China Clinical Trial Application / Investigational New Drug Application Procedures

Jan. 13th, 2023

To help international pharma companies register drugs in China, this article introduces

  1. IND Applicant Qualification
  2. IND Application Scope
  3. IND Application Dossier
  4. IND Application Submission Procedures
  5. BaiPharm’s IND Application Service

1. IND Applicant Qualification

Domestic applicants should be companies or drug research institutions that are registered in China and capable of taking legal responsibilities independently.

Overseas applicants should be lawful pharmaceutical companies. They should appoint corporate entities in China to act as their local agents for submitting the application.

2. IND Application Scope

The following drugs are permitted for clinical trial application:

  • A new drug applying for clinical trial;
  • A drug, whose clinical trial has been approved, applying for adding a new indication;
  • A drug, which has obtained marketing authorization, applying for adding a new indication.

3. IND Application Dossier

Before submitting the IND application, the applicant should complete the CMC (chemistry, manufacturing, and controls) and toxicology researches to support the clinical trial. Phase I clinical trial should contain the following eight documents:

1) Table of contents for all the documents included in the application;

2) Introduction and the general plan for the research;

3) Investigator’s brochure;

4) Clinical trial protocol or plan;

5) CMC research information;

6) Non-clinical research information;

7) Statement about the drug’s previous clinical use;

8) Overseas research materials.

Besides, the applicant should provide the following information to CDE:

1) Situation of the pharmacovigilance system;

2) Name list of relevant parties in the clinical trial;

3) Document on the ethics committee review;

4) Document on the pre-submission communication with CDE.

4. IND Application Submission Procedures

See the procedures at BaiPharm.

5. BaiPharm’s IND Application Service

As a professional regulatory compliance service provider, BaiPharm helps pharma companies submit IND applications fully compliant with CDE’s regulatory requirements. Here are what we can offer:

  • Applying for pre-IND meeting and preparing materials for the meeting;
  • Conducting feasibility assessment/ data gap analysis for IND application to avoid possible deficiencies in application dossier and minimize the risk of rejection;
  • Preparing the outline of IND application dossier;
  • Writing, translating, reviewing, and submitting the IND application dossier in CTD format; e-CTD document editing and format conversion;
  • Providing support for testing sample and testing application, and tracking the review progress;
  • All-the-way consulting service for IND application until approval, including communicating with CDE reviewers, replying to deficiency letters from CDE, preparing and submitting supplemental applications, etc.

[Read more at BaiPharm]

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