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Reduce the number of drug registration 2 / 3 to encourage innovation is the main theme

Reduce the number of drug registration 2 / 3 to encourage innovation is the main theme

From September 10 the State Food and Drug Administration (SFDA) held a regular press conference was informed that, in recent years, China's drug registration applications reduce the number of years, declared 2 / 3, with the variety of reporting a reduced rate from 1:6 : 3, indicating that the trend of China's drug registration to declare turning point, a gradual return to rational drug registration. And to encourage innovation has become the main theme of drug registration and regulation system.


SFDA drug registration Secretary Zhang at the press conference The announcement was made several sets of data:

From October 1, 2007 to the end of June this year, SFDA received a total of 4403 applications for registration of medicines, the annual reduction in the number declared 2 / 3; of these, 84 new medicines, generic drugs 1682.

The new "Drug Registration Management Measures" since the implementation of the same species reported, the ratio of 1:6 from 2006 down to 1:3 this year, Chinese medicine has been almost no duplication of reporting the phenomenon.

From the ratification of view, in 2009 1 June SFDA approval of new drug clinical applications 173; new drug product application 238, of which 8 a class of drugs, generic drug applications for 1074, 388 applications for import of drugs.

Zhang said that from these data we can see that the total reported significantly reduced drug registration, duplicate reporting reduced markedly improved the quality of the structure change. This fully shows the gradual return to normal drug registration, drug research and development increased in line with national conditions, the new "Drug Registration Regulations," the implementation of the correct orientation to achieve the desired outcomes.

Recalling the transition varieties of centralized review and approval of an inventory document number, etc., Zhang said that the management of drug registration to address outstanding problems, SFDA in accordance with the deployment of the State Council, actively and steadily carried out the pharmaceutical development of the special rectification work areas. 33000 drugs through the registration on-site verification, withdrew 7999 drug registration applications; through drug approval number inventory write-off of the 4337 ratification of the symbol; varieties through centralized review of the transition period to deal with the backlog of species of 25000 , which does not approve 15000 varieties, mostly for chemical drugs 5 / 6 classes, TCM 8 / 9 class, not to approve the rate of 61%.

Encourage innovation

October 2007 1, granted the revised "Drug Registration Management Measures" after the official implementation, SFDA has successively adopted a "Chinese Medicine Registration Supplementary Regulations", "on-site verification of drug registration regulations", "the special approval of the registration of new regulations." Recently, the transfer of technology to regulate the registration of drugs act to ensure drug safety, efficacy and quality control, according to "Drug Registration Regulations," the relevant provisions, SFDA issued a fourth implementation of the supporting documents - "Drug Registration of technology transfer regulations" .

Since then, the "Drug Registration Regulations" as the core of our legal system for drug registration initially formed, has entered a drug registration in China to encourage innovation, to guide new era.

Zhang said that encourage innovation, to guide innovation, which is reflected in numerous laws and regulations document, and mutual coordination and concerted efforts. First, the new revised "Drug Registration Regulations" strict the scope of a new drug, the issuance of the certificate to further enhance the gold content of the new drug certificate. Secondly, in the "special approval of the registration of new regulations", the early intervention through the adoption of a priority review, and multi-channel communication and dynamic measures such as supplementary information to encourage and support innovation in drug discovery. Third, the "on-site verification of drug registration regulations," provides for strict registration on-site verification and inspection requirements to ensure the authenticity of the information submitted to maintain the registration approval of the fairness and seriousness, so that all can truly down policies to encourage innovation into practice. Fourth, in the "Chinese Medicine Registration Supplementary Regulations" in order to encourage the new Chinese medicine indications in the new functional areas of R & D, for "there is no effective treatment for the treatment of diseases of the drug means" to increase connotation of "the main medical treatment card is not in the state-approved Chinese medicine 【Indication】 contained in the received drugs "into the specific approval of the scope, and to take concrete measures to broaden the group of Chinese herbal compound preparation of the content side. Fifth, the "Drug Registration of technology transfer regulations," after the introduction of right to further encourage innovation, promote the rational allocation of resources will play an important role.