For pharmaceutical companies aiming to enter the Chinese market, understanding the Drug Master File (DMF) process for Active Pharmaceutical Ingredients (APIs), excipients, and packaging materials is essential. The China DMF provides crucial details about the quality, safety, and efficacy of these components, making it a key requirement for drug product registration in China.
What is China DMF and Why is it Important?
A Drug Master File (DMF) is a confidential document submitted to the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA). It contains comprehensive information on the manufacturing process, quality control, and stability of APIs, excipients, or packaging materials used in drug production.
There are two China DMF statuses: “I” and “A”:
- The letter “I” represents an inactive China DMF number
After submission to CDE, a format review and feedback is provided in around 5 workdays; the DMF number will be published on the CDE website with an inactive status, indicating that it is awaiting a drug-associated technical review. Once you receive the China DMF Inactive Number. You may export your product to China using an “I” DMF number.
- The letter “A” denotes an active China DMF number
Once the technical review associated with the finished drug is complete and the drug is approved, the DMF number will be activated and become “A” status.
The DMF serves as an official reference for regulatory authorities, enabling them to evaluate the quality, safety, and efficacy of pharmaceutical components. This evaluation is a critical step in drug registration, making the DMF a mandatory requirement for both API/excipient/packaging material registrations and finished dosage forms. Additionally, the NMPA reviews DMFs during routine inspections, making it crucial to maintain a complete, accurate, and up-to-date file.
Key Information Required for China DMF
The DMF must include detailed information about the manufacturing process of the API, excipient, or packaging material. This includes manufacturing controls, equipment, quality control testing methods, method validation, Certificates of Analysis (COAs), product specifications, and stability studies. For certain products, a compatibility study may also be required to ensure the packaging material does not interact negatively with the drug.
DMF Filing Process in China
Filing a DMF in China is a complex process that requires careful preparation and close coordination between the manufacturer and regulatory authorities. In addition to the technical documentation mentioned above, companies must submit several administrative documents, such as:
- Letter of Authorization
- Business License
- Good Manufacturing Practice (GMP) certificate
- Detailed Table of Contents
- Comprehensive summary of DMF contents
- Others (Contact for detailed checklist)
If you have US DMF or approval in other countries, this would accelerate the documentation process, as we will use the data as reference and a basis for adjusting the dossier to comply with local China DMF requirements.
Challenges and Best Practices for DMF Registration in China
One of the primary challenges foreign companies face when registering a DMF in China is the language barrier and compliance to local China requirements. All documentation must be submitted in Chinese, and the regulatory requirements can differ significantly from those in other countries.
To ensure a smooth DMF filing process, it’s important to work with an experienced regulatory affairs team familiar with China’s regulatory landscape. Here are some best practices:
- Plan Ahead: Begin the DMF preparation early to identify and address any potential data gaps.
- Accurate Documentation: Ensure all documentation is complete and adheres to the NMPA’s requirements.
- Timely Communication: Stay in close contact with the CDE to respond promptly to any questions or requests for additional information.
Conclusion: Why a Well-Prepared DMF is Essential for Success in China
A well-prepared DMF is crucial for any pharmaceutical company looking to enter the Chinese market. Not only does it streamline the registration process, but it also helps ensure compliance with China’s stringent regulatory standards.
At Accestra, we specialize in helping pharmaceutical companies successfully navigate the DMF filing process in China. With years of expertise, our team is well-equipped to assist with the preparation and submission of DMFs for APIs, excipients, and packaging materials, ensuring your DMF remains up-to-date and compliant.
Contact Us
If your company plans to distribute Active Pharmaceutical Ingredients (APIs), Excipients or Packaging materials for use in pharmaceutical finished products in China, then is it necessary to ensure you have China DMF ready for client so they can immediately market your product. We can help you obtain DMF “I” status in 2-5 months so you may share the DMF number to client for marketing approval.
Contact us at info@accestra.com or visit DMF China to learn more about how our expertise can help you navigate the DMF filing process in China.