New medicine, new rules
Guidelines help stimulate Shanghai’s innovation in medical fields
The Shanghai Municipal Government released 32 new guidelines relating to the city’s drug and medical enterprises on Wednesday, an attempt to further bring out these enterprises’ creativity and development, and to improve the city’s competitiveness in the drug and medical fields to the highest international level, according to the municipal government.
The guidelines focus on reforms in six aspects. One is about the reform of clinical test management. Local authorities have decided to allow foreign medical institutions to carry out clinical tests synchronously in Shanghai; it will also crack down on data fraud in clinical tests.
The second aspect of the guidelines is about accelerating the application of drugs and medical equipment on the market. Notably, drugs and medical equipment urgently needed by the market can now enjoy a “green channel” for faster approval.
The local authority also launched a one-stop service platform online, which allows enterprises to handle approvals online instead of visiting different government departments offline.
The third aspect of the guidelines is about turning Shanghai into a global leader in biological medicine innovation and research. A patent database of drug and medical equipment will be established for better patent protection. Companies are also encouraged to increase their investment in medical research.
Supervision and responsibility
Universities and medical research institutes are now allowed to keep most of the financial profits in their scientific findings. Some new drugs in cancer treatment and advanced medical equipment in overseas markets will be allowed to be applied into use in fixed points in Shanghai.
The fourth area is about tightening regulations and supervision on the full life cycle of drugs and medical equipment. Notably, a punishment system that traces back to specific individuals will be launched.
The guidelines also stress establishing new institutions, talent teams, data sharing system and promoting regional and international cooperation in the fields of drugs and medical equipment, to provide better technical and systematic support to the industry.
The sixth aspect is about the reform of government departments covering drug and medical equipment issues. Clear responsibilities will be allocated to related departments.