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Summary of the PharmaFORUM Webcast International on the topic “China's Regulatory Landscape: Key Updates and Procedures”
In the latest episode of the PharmaFORUM Webcast International on 9 July 2024, key updates and procedures regarding China's regulatory landscape were presented by Jenny Zhang (CSL Vifor, China). Enclosed is a summary of essential points regarding clinical trial applications (CTA), pre-submission activities, and marketing authorization applications (MAA) to consider.
China's CTA procedures have become more streamlined and now resemble those in the EU and US, albeit with unique and evolving requirements. Understanding Chinese regulations and authorities is essential and maintaining effective communication with the Centre for Drug Evaluation (CDE) is crucial for navigating the approval process successfully.
Pre-submission activities include essential consultation meetings, such as Pre-IND, End of Phase II/Pre-Phase III, and Pre-MAA meetings. Adequate sample preparation for testing and conducting a gap analysis between different pharmacopoeias should be factored into registration testing. Additionally, being prepared for potential site inspections covering R&D, manufacturing, and clinical sites is crucial. Consideration should also be given to bundled reviews for APIs, excipients, and primary packaging materials (PPM).
Factors impacting MAA approval include the frequently prolonged practical timeline for clinical trial data inspection, which can exceed the specified timeline and cause delays. Strong communication before and during the inspection helps set expectations and address issues proactively, reducing the need for extensive post-inspection follow-ups and minimizing delays. Planning and conducting testing prior to MAA filing can streamline the approval process, as a second testing request after submission can significantly delay approval. Additionally, a deficiency letter necessitates an 80-working day preparation period. Upon receipt of the supplemental dossier, the CDE resumes the review process, extending the standard timeline by one-third and the priority review timeline by one-quarter, potentially causing further delays.
Author
Verena Planitz
Conference Manager Pharma&Healthcare
v.planitz@forum-institut.de
You can watch the entire webcast here upon subscription:
https://forum-institut.vidivent.de/event/pharmaforumwebcastinternational/willkommen
