Reform should encourage drug innovation - members of the Standing Committee of the National People's Congress to consider the two drug reform pilot related decisions:

November 2, October 31 is being held at the 17th meeting of the Standing Committee of the 12th National People's Congress on the 31st sub-group to consider the "Decision on authorizing the State Council to carry out the drug market licensing system pilot and drug registration classification reform pilot work (draft)." Members of the Standing Committee of the National People's Congress put forward opinions and suggestions on the draft, saying that the reform should encourage drug innovation and improve the quality of medicines.
, the State Council is authorized to organize a pilot drug market licensing system, allowing drug research and development institutions and researchers to obtain drug approval numbers and assume corresponding responsibilities for the quality of drugs.
", the State Council to carry out the drug market license holder system pilot and drug registration classification reform pilot work, is a very important initiative. Liu Depei said that china's current drug market management is mainly through the transfer of technology, this model for research and development institutions and researchers of the enthusiasm of the mobilization is not high, and then it is easy to produce a low level of duplication. According to international experience, developed countries are mainly using the drug market licensing, holder system. After china's reform and opening up over the years, especially after the implementation of major special projects of new drug creation, the level of research and development has been relatively large, drug production capacity is constantly improving, and the pharmaceutical industry specialization division of labor has been gradually formed, so this pilot is imperative.
reform of the "property market" listing licensee system is an innovation. Commissioner Cong Bin said that this is mainly reflected in encouraging the innovation enthusiasm of the real innovation team, encouraging the innovation enthusiasm of the natural person of the real innovation subject, rather than the previous emphasis on the enterprise is the main body of innovation, regardless of the state of the enterprise, which limits the innovation and development of science and technology personnel. He suggested that since the birth of innovative drugs is closely related to the work system and evaluation indicators of the Drug Review Center, the work system of the Drug Review Center should be standardized, scientific and transparent as far as possible, avoid artificial randomness, and boldly accept the public's supervision of drug review experts.
"Because a drug is really applied to the clinic, there are two stages of development and production, research institutes or individuals holding a license approval or still have to dock with enterprises." How to dock, docking policies and measures should keep up. Commissioner Chen Weiwen suggested that the requirement in the draft that "to allow drug research and development institutions and researchers to obtain drug approval numbers and bear corresponding responsibility for the quality of drugs" should be changed to "corresponding responsibility for the quality of drugs" to "corresponding responsibility for the quality of drug development", because drugs enter the production stage, if quality problems are found, production enterprises should be investigated, the draft decision should be as clear as possible to avoid differences and disputes in the implementation process.
drug registration classification reform pilot submitted for consideration this time mainly aimed at improving the quality of generic drugs. The draft stipulates that the State Council shall be authorized to organize a pilot reform of drug registration classification in the field of chemicals, and temporarily adjust the "drugs with existing national standards" stipulated in the Drug Administration Law to "drugs consistent with the quality and efficacy of the drugs originally studied".
" development of generic drugs is an important way to solve the people can buy, affordable drugs, but also the international practice. Commissioner Bai Zhijian said that our country is a big country of generic drugs, but due to standard management problems, the quality of generic drugs is generally not high. This reform from the past "imitation of existing national standards of drugs" adjusted to "imitation of drugs consistent with the quality and efficacy of the original drug", will greatly improve the standard of drug approval, improve the quality of generic drugs, to solve China's generic drugs "more and more imitation is not like" problem. But whether high-quality generic drugs can develop healthily in Our country depends on the improvement of pharmaceutical policies such as product standard system, approval, pricing and bidding.
he suggested that in the pilot process, we should also speed up reforms in the pharmaceutical sector and build a platform for the development of high-quality generic drugs. "The above two system reforms cover a wide range of issues, especially many supporting regulations need to be adjusted accordingly. Therefore, it is a pragmatic and practical attitude in favour of piloting first, exploring the feasibility of the system through piloting, gaining experience and then initiating legal amendments. Commissioner Bai Zhijian said. (State Administration of Food and Drug Administration)