Since the reform of drug review and approval in 2016, China's raw materials, pharmaceutical excipients and pharmaceutical packaging materials (hereinafter referred to as original and auxiliary packages) have gradually entered the stage of associated review and approval.

According to the Drug Administration Law of the People's Republic of China, the Implementation Regulations of the Drug Administration Law of the People's Republic of China, the Measures for the Administration of Drug Registration, the Announcement of the State Administration of the People's Republic of China on the Adjustment of the Review and approval of raw materials, pharmaceutical excipients and pharmaceutical Packaging Materials (No. 146 of 2017) and the State Drug Administration on further improving the drug related review and approval and supervision Notice of Matters (No. 56 of 2019) and other laws and regulations, the original and auxiliary package registrant can register and submit the relevant information of the original and auxiliary package in the Drug Evaluation Center (CDE) platform of the State Drug Administration, and after the original and auxiliary package has obtained the registration number, the CDE platform will publicize the registration number, product name, enterprise name and production address and other basic information of the corresponding original and auxiliary package.

Registrants of pharmaceutical excipients and pharmaceutical packaging materials shall register relevant products in the Drug Evaluation Center (CDE) platform of the State Drug Administration in accordance with the law, and domestic pharmaceutical excipients and pharmaceutical packaging materials manufacturers shall register their own products as supplementary package registrants; Pharmaceutical excipients and pharmaceutical packaging materials produced overseas may be entrusted to Chinese agencies for registration.

1. Registration type:

Pharmaceutical excipients and packaging materials developed and produced at home or abroad.

2. Registration information requirements:

Pharmaceutical excipients should meet the requirements of Annex 1 in the Announcement of the State Food and Drug Administration on Matters Related to Further Improving Drug Related Review, Approval and Supervision (No. 56 of 2019).

Pharmaceutical packaging materials should meet the requirements of Annex 2 in the Announcement of the State Food and Drug Administration on Further Improving Matters Related to Drug Related Review, Approval and Supervision (No. 56 of 2019).

3. Registration process

Fill in the Application Registration Form for Raw materials, pharmaceutical excipients and pharmaceutical packaging materials → Submit registration information to CDE   →   Data through the form review, platform publicity “ " I” → → Through the technical review, the status of the registration number becomes “ A" .

• Provide the outline catalogue of pharmaceutical excipients and pharmaceutical packaging materials.

• Gap analysis of registration data, pre-examination combined with variety information, and modification suggestions to customers based on the requirements of preparation review.

• Review, translation, preparation and submission of registration materials.

• Tracking the official review of pharmaceutical excipients and pharmaceutical packaging materials registration, sending answers to questions and submitting supplementary reply materials.

• Update of registration data of pharmaceutical excipients and pharmaceutical packaging materials, including major changes, medium changes, minor changes and basic information changes.

• The annual report of registered pharmaceutical excipients and pharmaceutical packaging materials is submitted.