Snapshot

The WHO Collaborative Registration Process: Accelerated Registration of Prequalified FPPs pathway has been developed by the World Health Organization of WHO.

This pathway can be used where The procedure can be used to support applications for national registration of any Finished Pharmaceutical Product (FPP) that has been assessed for WHO prequalification and prequalified..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Angola Armenia Azerbaijan Bangladesh Belarus Benin Bhutan Botswana Burkina Faso Burundi CARPHA-CRS Cameroon Cape Verde Central African Republic Chad Comoros Congo Congo, Democratic Republic of the Congo Cote D'Ivoire Eritrea Ethiopia Gabon Gambia Georgia Ghana Guinea Kazakhstan Kenya Kyrgyzstan Lao People's Democratic Republic Lesotho Liberia Madagascar Malawi Malaysia Maldives Mali Mauritania Moldova, Republic of Mozambique Namibia Nepal Nigeria Pakistan Papua New Guinea Philippines Rwanda Sao Tome and Principe Senegal Sierra Leone South Africa Sri Lanka Sudan Tanzania Thailand Timor-Leste Togo Turkey Uganda Ukraine Uzbekistan Yemen Zambia Zanzibar Zimbabwe

When relevant, the agency relies on prior decisions from WHO

Target time assessment is If the NMRA of the country in which registration of the prequalified FPP is sought agrees to apply the procedure to the product concerned, it commits to reaching its decision within 90 days of receiving access to the assessment and inspection information, as to whether it will register the FPP, and to communicate its decision to WHO and the applicant within a further 30 days. Regulatory time starts after a valid application for the registration according to the procedure has been received and access to the confidential information has been granted (whichever is the later) and continues until the date of decision on registration. The regulatory time does not include the time granted to the applicant to complete missing parts of documentation, provide additional data or respond on queries raised by NMRAs. It may not be possible for the NMRA to issue its decision regarding registration within 90 days. If this is the case, the NMRA must communicate to PQTm its justification for its delayed decision. If the NMRA fails to do so, PQTm will follow up with the NMRA, to investigate the situation and to agree on remedial actions..