The reform of the pharmaceutical industry focuses on stimulating innovation vitality

Published on:

2023-03-02

While speeding up the review and approval, it is necessary to smooth the channel for innovative drugs to be included in pharmaceutical reimbursement. At the same time, relevant departments should encourage enterprises to increase investment in research and development and improve the standards and quality of drugs

The State Council recently issued the "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices", which clarified 12 reform tasks. As the first major adjustment of the review and approval system of China's pharmaceutical industry in the past five years, this reform not only solves the problem of a large backlog of new drug applications that has been criticized, but also focuses on improving drug evaluation standards, achieving drug safety, effectiveness and quality controllability, and promoting the structural adjustment and transformation and upgrading of China's pharmaceutical industry.

Some insiders pointed out that "slow" has become the biggest feature of China's current drug and medical device review and approval system. The long approval cycle has caused a serious imbalance between the number of drug registration applications and the number of approved documents, and many new drugs are blocked on the road to approval, unable to form economic and social benefits.

For pharmaceutical companies, whether they innovate depends on the judgment of the benefits of innovation. Most companies would rather seize the market in the highly competitive field of generic drugs than increase R&D investment in new drug creation. This reform starts from many aspects, focusing on building a review and approval system conducive to innovation, which will create an innovation environment in the pharmaceutical industry and stimulate the innovation vitality of pharmaceutical enterprises. In addition, by carrying out the pilot of the drug marketing authorization holder system and exploring the management mode of separating drug marketing authorization and production authorization, it will help developers concentrate funds and technologies for new drug research and development, reduce the problem of "duplicate research and development" caused by multiple transfers or segmented transfers, and then stimulate the innovation enthusiasm of drug R&D institutions and scientific researchers from the source and improve the quality of innovation.

In line with the principle of simplifying administration and delegating power, the reform strictly regulates and restricts the power of drug and device review and approval, clarifies the content and standards of approval, and discloses information on the approval process to form an open supervision of the review and approval behavior.

At the same time as industry reform, attention should also be paid to the fact that although the current review and approval system has many drawbacks, it also has a positive side in ensuring drug safety. Drug and device approval has its own internal rules, blindly pursuing the speed of approval without ensuring its quality, which is tantamount to encouraging seedlings. Therefore, how to speed up the approval speed under the premise of ensuring the quality and safety of drugs, improve the effectiveness and safety controllability of listed drugs, and solve the needs of the public for drugs is the ultimate goal of this reform.

In the process of reform, the application channel of domestic drugs should also be unblocked. Accelerating the review and approval is conducive to the expansion of domestic drugs, especially innovative drug production capacity, but at present, many innovative drugs entering the terminal market are constrained by some factors, especially entering the mainstream pharmaceutical market such as the medical insurance catalogue is limited by various factors such as the number of years on the market, the time limit for adjusting the medical insurance catalog, and the review system of the medical insurance catalogue in various places.

At the same time, relevant departments should encourage enterprises to increase investment in research and development and improve the standards and quality of drugs: on the one hand, they should increase financial support for high-tech enterprises; On the other hand, it is also necessary to reduce the tax burden of biopharmaceutical enterprises, and include clinical trial fees, purchase and use expenses of intangible assets in the process of drug research and development into the scope of super-deduction of R&D expenses. (Li Jialin)

Responsible Editor: Zhu Ying

Commentary: It is timely to accelerate the reform of pharmaceutical approval

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