API Registration in China

I. Introduction

1. Regulatory Background

Drug Administration Law of the People's Republic of China

Regulations for Implementation of the Drug Administration Law

Provision for Drug Registration

Announcement on Issues Concerning the Further Improvement of Drug Associated Review & Approval and Supervision ([2019] No.56)


2. Scope

APIs will be sold to China or used in drug product that plans to register in China.


3. Requirements for Registration Dossier

The registration dossier must comply with the compilation requirements on API registration dossier stated in ICH M4 and relevant technical regulations issued by NMPA.


4.  Types of Registration

New Application, Variation and Annual Report.


5. Authority

Center for Drug Evaluation of NMPA (CDE)


II Registration Target

Beijing Canny Consulting Inc. offers professional consulting services for API registration in China. When the API dossier is being reviewed independently or associated with its drug product, Canny will assist and guide clients to pass the technical review so as to obtain status “A” (Active) on CDE platform.


III Content of Services

1. Act as local agent for API registration.

2. Provide an outline for the application dossier.

3. Perform gap analysis, evaluate risks, identify and correct deficiencies of the Applicant’s original documentation based on the current NMPA regulations.

4. Translation, compilation and submission of the application dossier.

5. Responsible for sample testing application, tracking and replying to questions raised by the authorities.

6. Track registration progress, reply to questions raised by authority and submit supplementary materials.

7. Submit variation dossier, including major changes, moderate changes, minor changes and basic information changes.

8. Transfer of registration of API.

9. Submit annual report to keep the registered API active.


IV. API Registration Procedure

Fill in the Application form → Submit application dossier to CDE → Once application dossier is accepted, CDE will publish the → registration number with status “I” on CDE platform → The application dossier is being technically reviewed → Once the technical review is passed, the status turns from “I” to “A”.