eCTD Supporting Documents in China Available for Public Comments
China NMPA has issued drafts before the final release of the supporting documents for the “Measures for the administration of drug registration”, for public consultation:
- “Chemical drug registration classification and requirements for submission materials”,
- “Variations and requirements for submission materials of marketed chemical drugs”,
- “Technical guidelines for CMC variations research of marketed chemical drugs”,
- “Guidelines for the acceptance and review of chemical drug registration”,
- “Guidelines for acceptance and review of CMC variations of chemical changes”.
Above listed five drafts are now open for public comment through May 30, 2020.
Along with the above items, several other documents have also been released for public comment, including “M4 Module 1: Administration documents and drug information”, which is an updated draft based on the previous version from April 17th, 2019. These further revises both the structure and the materials required for the Chinese Module 1.
The implementation of this CTD format and the revised M1 are important in paving the way for eCTD implementation. The draft eCTD specification was first published on September 17, 2019. After the official issuance of these documents, it is expected that the related changes will also soon be reflected in the Chinese eCTD specification.
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