Excipients used in a drug product for the Chinese market need to be registered in China. The specific setup of such a dossier and the translation in Chinese is a critical part of the success of such a registration. A solid collaboration of registration experts with a local Chinese partner are a perfect match for this task.

Black Diamond Regulatory Consulting, LLC (BDRC) has partnered with an expert consulting firm in China and can now offer various services to assist excipient manufacturers with their Chinese Registrations (Master Files). We can also act as an In-Country Agent for excipient companies who may not have their own facilities in China. The various types of services which can be provided are listed below. However, other services can be provided as well based on your need.

Chinese Excipient Registration (Master file)

Consulting & Chinese Excipient Registration Services

English Dossier Preparation assistance and Project Management by BDRC

• Excipient Registration Dossier Templates are available, if Client chooses to utilize them to develop their registration dossier

• Project management of dossier filing between Client, BDRC and In-country Agent

• Answering questions regarding registration filings

• Review of Client’s filing documentation and suggestions for improvement associated with the experience in the market

Dossier Preparation in China by Agent

• Monthly reporting of progress of registration document preparation and submission

• Additional meetings with Client to be scheduled on an as needed basis to discuss filings

• Review product for registration and determine if similar products are registered

• Prepare the submission package including completion of forms, Chinese translation, proofreading translation, print and copy documents (electronic as necessary)

• Submit documents to CDE including initial submission, follow-up on progress

Dossier Submission and Maintenance

• Local meetings with the CDE, as needed.

• Prepare and submit supplementary document packages (if required)

• Once completed, provide registration number and final copies of documents

• Advisement on Regulatory Changes

• Advisement on best practices associated with experience in filings.

• Submission of LOA

• Electronic submission to the portal

• Annual reports

Post-Dossier submission

• Amendments – Supplier Changes and CDE changes

Chinese Pharmacopeia (ChP 2020) Compliance Consulting Services

In addition to the services in connection with the Chinese Registrations BDRC also offers ChP 2020 compliance consulting services to help clients technically assess their excipients and verify that their excipients are compliant with the Chinese Pharmacopeia (ChP 2020). It will be vital for any excipient or pharmaceutical company having products in the Chinese market to ensure compliance with the current Chinese Pharmacopeia. The services which BDRC can supply include the following:

• Chinese to English or English to Chinese translation of ChP monographs, general chapters or other documents can be provided as needed.
• Technical comparisons of ChP 2020 monographs and general chapters to ChP 2015 monographs and general chapters
• Technical comparisons of ChP 2020 monographs and general chapters to monographs and general chapters in various other global pharmacopeias (USP-NF, Ph.Eur, JP, etc.)
• Evaluation of test method equivalence between monograph requirements in ChP 2020 and relative test methods in other global pharmacopeias
• Development of strategies for achieving test method equivalence between ChP 2020 and other global pharmacopeias
• Validation and verification of test methods and results related to ChP 2020 compliance using local labs in China
• Compilation of supportive reports to demonstrate ChP 2020 compliance that can be used in China Excipient Registration Dossiers