To all institutions concerned,

In accordance with the overall deployment of joint prevention and control mechanism plus science and technology development of the State Council in response to the outbreak of COVID-19, the guideline on applying for emergency project of prevention and control of the outbreak of COVID-19 is hereby issued in compliance with the relevant requirements of organization and management of key special projects of the National Key Research and Development Program “Prevention and Control of Public Safety Risk and Technical Equipment for Emergency”. Please conduct the project application according to the guideline. The Ministry of Science and Technology will, in accordance with the special requirements for prevention and control of the COVID-19 epidemic, select the optimal projects, provide substantial supports, and promote the implementation of the projects together with the National Medical Products Administration (NMPA). All projects will be subject to a comprehensive assessment of the Center for Medical Device Evaluation under NMPA. The National Institutes for Food and Drug Control (NIFDC) will establish the relevant standards and conduct performance evaluation.

The relevant matters are hereby notified as follows:

I. Requirements for project

1. The project should focus on the emergency requirement of point-of-care testing of 2019-nCov, highlight the result-oriented approach, center on the core objective of “rapid diagnosis of suspected patients and field screening of close contacts”, specify the research objective and timeline, and concentrate on tackling of problems.

2. Projects involving human research should be reviewed by the ethics committee as required, and written informed consent should be provided. Projects involving collection, preservation, utilization and external provision of human genetic resources should be implemented according to the relevant provisions of the Regulations on Management of Human Genetic Resources. Projects involving laboratory animals and animal experiments should comply with the national laws and regulations, technical standards and relevant provisions of laboratory animals, use qualified laboratory animals and conduct animal experiments in qualified facilities. The experiment process should be legal, and the experimental results should be authentic and effective. Meanwhile, the projects should pass animal welfare and ethical review.

3. The scientific data generated by the project should be unconditionally submitted to the platform designated by the Ministry of Science and Technology on schedule and be available to each institution undertaking the project and even to all scientists and the public in the future.

4. The leading organization of the project which has been approved should apply for the medical device registration certificate within half a month of the approval and meet the acceptance requirements.

II. Requirements for application

1. The applicant should file the application in the form of a project according to the research contents at the directions supported by the guideline. The project should cover all appraisal indicators at the corresponding directions in the guideline. Different topics can be set under the project. The project should be applied as a whole, and cover all appraisal indicators at the corresponding directions in the guideline. The applicant should recommend...

Appendix: Guideline of Applying Emergency Project of Product Development of Point-of-care Testing of 2019-nCOV

Ministry of Science and Technology

February 8, 2020