After the National Day holiday, the General Office of the State Council issued the Opinions on Deepening the Reform of Examination and Approval System to Encourage the Innovation of Drugs and Medical Devices. The pharmaceutical industry ushered in a hot, rapid development of the pharmaceutical industry, especially for the reform of clinical trial management :
(A) clinical trial institutions eligible to implement the record management.
(2) to support clinical trials and personnel to carry out clinical trials.
(C) improve the ethics committee mechanism.
(Iv) improve the efficiency of ethical review.
(5) to optimize the clinical trial approval procedures.
(6) to accept overseas clinical trial data.
(Vi) support for extended clinical trials.
(8) serious investigation and prosecution of data fraud.
All the policies are on the new drugs and generic drugs listed to speed up the rhythm, especially in China after joining ICH, the new drug is expected to global synchronization listed.
And cancer as the current impact on national health, the greatest threat to the development of anti-cancer drugs and the market has been concerned about the anti-cancer targeting drugs because of its highly selective to kill cancer cells, while rarely damage the characteristics of normal cells, Anti-cancer first-line drugs.
Asiatic drugs as a representative of anti-cancer targeted drugs, since 2001, imatinib since the market, the development of tini drugs continue to be hot, as the pharmaceutical companies competing to get involved in the field.However, as of now approved There are only 15 drugs (13 imported and 2 domestic) .There are a number of imported tiemi drugs that have not yet been approved for listing, but have started clinical trials in China.
Some developed countries as early as a few decades ago to break the pathogenesis of cancer, 'capture cancer' has now seen some of the results of the current level of cancer treatment in China and these countries there is a certain gap, the most intuitive is foreign New drugs in the domestic market time is too late.
China's pharmaceutical industry has entered a stage of rapid development, foreign drugs can not be done in the domestic I re-apply for clinical trials, can be synchronized in the global multi-center clinical trials, conditional recognition of foreign drug clinical trial data. So that patients can have more opportunities to participate in the global clinical trials of new drugs.
For me as BDer, the more is the opportunity to find new drugs in the world license in.
