Introduction of adjuvant registration

Introduction of laws and regulations

• Document No. 134 - Announcement of the General Administration on Matters Concerning the Related Review and Approval of Pharmaceutical Packaging Materials and Excipients and Drugs (2016 No. 134); separate approval of excipients had been clearly canceled 

• 2016 No. 155-Notice of the General Administration on the issuance of the requirements for the registration of materials and excipients for pharmaceutical packaging materials (for trial); requirements for the preparation of materials for adjuvant. 

• 2017 No. 146-Announcement on Adjusting the Review and Approval of APIs, Pharmaceutical Excipients and Pharmaceutical Packaging Materials (2017 No. 146); supplement No. 134 

• 2018-CDE's notice on publicly soliciting opinions on the "Registration Data Requirements for Pharmaceutical Excipients (draft for comments)" and "Registration Data Requirements for Pharmaceutical Packaging Materials (draft for comments)" 

• Circular 56 of 2019-Requirements for supplementary materials; instead of Circular 155. 2019.8.15 effective •In 2020, CFDA establishes a system for related review, review and approval of pharmaceutical packaging materials
  

• In 2020, CFDA establishes a system for related review, review and approval of pharmaceutical packaging materials

Registration process

• To register an account on the platform, both password and key are required; The key costs RMB 280.

      For details, please refer to Attachment 1, "Explanation on the use of the original auxiliary package CDE registration platform".

• Log in the system to fill in the application materials, download the “word” form and print it, sign and seal it at last.

• Materials that need to be submitted to CDE: CD-ROM and signed application form, other originals are not needed to submit. Labels are required for CDs and mailing portfolios. For the cover format, see Annex 2 "CD Case Cover", the cover needs to be stamped.

• CDE review usually has 1-2 corrections. After being qualified, the website will be publicized directly without issuing a certificate. Specific inquiry address: http://www.cde.org.cn/

• If subsequent excipients are applied to the product later, an associated review will be required during product registration.

Case introduction 1 (From NAR Consulting)

• Basic information: In 2019, an US company commissioned us to register its adjuvant (produced in the US) in China. The registered product is chemical synthesis adjuvant, and there are included in the pharmacopoeia excipients in China and abroad, the route of administration is oral. 

• Difficulties: the materials provided by the customer were very limited. Our company took advantage of technology to quickly compile the application materials and submit the dossiers on time. 

• Successfully registered in October 2019
  

Case introduction 2 (From NAR Consulting)

• Start time：beginning of 2020 

• Registered substance information: imported high-risk (injection) pharmaceutical excipients 

• Difficulties: the quality control standards for registered substances are formulated according to USP, which are different from ChP, and the revision is needed according to ChP.

• Successful registration in June 2020

If you have any questions about the DMF registration for APIs, adjuvants and pharmaceutical packaging materials, please feel free to contact us, thanks!