Drug Review Center Website Added Publicity Column Clinical Trial Implied Licensing Era-Zhejiang Jianfeng Pharmaceutical Co., Ltd.

Drug Review Center Website Added Publicity Column Clinical Trial Implied Licensing Era

Release time:

2018-11-08

On November 5, the "Clinical Trial Implied License Publicity" column was added to the hot column of the homepage of the Drug Evaluation Center (CDE) website. This means that the clinical trials of new drugs in China have changed from express permission to implied permission in the past.

Entering the column, you can see that 8 acceptance numbers have been acquiesced, which are applications from pharmaceutical companies such as Merck Research and Development (China) Co., Ltd. and Platinum Pharmaceutical (Guangzhou) Co., Ltd.

Speeding up the reform of clinical trial management and adjusting and optimizing the review and approval procedures for drug clinical trials are one of the key tasks in the reform of the drug review and approval system. In July this year, the State Drug Administration issued the Announcement on Adjusting the Procedures for the Review and Approval of Drug Clinical Trials, which has made adjustments to the review and approval of drug clinical trials: for those who apply for drug clinical trials in my country, from the date of application acceptance and payment If the applicant has not received CDE negative or questioning opinions within 60 days, the drug clinical trial can be carried out in accordance with the submitted plan.

The first batch of 8 clinical trial registrations were announced by implied license, which means that China's clinical trial management reform has made new progress. The industry expects that more clinical trials will be launched as soon as possible under the new policy spring breeze, so that more good drugs and new drugs can benefit patients.

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