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 The SRA CRP pilot was initiated in 2015. It uses the regulatory expertise of SRAs to facilitate and accelerate the national regulatory assessments and approvals of any SRA-approved finished pharmaceutical products (including small molecules, innovator products, biologicals, generics, biosimilars, and vaccines) that are relevant to public health needs..
Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Bangladesh Bhutan Botswana Burkina Faso Burundi CARPHA-CRS Cameroon Congo, Democratic Republic of the Congo Cote D'Ivoire Ethiopia Gabon Gambia Georgia Ghana Kenya Lao People's Democratic Republic Malawi Mali Mauritania Mozambique Namibia Nepal Nigeria Rwanda Senegal Sierra Leone South Africa Sri Lanka Tanzania Uganda 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
Participating NMRAs will use the data submitted to support their decision-making regarding registration. They will seek to issue an "accelerated" decision on registration within 90 days of their acceptance of the submission. The procedure will not interfere with their national, regulatory decision-making processes, or with national legislation, or with levying of regulatory fees. Similarly, it will be the NMRAs’ responsibility to reach agreement with applicants regarding specific risk-management plans and pharmacovigilance follow-up.