Focus on the two sessions: sun piaoyang of Hengrui medicine: the two sessions put forward these suggestions

Source: Hengrui pharmaceutical, known as "R & D first brother" on March 6, 2018, is a typical endogenous growth enterprise, focusing on innovation, production and business development In November 2017, Hengrui pharmaceutical became the first pharmaceutical stock with a market value of more than 200 billion yuan, which made the industry see the return of innovative research and development At the Symposium of CPPCC members of the 10th "voice and responsibility" pharmaceutical people's Congress in 2018, sun piaoyang, deputy to the National People's Congress and chairman of Hengrui pharmaceutical, put forward his suggestions on the new situation of drug regulatory reform and improvement of drug innovation and R & D Sun piaoyang said that the pharmaceutical industry is entering a new era, which is mainly due to the great importance attached by the CPC Central Committee and the State Council to the reform of drug supervision The State Administration of drug administration implements the four most stringent requirements of the CPC Central Committee, strengthens the supervision of the whole process of drugs, promotes the reform and innovation of the drug review and approval system, and promulgates a series of policies and measures The top-level design, involving all aspects of drug research and development to the market, pays attention to all aspects of the opinion, has been generally approved and supported, and has achieved remarkable results In the new era, the drug regulatory system has three new characteristics: 1、 New direction: the State implements the strategy of innovation and development and the strategy of healthy China, adheres to the people-centered, and adheres to the guidance of encouraging innovation and improving quality Since 2017, the state issued 36 opinions on deepening the reform of the review and approval system and encouraging innovation, the reform measures have pointed to the pain points, faced the difficulties directly, and met the period of the people's drug reform It will adapt to the trend of global industrial development and provide a new lever and direction for the development of Chinese medicine in the new era 2、 New standards: on the one hand, according to the international standards, the state evaluates the consistency of generic drugs; on the other hand, the overall drug review and approval is also carried out according to the international standards, especially since China joined the ICH in 2017, which will further help the reform of the drug regulatory system and promote the development of the industry 3、 New achievements: through the reform, the problem of drug registration backlog has been well solved; a number of generic drugs have passed the consistency evaluation; and the speed of new drug review and approval, application for clinical registration, and new drug production registration has been greatly accelerated In October 2017, the general office of the CPC Central Committee and the general office of the State Council issued the opinions on deepening the reform of the review and approval system and encouraging the innovation of drugs and medical devices, including the reform of clinical trial management (the filing system is implemented for the qualification identification of clinical trial institutions), the acceleration of market review and approval (the implementation of the related approval of drugs and pharmaceutical raw and auxiliary materials and packaging materials, the support of traditional Chinese Medicine Inheritance and innovation) New), promote drug innovation and generic drug development (establish drug listing catalogue set), and promote the full implementation of listing permit holder system, etc The reform of the pharmaceutical industry is strongly supported by the policy, but there are still many details to be solved Sun piaoyang suggested: 1 Continue to encourage the development of clinical trials of new drugs to implement the 60 day licensing system of clinical trials of new drugs (ind), strengthen the supervision of clinical trials, and truly realize the clinical application of drugs without opinions in 60 days We will implement the provisions of reform, such as the technical guidelines for the application of new drug phase I clinical trials, and allow enterprises to continuously improve and modify data, and establish a review system suitable for new drug development Implement the recognition of overseas data, and promote enterprises to integrate global resources for domestic registration 2 Continue to optimize the new drug market review and approval process can follow the US FDA system, gradually change the current situation that every generic drug must be reviewed, save administrative resources, and speed up efficiency During the review and approval process, the production site inspection and clinical experiment site inspection can be carried out simultaneously, saving the review time For the conditional approval of new drugs, a specific process and requirements for rolling submission of data can be introduced, which is convenient for enterprises to follow 3 Establish data protection suitable for national conditions and actively improve innovation enthusiasm With the difficulty of new drug R & D and the increasing investment, the R & D cycle is longer and longer Data protection and patent extension can make up for the lack of patent period after new drugs are put on the market to a certain extent, and better encourage the enthusiasm of entrepreneurs When establishing the data protection system, we should take into account all aspects of the situation, including new dosage forms, new indications and other clinical values Advantages 4 Strengthen the publicity and guidance of drug regulatory reform policies, establish the necessary transition period, before the formal release of the reform policies, it is suggested that the regulatory internal general publicity and implementation reach a consensus, timely respond to the attention of the industry to the policies, and consider the social opinions For example, the related approval system of the original auxiliary drugs has a great impact on the research and development of drugs There are many puzzles and contradictions in the specific implementation process We hope that regulators can increase the channels of dialogue on hot issues For example, can enterprises reach an agreement on all aspects of existing policies? Does the enterprise have a good understanding? At the same time, the drug R & D and registration cycle is relatively long, and the environment is relatively diverse It is necessary to fully consider the transition period of the implementation of various reform policies, so that the industry can learn and digest the policy, adjust the R & D plan, and avoid repeated investment Sun believes that through the reform of the national drug regulatory system, the core competitiveness of pharmaceutical enterprises will return to innovation ability and product quality in the future, and the phenomenon that bad money drives good money will be corrected In the global industrial pattern, both R & D innovation and market development are a game of chess at home and abroad For enterprises with international vision and the ability to integrate global resources, they will win more long-term voice.