Sunday, January 24, 2021
Home Regulatory Affairs Drug Approval Process in China

Drug Approval Process in China

The National Medical Products Administration (NMPA) ( Chinese name translation in English “State Drug Administration” or China Food and Drug Administration CFDA)  and the Ethical Committee must approve a clinical trial application prior to the sponsor initiating a clinical trial.

First EC approves the application and NMPA’s approval depends on it.  China Follows the centralized process for ethical review of the clinical trial application.

- Advertisement -

The ethical review process has three layers:  national EC, provincial ECs, and institutional level ECs.

China’s National Health Commission (NHC) is responsible for managing ECs nationwide by establishing the National Committee of Medical Ethics Experts which develop policies for ethical review.

Please see the below tables for a comprehensive view of the drug approval process.
The drugs are characterized into 5 Categorize as per New regulation by CFDA on Mar-2016.

Classification of Drugs and Definition

Clinical Trial Requirements

The drug approval process in other countries:

Drug Approval process-FDA
Drug Approval process-FDA
Big Change in FDA process for Biologics:
The Drug approval process in EU:
Drug Approval Process in India
Orphan Drug Designation in US, EU and Japan
Approval pathways of Fixed dose combination (FDC) in India


Please enter your comment!
Please enter your name here

18 + ten =

Most Popular

What is the process for Submission of Synopsis?

1.1 a. "Prior to submission of a thesis synopsis, a comprehensive assessment of the research work should be carried out by a...

COVAX Announces new agreement, plans for first deliveries

January 22, 2021: COVAX, the global initiative to ensure rapid and equitable access to COVID-19 vaccines for all countries, regardless of income...

FDA Approves OPDIVO® with CABOMETYX® as First-line Treatment for advanced Renal Cell Carcinoma

22 Jan 2021:  Bristol Myers Squibb announced that OPDIVO®(nivolumab) 240 mg (injection for intravenous use) every two weeks or 480 mg every four weeks...

FDA granted approval of Cabenuva and Vocabria to ViiV Healthcare for HIV

January 21, 2021: "The U.S. FDA approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human...