WHO COLLABORATIVE PROCEDURE
Collaborative Procedure for Accelerated Registration is a voluntary procedure involving WHO-prequalified medicines or medicines approved by stringent regulatory authorities where by the applicant agrees to share with TFDA the assessments reports developed during WHO – prequalification.
This was implemented in 2012 after TFDA signed a Memorandum of Understanding (MoU) with WHO for WHO - PQ Collaborative Registration Procedures were signed in 2012.
The collaborative registration procedure serves to facilitate and accelerate national registration of pharmaceutical products which the WHO Prequalification of Medicines Team (WHO/PQT) has already assessed and prequalified. WHO/PQT assessment and inspection reports are shared with participating National Medicines Regulatory Authorities (NMRAs) at the manufacturer’s request. The decision about national registration of a product is then expected to be issued within 90 days of information sharing.
Procedure for submitting applications for WHO Collaborative accelerated registration
In order to submit a prequalified FPP for registration the applicant (usually the manufacturer) should sign and email a consent form (Appendix 2) to the following email address: email@example.com This will serve to grant WHO permission to share its evaluation information with the TFDA. The signed originals of the consent form should be posted or sent by courier to: World Health Organization, L25620 Avenue Appia1211 Geneva 27Switzerland.
Advantages of the procedure
- Shortening the approval time; i.e. the products approved within 90 days from the day of submission.
- Capacity building for assessors since through access to WHO PQ assessment reports.
- Opens up communications with manufacturer which provides real time communication and resolution of the issues on time.
- Builds confidence among regulators as they work together through work sharing on assessment reports on WHO- PQ Mednet website.
Products registered under the procedure
By January 2018, a total of 21 products have been registered through the procedure. The average time for registration was 78 days