To conduct a clinical trial in China, applicants must obtain approval from both an Ethics Committee (EC) and the National Medical Products Administration (NMPA). The Center for Drug Evaluation (CDE) under the NMPA is responsible for reviewing applications related to drug clinical trials, marketing authorisations, supplementary filings, and overseas manufacturing products registrations. Before initiating a trial, the application must be reviewed and approved by the local EC, though NMPA review can be submitted in parallel.
All clinical trial and registration applications in China must be submitted in simplified Chinese and in electronic Common Technical Document (eCTD) format via the Drug Application System, which officially replaced paper submissions on January 1, 2023.
For foreign companies seeking to register their products in China, appointing a local representative as the Marketing Authorisation Holder (MAH) is mandatory. The MAH serves as the main liaison between the company and Chinese regulatory authorities. To formalize this arrangement, companies must provide a notarized and legalized authorization letter designating the local representative, who is responsible for all regulatory communications, submissions, and follow-up activities with the NMPA.
CTA Review Process in China
Before submitting a clinical trial application (CTA) to NMPA for review, it is highly recommended to meet with the CDE to confirm the application details and the feasibility of the trial in China. After submission, the CDE conducts a 5-working-day review to verify the format and a 60-working-day review for new drugs and Class II Medical Devices or a 90-working-day review for Class III Medical Devices. If the CDE finds any issues, it will issue an online query. Applicants must respond within 5 working days. If no issues are found, applicants should receive CTA approval and a CTA certificate.
NMPA Review Fees for CTA
The cost structure differs significantly between domestically manufactured and overseas-produced drugs. The registration fees for Overseas-Produced Drugs/Devices are as below as of Nov 2025:
| Application Type | Review Fees (RMB) |
| New Drug | 376,000 |
| Generic Drug | 502,000 |
| Supplementary Application (requires technical review) | 283,600 |
| Supplementary Application (no technical review is required) | 9,600 |
| Class II Medical Devices (First registration) | 210,900 |
| Class II Medical Devices (Change registration) | 42,000 |
| Class III Medical Devices (First registration) | 308,800 |
| Class III Medical Devices (Change registration) | 50,400 |
Required Documents for Clinical Trial Protocol Applications
The Common Technical Document (CTD) format is the standardised structure required by NMPA for regulatory submissions in China’s pharmaceutical and biotechnology sectors. The CTD dossier in China aligns with the ICH guidelines and is organized into the following modules:
Module 1: Administrative Information and Prescribing Information
This module is region-specific and contains national and administrative information required by the NMPA.
- Application forms
- Investigator’s brochure
- Informed consent
- Clinical study protocol
- Proposed product information (labelling, package leaflet)
- Manufacturing Process Information Sheet (MPIS)
- Manufacturing and Testing Procedure (MTP)
- Regional certificates (GMP, GLP, MAH authorization)
Module 2: Overviews and Summaries
This section provides a high-level summary of the information contained in Modules 3, 4, and 5. It includes the Quality Overall Summary (QOS), Non-clinical Overview/Summaries, and Clinical Overview/Summaries.
Module 3: Quality
This section covers the quality of the medical product and details on its manufacturing process. It contains the detailed chemical, pharmaceutical, and biological data, also known as Chemistry, Manufacturing, and Controls (CMC) information.
Module 4: Non-clinical Study Reports
This module details the non-clinical (animal) study reports, including pharmacology, pharmacokinetics (absorption, distribution, metabolism, excretion), toxicology, and drug interaction data.
Module 5: Clinical Study Reports
This module contains the detailed clinical information and study reports related to biopharmaceutics, clinical pharmacology, efficacy, safety, and a benefit-risk conclusion. Clinical trial data may be exempted under specific conditions, but generally, comprehensive reports are required.
Reference:
https://www.nmpa.gov.cn/zwfw/zwfwjfxx/jfxzxksfgs/index.html
Author: Wai Theng Lee, Clinical Research Partnerships Manager
