Snapshot

The WHO Collaborative Registration Procedure: Finished Pharmaceutical Products assessed and approved by SRAs pathway has been developed by the World Health Organization (WHO) of WHO.

This pathway can be used where This procedure applies to any FPP (innovative medicines, vaccines, and biotherapeutics, as well as generics and similar biotherapeutics), as far as the product has been previously assessed and/or approved by an SRA and where a positive scientific opinion (including EU-M4all opinions) exists and can be shared with other NRAs worldwide. Like the procedure for prequalified products, this procedure facilitates the sharing of non-publicly available assessment, and inspection reports, from participating “SRA” and interested NRAs..

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 Bangladesh Benin Bhutan Botswana Brunei Darussalam Burkina Faso Burundi CARPHA-CRS Cameroon Cape Verde Central African Republic Chad Comoros Congo Congo, Democratic Republic of the Congo Cote D'Ivoire El Salvador Eritrea Ethiopia Gabon Gambia Georgia Ghana Guinea Jordan Kazakhstan Kenya Lao People's Democratic Republic Lesotho Liberia Madagascar Malawi Malaysia Maldives Mali Mauritania Montenegro Mozambique Namibia Nepal Niger Nigeria Pakistan Papua New Guinea Paraguay Philippines Qatar Rwanda Sao Tome and Principe Senegal Serbia Sierra Leone South Africa Sri Lanka Tanzania Thailand Timor-Leste Togo Turkey Uganda Ukraine Yemen Zambia Zanzibar Zimbabwe

When relevant, the agency relies on prior decisions from Algeria Argentina Armenia Australia Azerbaijan Brazil Canada China Colombia Cuba EU-EMA Egypt India Indonesia Iran, Islamic Republic of Israel Japan Jordan Kazakhstan Lebanon Malaysia Mexico Moldova, Republic of Russia Saudi Arabia Singapore South Africa South Korea Switzerland Taiwan (Chinese Taipei) Turkey Ukraine United Kingdom United States WHO

Target time assessment is Having a complete valid CRP application, the NRA promptly decides whether or not to apply the procedures, marks in its records that the product is being processed under the CRP, and informs WHO and the applicant, accordingly. In the case that the NRA decides to register the product in line with the procedure, WHO or the WLA shares assessment and inspection reports, typically within 30 working days of receipt of the request or expression of interest from the applicant to participate in the CRP. Once all reports are received, the 90-working-day period starts (that is, a regulatory period in which NRAs should decide on the registration in line with the procedure. The NRA should communicate its decision within 30 working days to the applicant and to WHO. They may decide to refuse to issue a registration. Reasons for refusal and the conditions for registration, including post-registration commitments, should be formally prepared and concurrently shared with the applicant and WHO within 90-working-day regulatory period. .