![]() According to the revised Chinese Drug Registration Regulations (DRR) effective from 1 July 2020, technical review will be conducted in parallel with site inspections, with a stipulated time limit of 130 working days. Notably, initiatives to optimize processes are already in place. Lastly, requirements of testing of drug samples collected during on-site inspections in China, and not in the USA, further extended the timeline.ĭespite remarkable improvements in drug review in China, several future priorities should be considered, including optimized review processes, detailed requirements and sufficient resourcing. The FDA instead implemented spot-check inspection of the contract manufacturer in the USA, given their record of good compliance with the required standards. Taking a risk-based standpoint, the NMPA conducted a full-scale inspection of the manufacturing facility in China because it is a brand-new plant. In the case of zanubrutinib, GCP inspection occurred after completion of the primary review, with GMP inspection after supplemental review (Supplementary Fig. Moreover, technical review and on-site inspection are conducted in parallel by the FDA, whereas inspections by the NMPA are generally triggered after review and verification of the specifications and processes of drug manufacturing. By contrast, one or two rounds of data supplements and review are generally required by the NMPA, as exemplified in the approval of zanubrutinib (Supplementary Fig. For example, the FDA has stringent NDA acceptance criteria to promote a single-cycle review. Nevertheless, discrepancies in the review cycles and sequence of procedures widened the time gap between the two approvals. ![]() Procedurally, both agencies conduct a pre-NDA meeting, NDA acceptance, filing review, technical review and on-site inspections for Good Clinical or Manufacturing Practice (GCP or GMP) before official approval. ![]() The two expedited approvals after priority reviews of comparable datasets underscore the scientific tenets of drug regulation and concordant regulatory requirements however, the 6-month lag in the NMPA approval suggests discrepant mechanisms of drug review and approval.
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