About the planning of major drug discovery science and technology major projects new medicine clinical evaluation technology platform project management

The 2015-12-30 national health and population and family planning commission of the People's Republic of China

The WeiKe medicine special tube to do [2015] no. 120

Each subject responsibility unit:

In order to further strengthen the "major drug discovery" science and technology major projects (hereinafter referred to as the new special) new medicine clinical evaluation research technology platform (GCP) subject norm management, according to the interim provisions on national major projects of science and technology management (g&k hair [2008] no. 453), combining the drug clinical trial institution is carrying out "self audits" on a clinical trial data, please GCP construction project of this unit to assume responsibility unit and organization and management of project implementation progress seriously check list, notice the following:

, the GCP subject responsibility unit should earnestly fulfill legal person responsibility, further strengthening the construction of technical system integrity, advanced and standardization, improve the level of data management of standardization degree and the team structure, improve the operation management and supervision mechanism.

2, please each GCP subject responsibility unit seriously comb project implementation, the task completion, the organization to manage the situation, the main variety of evaluation and the implementation effect such as checking, and fill in the inspection report (see attachment).

Three, I will according to the situation of each unit inspection organization expert spot check, the existing management chaos, slow task to complete, fraud and other violations of the subject responsibility and responsibility unit, will be in accordance with the relevant regulations for processing, and recorded in the credit archives.

Four, GCP subject responsibility units as required, please fill in information, and shall be responsible for the authenticity and comprehensiveness. The inspection report, please use A4 paper to print and build official seal, print 2 copies of the material and the electronic file (sent to the email) on January 14 2016, submit it to me.

Materials submitted to the address: haidian district of Beijing zhongguancun south street no. 1 friendship hotel yingbin building room 503, organs of state health and family planning commission, new special management office, zip code: 100873.

Contact: xiao-ming shi

Contact phone: 010-68791550

Email address: xinyaobiangeng@163.com

Attachment: major drug discovery science and technology major projects new medicine clinical evaluation technology platform inspection report. Rar

"Major drug discovery" science and technology major projects to implement management office

On December 30, 2015