On Friday November 4, 2022, China’s National Medical Products Administration (NMPA) issued a significant announcement on future regulatory submissions. From December 1, less than a month from the announcement, the Center for Drug Evaluation of the NMPA will require all drug registrations to be submitted electronically to replace traditional paper submissions.
The NMPA has drafted five guidelines to support the switch to electronic submissions. These include:
- Implementation of electronic submission of drug registration application
- Notice on relevant requirements for electronic submission of drug registration application
- Technical requirements for electronic optical disk of application materials
- Electronic document structure of drug registration application
- Letter of commitment
Industry has until November 20 to submit comments.
China has been rapidly moving toward electronic submissions for the past five years, first submitting draft eCTD guidance in 2017, then in September 2021 the NMPA announced it would accept eCTD submissions for certain pharmaceutical and biological products. While, for now, the eCTD remains voluntary, the speed at which the health authority has moved with this and previous announcements suggests companies need to prepare sooner rather than later.
The health authority describes the latest announcement as an effort to streamline processes and enhance services to “lighten the burden for enterprises, optimize the business environment and improve the efficiency of drug review and approval”.
While not as complex as the eCTD, electronic submissions to the NMPA will have to meet certain requirements on document quality, PDF versioning, document size and other document setups.
For those companies that are already submitting in the eCTD, the only change is a positive one, since there is no longer a requirement to deliver a paper submission to the CDE in parallel after December 1.
However, many small companies in China still submit in paper and those businesses will have to quickly prepare to meet the electronic submission requirements. These companies need to understand exactly what an electronic submission is and how to prepare one. While the guidelines state they must prepare PDF documents and submit through an electronic disk, they need to understand the requirements for those documents. For example, can they simply scan the documents and create PDFs, or must they create more formal PDF documents to include bookmarks, hyperlinks and thumbnails?
Companies will need to go through the guidelines carefully to ensure they meet the requirements for preparing electronic submissions, and they will have to do this in just a matter of weeks.
For international companies, one further challenge is the fact that all the guidance documents are currently only available in Chinese. The English translation version is under preparation.
My colleagues and I are working through the guidelines to provide advice to clients and our team is able to manage electronic submissions on behalf of clients.
About the author:
Jie Zhang is Associate Director in Business Development at PharmaLex China.