Information for manufacturers who experience delays in national registrations of prequalified medicines
National regulatory authorities (NRAs) of ten African countries have confirmed their participation in a collaborative procedure with WHO Prequalification of Medicines Programme (WHO/PQP). The procedure can substantially accelerate national registrations of prequalified medicines and can be used both in new applications for national registration and in pending registration processes.
National assessment could be concluded within 90 days if the manufacturer authorizes WHO/PQP to share its assessment and inspection information confidentially with the regulatory authority. Because pending applications can be at different stages of national assessment, the decision whether or not to apply the procedure is up to each respective NRA.
The product must have been prequalified based on WHO/PQP's own assessment. If necessary, applicants should update the dossier submitted for national registration in order to keep technical differences from the prequalified dossier to a minimum.
More details, the documentation package and WHO contact addresses are found at: