The main contents of the suggestions.
- Renovate clinical trial management system.
- Speed up the evaluation and approval process for the vital medicine and medical devices.
- Encourage medicine innovation and generic drug development.
- Strengthen the full life circle management of the medicine and medical devices.
- Improve the technical supporting capacity
- Strengthen the organization and implementation
- Use filing management for the clinical trial institution qualification.
- Support medical institutions, medical study institutions, medical colleges and etc. to conduct clinical trials.
- Improve the ethics committee rules.
- Increase the efficiency of the ethics evaluation.
- Improve clinical trial approval process
- Accept the oversea clinical trial data
- Support trailblazing clinical trials for the vital diseases.
- Investigate data fraud
- Speed up the evaluation and approval process for the vital medicine and medical devices
- Support the research and development for the Orphan Diseases medicine and medical devices.
- Implementation of the marketing authorized holder system.
- The implementation of the marketing authorized holder legal responsibility
- Establish marketing authorized holder report the adverse reaction and events system.
- Improve the medical device reevaluation regulations.
- Improve technical evaluation regulations renovation.
- Confidentiality duty of the related staff.
- Strengthen the evaluation and supervision capacity.
- Implement the whole inspection process responsibility.
- Establish the professional inspection teams.
- Strengthen the team organization
- Strengthen the cooperation
- Properly publicity and explanation.