NMPA Research Base for Drug and Medical Device Regulatory Science Hainan Institute of Real World Data
/ EN
Trends

The Ethics Committee of Lecheng Pilot Zone Holds Its First Ethical Review Meeting

2022-03-20 519

On the afternoon of March 19, the Ethics Committee of Lecheng Pilot Zone held its first ethical review meeting.

The ethical review meeting was held online, attended by 17 members of the committee, and chaired by Wu Yilong, the director of the Ethics Committee of Lecheng Pilot Zone, a lifetime professor with the Guangdong Provincial People’s Hospital and president of Guangdong Medical Doctor Association. A total of seven projects were reviewed, including four on the usage of licensed imported medical products and three on real-world study.

The Ethics Committee was established initiated by the Lecheng Administration and guided by the Health Commission of Hainan and HMPA, which aims to promote the ethical review ability and multi-center clinical research review efficiency of Lecheng Pilot Zone and accelerate the application of licensed imported medical products and the launch of real-world studies. In order to ensure the quality, fairness and equity of the review, the Ethics Committee is composed of experts and representatives with rich working experience in related areas such as clinic, ethics, statistics and legal affairs from medical institutions inside and outside Hainan Province and in the Lecheng Pilot Zone.

The Ethics Committee mainly provides services such as ethical review on the usage of licensed medical products and real-world studies. Pharmaceutical enterprises, medical institutions and researchers can choose the Ethics Committee of Lecheng Pilot Zone or corresponding medical institutions according to their demands. The projects that have passed the review of the Ethics Committee of Lecheng can be exempted from another review of the Ethics Committee of medical institutions according to the principle of mutual recognition.
 

image.png

The ethical review meeting signified the official launch of the Ethics Committee of Lecheng Pilot Zone. In the future, it will further explore the ethical review standards and processes for real-world study and perfect the ethical review system of real-world study to provide referential experience for the ethical review of real-world studies in China.