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