With respect to the above matter, we take note of the feedback from Pfizer on the negative experience with the pilot procedure on collaborative registration of products approved by stringent regulatory authorities (SRA). The objective of the pilot procedure, which is a voluntary process for all parties, was to assess the feasibility of collaboration in exchange of information (assessment and inspection reports) between a stringent regulatory authority “SRA” and respective national medicines regulatory authorities (NMRAs) in accelerating national registrations. Therefore, the feedback received from Pfizer is essential in assessing the utility of the procedure and address observed challenges.
Medroxyprogesterone acetate (MPA) was the third active drug substance to be included in the SRA pilot procedure. To date, we have 5 drug substances (9 products in total) through this procedure. For clarity, below are the basic principles of the procedure, since it appears there is some misunderstanding.
1. A valid submission should be submitted to the NMRAs using the usual channels of communication and complying with local requirements. Since the procedure is to assist in the technical review, it was agreed …show more content…
Similarly, Pfizer was to submit responses to each NMRA using normal procedures. Further action on any pending issues after the second review were to be addressed as usual by the individual NMRAs. Essentially, WHO’s role in the process was only limited to coordinating with the MHRA, Pfizer and NMRAs to initiate the procedure, and facilitate the two rounds of reviews. Thereafter, each NMRA had to finalise any outstanding issues and make a regulatory decision and inform Pfizer as per normal registration procedures. Afterwards, WHO’s role was to monitor the outcomes based on feedback from Pfizer (or NMRAs) and intervene when
Medroxyprogesterone acetate (MPA) was the third active drug substance to be included in the SRA pilot procedure. To date, we have 5 drug substances (9 products in total) through this procedure. For clarity, below are the basic principles of the procedure, since it appears there is some misunderstanding.
1. A valid submission should be submitted to the NMRAs using the usual channels of communication and complying with local requirements. Since the procedure is to assist in the technical review, it was agreed …show more content…
Similarly, Pfizer was to submit responses to each NMRA using normal procedures. Further action on any pending issues after the second review were to be addressed as usual by the individual NMRAs. Essentially, WHO’s role in the process was only limited to coordinating with the MHRA, Pfizer and NMRAs to initiate the procedure, and facilitate the two rounds of reviews. Thereafter, each NMRA had to finalise any outstanding issues and make a regulatory decision and inform Pfizer as per normal registration procedures. Afterwards, WHO’s role was to monitor the outcomes based on feedback from Pfizer (or NMRAs) and intervene when