Suggestions on Filing Requirements for Sub-packing of Drugs Produced Overseas

 

On August 6, 2020, CDE (Center for Drug Evaluation), NMPA (National Medical Products Administration) issued a notice on the Procedures and Requirements for the Filing of Sub-packing of Drugs Produced Overseas. This article will remind the marketing authorization holder (hereinafter referred to as "MAH") of drugs produced overseas as follows:

 

1.Such drug needs to complete the final pharmaceutical production process overseas and has obtained the drug registration certificate, the MAHs shall record in detail all changes and approval processes of the drug produced overseas, instead of only providing the final status of the drug. 

 

2.MAHs of drugs produced overseas shall entrust a domestic company in China to handle the relevant filing work. Thus, MAHs shall prepare notarized authorization documents along with the Chinese version.

 

3.In the process of filing, MAHs of drugs produced overseas are required to submit the agreements between MAHs and sub-packing manufacturers. MAHs shall pay attention to the qualification of the sub-packing manufacturers, specific requirements of the drug packing, packing materials, storage method, warranty period and related intellectual property issues, such as trademark authorization when signing the sub-packing agreements.

 

4.MAHs shall also pay special attention to the demand of the filing that the original contracts shall not be continued if the sub-packing manufacturer is changed. A sub-packing termination agreement shall be signed to make it clear that the cooperative relationship between the MAH and packing manufacturer has been terminated.

 

At present, China's pharmaceutical industry is strengthening cooperation with MAHs overseas. Such regulations aim to ensure drug safety, efficacy and quality controllability. MAHs overseas may keep an eye on relevant policies and regulations of NMPA in order to speed up the international exchanges and cooperation of the health industry.