Major Regulatory Changes: Excipients and Packaging in China

Stay Up-To-Date on New Industry Trends. FMDView is a periodic publication on drug development with keen interests in China. We publish short articles on regulatory, clinical management, drug safety and related subjects. The authors are mostly FMD colleagues who work on the front line of drug development. Sometimes we will have articles by leading investigators in China to discuss their perspectives on innovative drug research. We welcome questions and comments from our readers. If you have questions, send them to us.

Major Regulatory Changes: Excipients and Packaging in China

We frequently are asked Chinese CMC rules. Many companies, including the top global drug companies stumbled 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 developments.

For that we asked Ms. Lei Liu, VP of Regulatory of FMD, to help us understand the recent changes that will have major impact. Ms. Liu has 2 decades regulatory experiences with Big Pharma, biotech, and CRO. Here is what we learnt.

In August, China’s drug regulators implemented changes in the review & approval of API, excipients, and packaging materials (AEPs). For foreign pharmaceutical companies who plan to enter the China drug development market, this will have long lasting impact.

Under the new rules, 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 resets. For instance, the IND approval time by law is 60 working days. If your application is rejected, the 60-day deadline will restart from Day 1 when your revised application is submitted. 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 IND/NDA. An experienced regulatory professional can help you do this. Second, submit dossiers through your local affiliate or a CRO. That is 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 are aware of this new requirement, and plan ahead of time.

For more information please contact Aprille Walker at

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 includes MRCT application in China simultaneously with global trial, strategy consultation of China-Asian and China-US combined trial submission


About FMD:

FMD is a full service clinical CRO focusing on innovative drug development. With its 1,700 employees in 20 offices in China, US, Japan, India, and Armenia, FMD has helped global drug developers advance clinical development for 12 years.