Drug Medical Device Reform Program Comes Out

Many kinds of "big problems" in the pharmaceutical industry will be solved.　　Many kinds of "big problems" in the pharmaceutical industry will be solved On August 18, the Chinese government published the Opinions of the State Council on Reforming the Review and Approval System for Medical Devices Drugs (hereinafter referred to as "Opinions") The Opinion proposes to strictly control the approval of the market supply of drugs that exceeds the demand for drugs Strive to digest the backlog by the end of 2016, as soon as possible to achieve the registration application and review of the annual access balance, 2018 to achieve the required time limit approval opinion, said that China's pharmaceutical medical device
sadmission s approval of the problems in the examination and approval of the increasingly prominent, the quality of registration application information is not high, the review process needs to be supplemented and perfected many times, seriously affecting the evaluation and approval efficiency; at a press conference, the State Food and Drug Administration Deputy Director Wu Wei admitted that the National Drug Review Center is under review of 21,000 drugs, all the backlog of drugs, 90% of the generic drugs, more than 80% of the chemical drugs are generic drugs, the threshold of generic drugs is low, the declaration volume is large, according to statistics, more than 100 varieties involved in the declaration of more than 2000 pieces drug approval standards to improve the innovation ability of enterprises is weak, the policy should improve the enterprise's research and development capacity to find a way "Opinion" said that "to carry out a pilot system of drug market licensing holders", allowing drug research and development institutions and scientific research personnel to apply for registration of new drugs, in the transfer to the production of enterprises, only the production enterpriseon on-site process verification and product inspection, no longer repeated drug technical review also proposed to this end, to speed up the revision of laws and regulations, timely sum up the pilot system of drug market licensing holders, drug registration classification reform pilot progress, promote the accelerated revision of the Drug Administration Law of the People's Republic of China, combined with the reform of the administrative examination and approval system, and urgently revise the Regulations on the Implementation of the Drug Administration Law of the People's Republic of China and the Measures for the Administration of Drug Registration in accordance with the procedures compared with other industries, pharmaceutical industry is a high-risk industry, on the one hand, the new drug research and development cycle is long, expensive, on the other hand, even if the new drug market, there may not be enough market recognition rate In addition, even if the problem of drug research and development is solved, it is possible that many enterprises can not afford the construction of production bases and so on drag on industrialization, which makes it difficult for domestic research and development teams to survive the industry's accepted approach is CMO (pharmaceutical contract outsourcing), but at present, CMO in the domestic has been facing a policy of tight spells Under the existing laws and regulations, the drug listing license and production license adopt a "bundled" management model, and the drug approval number is only issued to the production enterprises with the "Drug Production License" This means that research and development drug companies must build their own plant, in order to complete the entire process of industrialization of new drugs, so this policy urgently needs to be loosened many places are also looking for opportunities to pilot Zhangjiang Pharmaceutical Valley, for example, in June 2013, it and the German pharmaceutical giant Bollinger Ingeheim jointly built cMO (Pharmaceutical Contract Outsourcing) biopharmaceutical base, the project launched last June, the proposed investment of 500 million yuan according to the aforementioned pharmaceutical company research and development person in charge of the statement, "opinion" there are many bright spots: the formation of specialized technical review project team, the full disclosure of drug medical device review and approval information, the counterfeiters to carry out severe punishment, there are many enterprises need to further clarify the issue, for example, the specific rules of the evaluation of the consistency of generic drugs is how (Responsible Editor: DF150)