Medical network - March 20, on March 17, published by the state food and drug supervision and management of the administration of the administration of the state food and drug supervision and administration of imported drug registration management related matters about adjusting decision (draft) ". Put forward "the draft", to encourage overseas unlisted new drug approval in domestic and overseas synchronous conducting clinical trials, publicly listed company shorten the time interval, to meet the public demand for new drugs in clinical, for imported drug registration management related matters as follows:
A, in China with international multicenter drug clinical trials, cancel the clinical trials should be registered outside the People's Republic of China with medicine or has entered the stage II or III clinical trials, vaccine except drugs.
Two, for international multicenter clinical trials in China, after completion of the international multicenter clinical drug trial can be directly put forward listing application for registration of pharmaceuticals, Registration and listing shall be implemented by the drug registration management measures "and other related documents.
Three, for applying for import of chemical drugs and drug treatment with biological products innovation, cancellation shall obtain overseas pharmaceutical manufacturers in producing countries or regions listed licensing requirements.
Prior to the release of four, for the purposes of this decision, has been accepted by international multicenter clinical trial data without doing the import registration of clinical trials, in conformity with the requirements, can approve the import.
According to the requirements of the original imported drugs management method ", apply for registration of imported drugs must be producer drugs without the approval of the competent authorities registered and listed permission. To apply for not approed for sale in the domestic and foreign sales of imported chemicals (including Hong Kong, Macao and Taiwan), should at least have abroad entering phase II clinical trial of drugs.
According to the surging news on March 20, with the industry, said the past imported drugs to enter the Chinese market, on average, the review time need 3-4 years. , by contrast, the United States food and drug administration (FDA) on drug standard review time for ten months, and through the priority review of available time as long as six months.
Very high medical investment group business partner shu-guang wang said, "the draft" if you can implement, the short term, will effectively shorten the time to market, of imported drugs directly to Chinese patients; From a long-term point of view, will promote the clinical medicine, pharmaceutical industry, biological medicine science overall progress.
"From the draft state is of great determination." Shu-guang wang believes that "after the implementation of the New Deal, can promote rapid progress of new drug evaluation system in our country, and make China's pharmaceutical enterprises to the international level."
Shu-guang wang to further explain, as a result of various aspects reason, the state agency for imported drugs registration listed to be cautious in the past. If the current regulations: in China with international multicenter clinical trial of drugs shall be registered outside the People's Republic of China or has already entered a stage II or III clinical trials. And according to the provisions of the draft, a large number of foreign innovative drugs can enter clinical trials in China, greatly shorten the waiting time; While importing new drug applications don't have to wait for approval before at home abroad.
"Overall, the draft is adjusted on the basis of seeking truth from facts in science. Though it was within the reasonable, but still some unexpected heights. Also reflects the national agency for new drug development support confidence determination and technology. In the past a lot of new drugs and we can't review, don't even rate. The draft will be the agency for the country, especially in the implementation of the new drug trial department of technology put forward higher requirements, specific implementation need to be able to and the FDA to label." Shu-guang wang said.
"Draft" will solicit comments from the public, on April 20, 2017.
According to the epicenter wide net, "the voice of China reported eating jingquan, drug safety administration chief, has admitted that the domestic approval understaffed, objectively limits the speed of imported drugs listed. "We itself drug approval time is longer, less drug approval power. The United States center for drug approval, 5000 people last year through our efforts, at the end of last year to more than 600 people, it should be said that the efficiency of improved than before, but there is still gap. We are now through the optimization process, increase strength, gradually improve the efficiency of the examination and approval. So the backlog of drug approval has improved than before. The backlog of drug approval peak reached 22000 pieces, but at the end of last year reduced to 8000 pieces."
Nearly two years, the national food administration of drug safety has been done in terms of speed up the drugs listed many institutional attempt. At present, drug marketing authorisation holder system pilot in 10 provinces and cities. Under this mechanism, independent public license and production license. This means that drug research and development institutions can apply for drugs listed independently. After a lot of overseas drug firms and through set up r&d centers in China to speed up the drug approval.
Shu-guang wang with many years of drug research and development experience, has been paying close attention to the domestic new drugs development. He noticed that in recent 5 years, the national level of new drug review has made significant progress, from the administrative procedure into a leading to the review of scientific reasoning oriented.
China, on the other hand, as a generic power, overseas new drugs to speed up the market, is bound to profound influence on the domestic pharmaceutical enterprises.
Shu-guang wang said, this will be beneficial to optimization of the whole structure of the domestic pharmaceutical enterprises, to promote the integration of pharmaceutical enterprise mergers and acquisitions, would reverse the current domestic clinical data falsification rampant drug development, also will change the generics market channels for the king, and ignores the effect of deformity, "accelerate the imported drugs in the domestic market is very good elimination mechanism, can say in the future there will be a lot of drug firms will die, it is also a pharmaceutical giants to the inevitable trend of pharmaceutical power".
Imported drugs accelerate public policy once fall to the ground, what kind of the first batch of imported drugs will be on a New Deal express, is also the people are concerned.
Shu-guang wang said, there are two kinds of medicine will become a key to introduce objects: one is apt to domestic need, such as antitumor drugs, metabolism of drugs, antibody drugs, etc.; Another is domestic r&d level with the international gap larger drugs, including psychiatric drugs, such as high-end preparations. |
