Contract Research Organizations (CROs)

Products submitted to the Prequalification Programme are usually multisource (generic) products. In such cases, therapeutic equivalence (i.e. efficacy and safety) are generally demonstrated by performing a bioequivalence study, for example in a Contract Research Organization (CRO). In some CROs there have been findings of deficient and discrepant bioequivalence data, including non-compliance with WHO norms and standards with respect to Good Clinical Practices (GCP). These findings have been summarized in the » attached slides, which also highlight the reference documents used by the WHO GCP inspectors.

Additional Good Clinical Practice (GCP) guidance for Contract Research Organizations (CROs)

The Prequalification Programme was started in 2001 to assure medicinal products supplied for procurement meet WHO norms and standards with respect to quality, safety and efficacy. Specifically, it is a requirement that the submitted product dossier with all its necessary contents is assessed and found acceptable, and that the manufacturing site for the finished pharmaceutical product is inspected and found to comply with WHO Good Manufacturing Practices (GMP).

Products submitted to the Prequalification Programme are usually multisource (generic) products. In such cases, therapeutic equivalence (i.e. efficacy and safety) are generally demonstrated by performing a bioequivalence study, for example in a Contract Research Organization (CRO). In some CROs there have been findings of deficient and discrepant bioequivalence data, including non-compliance with WHO norms and standards with respect to Good Clinical Practices (GCP). For this reason it is now a prerequisite for prequalification of high-risk products (e.g. antiretrovirals, especially fixed-dose combination products) that - in addition to the abovementioned requirements - the Contract Research Organization (CRO) used by the sponsor for bioequivalence studies is inspected and found to comply with WHO Good Clinical Practices (GCP) and Good Laboratory Practices (GLP). CROs involved in the conduct of bioequivalence studies with products to be submitted for prequalification therefore need to ensure that they comply with the mentioned norms and standards to be prepared for such compulsory inspections.

The present guideline targets organizations conducting in vivo bioequivalence studies and highlights certain important aspects of the activities of such organizations. It does not replace other GCP or GLP guidelines mentioned in the document. The document should therefore be read in conjunction with those guidelines. It may be used as an additional guidance by CROs for the conduct of studies.

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