Since the reform of drug review and approval in 2016, China's raw materials, pharmaceutical excipients and pharmaceutical packaging materials 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, registrants of raw materials, pharmaceutical excipients and pharmaceutical packaging materials can register and submit relevant information in the Drug Evaluation Center (CDE) platform of the State Drug Administration.

◆ After the registration number of API, pharmaceutical excipients and pharmaceutical packaging materials is obtained, the CDE platform will publicize the registration number, product name, enterprise name and production address and other basic information of the corresponding API, pharmaceutical excipients and pharmaceutical packaging materials.

1, API registrant

The relevant registration shall be carried out in the Drug Evaluation Center (CDE) platform of the State Drug Administration in accordance with the law.

* Domestic API manufacturers register their products as API registrants. Raw materials produced overseas may be registered with a Chinese agent.

2, registration objective:

Approach ① : domestic listed apis can apply for separate review, and the registration number will automatically change after the review “ A” .

Way 2: The API completed the platform registration after the formal review to get “ I” The status of the registration number, which passes the technical review when it is associated with the drug preparation review, the status of the registration number is “ I” Become “ A” .

1, registration type

Raw materials developed and produced in China or abroad.

2, registration data requirements

apis should meet the requirements in the Notice of the State Food and Drug Administration on the Release of Registration Classification and Declaration Data Requirements of Chemical Drugs (No. 44 of 2020).

• Provide an outline catalog of application materials for apis;

• Gap analysis of registration data, pre-examination combined with variety information, and modification suggestions to customers based on drug evaluation requirements;

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

• Tracking the official review of API registration, sending answers to questions and submitting supplementary reply materials;

• API registration data update, including major changes, moderate changes, minor changes and basic information changes;

• The annual report of registered apis is submitted.