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