Major Regulatory Changes: Excipients and Packaging in China

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We are frequently asked about the Chinese CMC rules. Many companies, including the top global drug companies, stumble on this issue. It is an understatement to say this is a complicated matter. We will have related articles in the coming months. In this article, we focus on the new CMC developments.  

For that, we asked Ms. Lei Liu, VP of Regulatory of FMD, to help us understand the recent changes that will have a significant impact. Ms. Liu has over two decades of regulatory experience with Big Pharma, biotech, and CRO. Here is what we learned.

In August 2019, China’s drug regulators made changes to the review & approval of API, excipients, and packaging materials (AEPs); This will have a long-lasting impact for foreign pharmaceutical companies who plan to enter the China drug development market.

Under the new rules, the application for the drug and its API, excipients and packaging material will be linked and reviewed together. The drug applicant must provide an AEP Registration Number and the AEP Registrant Authorization Letter when applying for IND and NDA. The CDE, the office that reviews all applications within the NMPA, will reject applications that do not include these documents. If this happens, the clock on your application is reset. For instance, if the IND approval time by law is 60 working days, and your application is rejected, the 60-day deadline will restart from Day 1 of your revised application submission date. Since it could take 2-4 months to receive the AEP registration documents, this rejection can delay your IND approval by many months.

The good news is that the AEP registration is simple. First, you need to prepare the dossier per CDE requirements. The dossier is relatively straightforward. You can borrow much of the information from the IND/NDA. An experienced regulatory professional can help you do this. Second, submit dossiers through your local affiliate or a CRO. That’s it!

If your company has an affiliate in China, that affiliate can do the filing. Otherwise, a local CRO can do it for you. The key is that you need to be aware of this new requirement and plan ahead.

About the Author:

Lei Liu is the VP of Regulatory Affairs of FMD. She has been working in the regulatory affairs arena for over 10 years. Over the past decade, she led teams to successfully execute over 150 registration cases for biopharma companies. She has MRCT application in China simultaneously with a global trial, strategy consultation of China-Asian and China-US combined trial submission