On August 26, 2019, the newly revised "Drug Administration Law of the People's Republic of China" was voted and adopted at the 12th meeting of the Standing Committee of the 13th National People's Congress in December 2019. Effective from the 1st.
The specific systems of the Drug Administration Law mainly include:
First, it clarifies the direction of encouragement, focusing on supporting drug innovation that is oriented by clinical value and has clear curative effects on human diseases. Encourage the development of new drugs with new therapeutic mechanisms to treat serious life-threatening diseases, rare diseases, and drugs for children.
The second is to innovate the review mechanism, strengthen the capacity building of review institutions, improve the communication mechanism with registration applicants, establish an expert consultation system, optimize the review process, improve review efficiency, and provide drug innovation Organizational guarantee.
The third is to optimize clinical trial management. In the past, clinical trial approval was based on an approval system, which was changed to an implicit license system. The certification management of clinical trial institutions was adjusted to filing management, which improved the efficiency of clinical trial approval.
The fourth is to establish associated review and approval. When reviewing and approving drugs, chemical raw materials, related excipients, and packaging materials and containers that directly contact the drugs will be reviewed and approved together with the preparations. At the same time, drug quality standards, production processes, labels and instructions are also approved.
Fifth, priority review and approval has been implemented, and green channels have been opened for priority review and approval of shortage drugs in urgent clinical need, new drugs for the prevention and treatment of major infectious diseases and rare diseases, and medicines for children.
Sixth, a conditional approval system has been established. That is, for the treatment of serious life-threatening diseases for which there is no effective treatment, as well as drugs urgently needed for public health, clinical trials have data showing efficacy, and the clinical value can be predicted, the approval can be conditional, so as to increase the number of urgently needed clinical drugs. This system shortens the development time of clinical trials and enables patients in urgent need of treatment to use new drugs as soon as possible.