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

Published on:

2023-03-02

Beijing, 18 Aug (Xinhua) -- Against the background of comprehensively deepening reform and streamlining administration and delegating power, the State Council issued the "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices," which released a strong signal to streamline administration and delegate power in the pharmaceutical field to accelerate the reform of the examination and approval system.

In recent years, China's pharmaceutical industry has developed rapidly, but due to problems such as low drug approval standards, backward management methods, and unreasonable institutional mechanisms, many drugs that need to be approved for approval for review have accumulated for a long time, making patients in urgent need of treatment and pharmaceutical companies submitted for review dissatisfied. The data shows that there are more than 20,000 backlogs waiting for review and approval in the National Drug Evaluation Center, and there is a big gap between the number of drug approval reviews and the improvement of people's livelihood, people's needs and the expectations of pharmaceutical companies.

It should be noted that the reason why a large number of approvals are backlogged, although there are many objective factors such as a large amount of tasks and a small number of manpower, but people can also find that there is still a lot of room for streamlining administration and delegating power and reforming the administrative system and mechanism. Taking advantage of the State Council's issuance of opinions, it is timely to further streamline administration and delegate power, accelerate the reform of the pharmaceutical examination and approval system, and establish a scientific, reasonable and standardized examination and approval system.

At the same time, it should also be noted that the field of drug approval and its complicated links were once a corruption-prone area, and Zheng Xiaoyu, former director of the State Food and Drug Administration, Cao Wenzhuang, former director of the Department of Drug Registration, and Chen Haifeng, former head of the drug evaluation department, have fallen on the "approval line", which is a painful lesson. In the course of reform, on the one hand, it is necessary to establish a scientific, rational and strict examination and approval mechanism system, and also strictly prevent the occurrence of new corrupt behaviors such as "closing the door for examination and approval" and "eating and taking cards", so that the alarm bell of anti-corruption and anti-corruption will sound for a long time.

At present, China is in a critical period of comprehensive deepening reform, and the review and approval system for drugs and medical devices is part of the reform of the administrative system and the transformation of government functions. At the beginning of the establishment of the current government, the first thing to do is to promote the reform of the administrative system, transform the functions of the government, and take the combination of simplifying administration and delegating power and management as the "first hand chess", which is the need and necessity for the country to promote the construction of a people-oriented, beneficial and vibrant government administrative system and mechanism.

To resolutely eradicate the "root" of corruption in the field of drugs and medical devices, on the one hand, it is necessary to further simplify administration and delegate power, rationalize and improve the power and responsibility system and system of relevant departments such as medicine, so that the power of pharmaceutical examination and approval can be strictly regulated and restricted, so that it can operate under the sun; On the other hand, it is necessary to put power into the cage of the rule of law, strengthen the supervision of the examination and approval process, so that the "hidden rules" of medicine have nowhere to hide, prevent the breeding and spread of corruption from the source, and thoroughly reform the old institutional mechanisms that are not suitable for economic and social development, so as to truly achieve the goal of improving the problems of "difficult to take medicine, expensive medicine, and low quality medicine" and enhancing the people's "sense of gain".

Responsible Editor: Lei Lina

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