WHO Collaborative Procedure
WHO – Collaborative Procedure for Accelerated Registration (WHO – CRP)
What is the WHO Collaborative Procedure for Accelerated Registration (WHO – CRP)
- Is a voluntary procedure where by an applicant agrees to share with TMDA the assessment reports developed during WHO – prequalification
- The procedure is governed by a Memorandum of Understanding (MoU) between TMDA & WHO
How to apply for the WHO - CRP
- Submit an application dossier for WHO prequalification
- Complete the prequalification process
- Submit a signed consent form (Appendix 2) to prequalreg@who.int
Advantages of using the WHO – CRP
- 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
- Utilizing the available resources and avoiding duplication of the assessment work
- For the list products which have been granted marketing authorization through this procedure click here
- For the List of WHO pre-qualified medicine Link
