Clinical Trials in China
As is the case in many countries around the world, a local clinical trial is almost always required for the registration of drugs and medical devices in China. Since drug registration in China follows global International Conference on Harmonization (ICH) guidelines, data requirements in China are like those in the United States and other developed countries.
Table of Contents
| Document Number | Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|---|
| Decree NO. 6 | Medical Device Clinical Trial Design Guideline | NMPA | This guideline applies to the medical devices with established product composition, design and performance, including therapeutic products and diagnostic products, while excluding in vitro diagnostic reagents clinical trial design in China. | English | For Sale |
| Document Number | Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|---|
| - | Guideline for Comparing the Same Variety of In-Vitro Diagnostic Reagents Exempted from Clinical Trials (Draft) | NMPA | The purpose of the guideline is to provide technical guidance for the applicants to compare in vitro diagnostic reagents that are exempted from clinical trials with the same variety of products, and to provide a basis for the technical review of this part of the data by the drug regulatory authorities. | English | For Sale |
| - | Guideline for Clinical Trials of In Vitro Diagnostic Reagents (Draft) | NMPA | This Guidelines is applicable to clinical trials conducted in China with in vitro diagnostic reagents administered as medical devices and applied for registration in China. | English | For Sale |
| Document Number | Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|---|
| - | Guidance for Clinical Evaluation of Proton/Carbon Ion Therapy System | NMPA | This guidance is to inform the applicants on the Clinical Evaluation of Proton and Carbon Ion Therapy System. | English | For Sale |
| Document Number | Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|---|
| - | Guideline for Clinical Trial of Orthokeratology Rigid Gas Permeable (RGP) Contact Lenses | NMPA | This document applies only to clinical trials for Rigid Gas Permeable Contact Lens products that use a re-shaping method to alter the corneal topography to achieve a temporary correction of refractive error. | English | For Sale |
GRP WHITEPAPER: Overview of Clinical Trial Application in China
In China, a Clinical Trial Application (CTA) should be submitted to the National Medical Products Administration (NMPA), to request the authorization to administer an Investigational Drug to humans. CTA can be submitted to NMPA for Phase I through Phase IV clinical trials, including bioequivalence trials, that are conducted in China.
GRP WHITEPAPER: REAL WORLD EVIDENCE FOR CLINICAL TRIALS IN CHINA
On January 7th, 2020, NMPA published a new guideline on "Real-World Evidence that defines Real-World Data (RWD) and Real-World Evidence (RWE) terms and clarifies their use during drugs' research and development and registration in China.