The National Health Regulatory Authority (NHRA) released Circular No. (26) 2023, on the revision of Resolution 32 regarding the fast-track registration procedures for pharmaceutical products.
In the statement released, NHRA mentioned 2 fast-track procedures prepared for product registration involving a 10-day registration procedure and a 20-day registration procedure.
10-Day Registration Procedure
This registration procedure is subjected to pharmaceutical products that are to be registered/approved by one of the reference authorities below:
Gulf Cooperation Council Central (GCC Central)
Saudi Food and Drug Authority (SFDA)
US Food and Drug Authority (US FDA)
European Medicines Agency (EMA)
SwissMedic
Medicines and Healthcare Products Regulatory Agency (MHRA)
The Batch-Releasing site should be registered with NHRA together with the above-mentioned authorities
Full e-CTD dossier of the product registration, same as registered in the above-mentioned authorities, together with a complete assessment report.
Declaration letter from the marketing authorization holders (MAH) to clarify all information is correct and as approved by the above-mentioned authorities.
20-Day Registration Procedure
This procedure is subjected to the pharmaceutical products that are not registered with any of the above-mentioned reference authorities.
MAH should note after completing the full e-CTD dossier submission for intended product registration, a Signed Checklist will be given by the New Registration team.
The intended registered products are not required to be registered in one of the reference authorities, but the Batch Releasing site is required to be registered in one of the reference authorities.
License will be issued for 1 year and registration requirements are expected to be completed within the period. If the requirements are not completed, the conditional registration will be inoperative and products will not be registered without any notification. While 4 additional years will be given if MAH manages to complete the registration requirements within the 1-year period.
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