China GMP and Registration of APIs - Q&As

Recommendation

17/18 September 2024

Drug Master File Procedures in the EU, the US and Japan - Live Online Training
With updates on the CEP 2.0!

In December 2021, the ECA offered the Live Online Training "China GMP and Registration of APIs". During the Q&A sessions, many interesting questions were posed to the speakers team.

With regard to China's Registration procedures for APIs, a set of the most important questions raised during the training and the respective answers provided by our speaker Ms Marieke van Dalen, Global Regulatory Specialist, Aspen, The Netherlands, are listed in the following. All answers reflect the opinion of the speaker based on her experiences. 

Question 1: Is a local agent always needed for DMF submissions in China?

Answer: You definitely need one as they are the ones who can have direct contact with the Health Authorities (you cannot do that yourselves). It is key to have an agent who will know all the ins and outs of the (constantly changing) Chinese requirements.

Question 2: How to handle post approval changes and the communication with the agency/authority?

Answer: There is a guidance on how to classify and file changes in China. It is set up like the European Variation system with conditions and documentation to be filed. Also changes should be filed through the agent.

Question 3: What is the content of an annual report?

Answer: The annual report may contain all annual reportable changes made.
Please note that it is thus different from what you file in the US annual update letters for Drug Master Files! Also note that it always needs to be submitted in the first quarter of the year, regardless of the first filing date of your DMF.

Question 4: Are EU GMP-certificates necessary/supportive for APIs, which need to be registered in China?

Answer: Yes, you are expected to provide proof of GMP, so the EU GMP certificate, notarized and on top of that legalized by the Chinese embassy, is supportive.

Question 5: Is it possible to register a drug product with an API not described in the Chinese Ph?

Answer: Yes, in that case specifications will be set based on the information that you provided, combined with the recommendation of the testing labs in China.

The information regarding China's GMP requirements were provided and can be checked in the news Q&As: China GMP and Registration of APIs.