Collaborative Procedure Between the World Health Organization Prequalification of Medicines Programme and National Medicines Regulatory Authorities in the Assessment and Accelerated National Registration of WHO‑prequalified Pharmaceutical Products. WHO Technical Report Series, No. 981, 2013, Annex 4
(2013; 34 pages)

Abstract

In line with the Procedure for prequalification of pharmaceutical products, it aims at providing a convenient tool for NMRAs wishing to enhance their pre-marketing evaluation and registration system by taking advantage of the scientific assessment work conducted by WHO/PQP. The present procedure is complementary to the WHO/PQP collaboration procedure with NMRAs in inspection activities (http://www.who.int/prequal, "Inspections").

It is expected that enhanced collaboration and information exchange between NMRAs and WHO/PQP will benefit both partners. Subject to the agreement of the WHO prequalification holders concerned, NMRAs will gain access to assessment outcomes that are not in the public domain and that have been prepared in conformity with the WHO recommended standards on which the Procedure for prequalification of pharmaceutical products is based. Such reports will help NMRAs to make their decisions and may also assist in educating national regulatory staff. At the same time, feedback from NMRAs on the information and documentation received from WHO/PQP under the Procedure will allow WHO/PQP to improve its work and to ensure that the outcomes of prequalification assessments are relevant to NMRAs. As a consequence patients will benefit from this collaboration by gaining faster access to medicines which have been found acceptable in principle for procurement by United Nations agencies. Depending on available resources, participating authorities may be given the opportunity to participate in the assessment process and in inspections organized by WHO/PQP.

This collaborative procedure also benefits manufacturers of prequalified medicines through faster and better harmonized regulatory approvals in participating countries. This Procedure, when combined with the Collaboration Procedure with NMRAs in inspection activities, may also alleviate the burden of national inspections on manufacturers.

This collaborative procedure is limited to those pharmaceutical products that have been assessed and inspected by WHO/PQP in line with the procedures and standards available at www.who.int/prequal ("Information for applicants") and have been found to be acceptable in principle for procurement by United Nations agencies as listed in the List of WHO prequalified medicines available at www.who.int/prequal. It is not, however, applicable to medicines which have been listed as prequalified on the basis of approval by stringent regulatory authorities. Although it is expected that the Procedure will mostly serve to accelerate the assessment and registration of multisource (generic) pharmaceutical products, it is also applicable to any pharmaceutical product for which the safety and efficacy has been documented to WHO/PQP by the submission of preclinical and clinical data.

 
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