Pharmaceutical Excipient 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

Excipients used in drug product that plans to register in the People’s Republic of China.

3. Requirements on Application Dossier

The application dossier must comply with the Attachment 1 of Announcement on Adjusting the Review & Approval Items of APIs, Pharmaceutical Excipients and Packaging Materials issued by NMPA.

4.  Type of Application

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 excipient registration in China. When excipient application dossier is being reviewed 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 excipient registration.

2. Provide an outline for application dossier.

3. Perform gap analysis, evaluate risks, identify and correct deficiencies of the original documentations provided by the Applicant based on the current NMPA regulations.

4. Translation, compilation and submission of application dossier.

5. Track registration progress, reply to questions raised by authority and submit supplementary documents.

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

7. Transfer of registration of excipient.

8. Submit annual report to keep registered excipient active.

IV.  Excipient 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 reviewed technically together with its drug product → Once the technical review is passed, the status turns from “I” to “A”.