Author

Marco Theobold

Director of Medical Device and Drug Services

How To Submit Your Master Files to Chinese Regulatory Agencies

Oct 17, 2023

For China’s CDE and NMPA, Drug Master Files (DMFs) are secure collections of proprietary product data sent to regulatory bodies around the world. They provide proprietary information about the manufacturing, processing, packaging, and storing of human drugs. DMFs allow product manufacturers to share information with regulatory authorities without disclosing trade secrets to the drug companies that use their products.  

What is required in a DMF?

A DMF may contain information including, but not limited to:  

  • Facilities, processes, and articles 
  • Chemistry, Manufacturing, and Controls (CMC) 
  • Drug substances and drug substance intermediates 
  • Drug products 
  • Packaging material 
  • Excipient, colorant, flavor, essence, or material used in their preparation 

Each year, thousands of companies file DMFs to make it easier for drug manufacturers to use their products while protecting their intellectual property from. Different regulatory agencies require different data and formats for DMF submissions. This makes submitting and maintaining DMFs around the world extremely complicated and time consuming.  

As a result, there are few organizations with teams of DMF Specialists that work with companies to properly file and maintain their DMFs globally. One such company, Registrar Corp, has noticed a significant increase in requests to submit DMFs to China.   

China’s CDE & NMPA Master File Requirements  

In China, the Center for Drug Evaluation, National Medical Products Administration (CDE, NMPA) allows for the submission of three types of DMFs:Active Pharmaceutical Ingredients (APIs) Pharmaceutical Packaging Material and Pharmaceutical Excipient Master Files 

CDE, NMPA has many unique requirements for Master Files submission. These include: 

  • Proprietary portal: Applicants must submit basic information about their Master File(s) to obtain an MF number and registration form. 
  • Unique format and requirements: Applicants must follow the most current guidance or CDE’s announcement for submissions for different types of Master File. 
  • Mail submission: MF dossiers must be mailed to CDE, NMPA in a physical copy and the tracking information must be reported on CDE’s applicant portal. 
  • Administrative review: MF dossiers are checked to ensure they comply with current guidance or recent CDE announcements. After passing administrative review, Master File basic information is then published on CDE’s website. 
  • Chinese translation: All documents submitted to CDE, NMPA must be in Simplified Chinese. 
  • No email communications: Any communication with CDE, NMPA is to be conducted via phone during their specified business hours and in Chinese 
  • Designated enterprise: Overseas applicants are required to designate an enterprise that has legal persons within China to handle relevant registration matters (Decree of the State Administration for Market Regulation 27) 

Submit Your Master File Submission to China with Registrar Corp 

Registrar Corp offers direct support for MF submissions through our office in mainland China, which serves as the designated enterprise for our clients and handles all communication with CDE, NMPA.  

Many companies start with a DMF that was previously submitted to a different regulatory agency and need assistance adjusting the DMF to comply with CDE, NMPA requirements. Others start from scratch and need assistance from start to finish. Whether you need to make an adjustment or want full support, Registrar Corp makes CDE, NMPA Master File submissions quick and easy.  

Learn more about our international Master File services today. 

   

 

 

 

Author


Marco Theobold

Director of Medical Device and Drug Services

A highly regarded expert in medical device and drug regulations by the U.S. Food & Drug Administration (FDA), Marco brings a unique perspective for medical device and drug companies seeking to distribute products in the United States. He proudly provides guidance on FDA regulations for pharmaceutical, medical device, and radiation emitting device (RED) companies.

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