China Pharmaceutical Excipient Registration

Registration of Pharmaceutical Excipients in China

Pharmaceutical excipients are excipients and additives used in the manufacture of pharmaceutical products and the preparation of prescriptions. They are a critical part of pharma formulations. In 2019, the NMPA implemented an updated process for the registration of pharmaceutical excipients in China replacing the pre-market approval policy for pharmaceutical excipients that had been in place for more than a decade. Under the revised regulations, manufacturers of pharmaceutical excipients must submit pharmaceutical excipient filing dossiers (i.e., DMFs-Drug Master Files) to the NMPA. Only after passing the administrative review and receiving pre-assigned DMF numbers can the pharmaceutical excipient manufacturers sell their product to Chinese manufacturers of formulated drugs and export to China.

Pharmaceutical excipients (excipients) manufacturers should directly file DMFs with the NMPA for the required technical information. Overseas manufacturers not operating in China should entrust their domestic subcontractors or agents to file their DMFs. Both manufacturers and their agents shall be responsible for the authenticity and integrity of the DMFs that are submitted.

About Us

Our company focuses on the unique regulatory requirements for pharmaceutical excipient registration to accelerate your drug's introduction to China.

Our company provides regulatory affairs, quality, and safety services to medical device and pharmaceutical companies worldwide. Our team of experts is familiar with current Chinese excipient registration regulations and has many years of experience in registering DMFs of pharmaceutical excipients in China for foreign manufacturers. We have the ability to provide comprehensive services to assist excipient manufacturers with the registration of their products in China. And our company is qualified to be a qualified and licensed in-country agent and undertake compliance obligations for excipient manufacturers without offices in China.

Application Documents

In order to complete the registration of pharmaceutical excipients in China, we help our clients prepare the following application documents that need to be submitted to the NMPA:

✓ Summary, including drug names, certifications, basis and objectives referring to the application and research, the sample packaging and labeling draft, etc.

✓ Pharmaceutical data, including experiment data and related literature on quality research, compatibility with drugs, stability research, etc.

✓ Pharmacology and toxicology study information, including studies and literature on general pharmacology, acute/single dose toxicity, chronic toxicity, etc.

✓ Clinical study information, including investigational plan and clinical study protocol, clinical study report, etc.

China Pharmaceutical Excipient Registration Services

Consulting and Chinese excipient registration services

• China DMF registration consulting service
• Excipient registration dossier template available
• Project management for dossier filing
• Review of the client's filing documentation

Dossier preparation

• Review product for registration
• Gap analysis of available data and development of DMF registration strategy and timelines
• Provide the list of documents required for China pharmaceutical excipient registration
• Prepare DMFs according to China NMPA requirements and prepare the submission package, including Chinese translation, proofreading translation, etc.
• Submit documents to CDE and follow up on the progress

Dossier submission and maintenance

• Assist with NMPA sample testing for high-risk products
• Support on-site NMPA inspections if needed
• Communicate with CDE reviewers on DMF submissions
• Respond to deficiency letters received during the review process
• Prepare and submit supplementary applications
• Advise on regulatory changes
• Submit LOA
• Prepare and submit annual reports
• Amendments–supplier changes and CDE changes

If you need help or have a question, please feel free to contact us for more details.