What is CDE in China?
Per the DRR, NMPA’s Center for Drug Evaluation (CDE) is responsible for the evaluation of drug clinical trial applications, drug marketing authorization applications, supplementary applications, and overseas drug production registration applications.
Does China have an FDA equivalent?
The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA). The predecessor to the NMPA was initially founded in 1998 to oversee drugs and medical devices.
Does China follow GCP?
China’s current good clinical practice guideline was introduced in 2003, which was a drastically altered version of ICH E6 guideline. The Chinese GCP does not focus too much on safety.
What is China DMF?
Drug Master File (DMF) in China.
How are drugs approved in China?
National Medical Products Administration The drug category in which an applicant chooses to register determines the clinical trial application review and approval or filing process. Per the SC-IRP, the SAMR-Org, and CHN-21, China established the State Administration for Market Regulation (SAMR).
How do drugs get approved in China?
After completing the pre-clinical studies and clinical studies supporting the drug registration, the applicant should submit the drug marketing authorization application according to the requirements. After the formal examination of the application materials, acceptance will be given if they meet the requirements.
Why is GCP not in China?
Google abandoned plans to offer a major new cloud service in China and other politically sensitive countries due in part to concerns over geopolitical tensions and the pandemic, according to two employees familiar with the matter, revealing the challenges for U.S. tech giants to secure business in those markets.
How do I file a DMF in China?
To register for DMF filing you need to submit an application dossier to China’s Center for Drug Evaluation (CDE). They will review your application for documentation completeness and you will get an inactive filing number within 5-10 working days.
How long does it take for a drug to be approved in China?
A very substantial change is the approval time for a clinical trial application (CTA). In the past, it took two to three years for CTA approval. And now, by default, it is a 60 working day “silent approval,” meaning if no response is received in 60 working days the application is approved.
How long do clinical trials take in China?
As noted on CR Medicon, the usual duration for the China State Food and Drug Administration (SFDA) to approve clinical trial applications is 10 months. Regulatory reform that has taken place in China has improved the trial review and approval process.
Does Google store data in China?
While Amazon and Microsoft sell their cloud services in mainland China, Google hasn’t. But about three years ago, the company began talks with Chinese firms about providing its main data storage service in the nation through a joint venture, as Amazon and Microsoft do.