Drug Master File Series - API Registration in China
Global Regulatory Partners, Inc.
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Overview:
Since 2017, the Chinese health authority NMPA had put in place a new process for the registration of DMFs for Active Ingredients (API) in China. In order to register their APIs with NMPA, manufacturers have to submit the DMF application on-line using the “DMF Registry Platform”, compile the complete DMF registration dossier in CTD format and send burned CD to NMPA CDE office.?
Foreign API manufacturers, without local presence in China, should appoint a local representative in China that can register their DMF with NMPA on their behalf.
?DMF Registration Process & Local Testing
After receiving the DMF registration dossier of the API, NMPA performs an administrative review of its content, assigns a DMF number before disclosing the status of the DMF on its website as Inactive (marked as “I”). Then, NMPA requests the DMF applicant to pay the DMF registration fee and conduct a local analytical testing of the API in China laboratory. The payment of the registration fee should be made within 20 days of the invoice date; however, the local testing should be completed before the approval of the drug product that includes such API in its formulation.??
Local testing should be conducted through NIFDC (National Institute for Food and Drug Control), and the process takes about 3 to 4 months.??
About the Author:?
Michael Zhang is a seasonal regulatory expert with over 12 years global regulatory submissions, 10 years APAC regulatory intelligence, strategy and submission management for innovative drugs and biologics. He also has extensive experience in Regulatory/Clinical/Safety content management and translation excellence model design and implementation in Pfizer R&D.??