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 TMDA the assessments reports developed during WHO – prequalification.
This was implemented in 2012 after signing a Memorandum of Understanding (MoU) with WHO for WHO - PQ Collaborative Registration Procedure.
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 assessment report with the TMDA. 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 are approved within 90 days from the day of submission.
- Capacity building for assessors through access to WHO PQ assessment reports.
- Builds confidence among regulators through work sharing
Products Registered under the Procedure
For the list products which have been registered through this procedure Click here
For the List of WHO pre-qualified medicine Link: https://extranet.who.int/prequal/content/prequalified-lists