On October 22, 2020, the draft amendment to the Drug Administration Law was submitted to the Standing Committee of the National People's Congress for deliberation. Previously, the former State Food and Drug Administration solicited public opinions on the Amendment to the Drug Administration Law of the People's Republic of China (Draft for comment), which was widely concerned by the industry and expected by the industry. Since the reform of the drug review and approval system was launched in 2015, the idea of regulatory reform to combat data fraud, solve the review backlog, encourage innovation, improve drug quality, and create a balanced imitation is gradually clear. A series of innovative systems and reform measures have been introduced and implemented, and the comprehensive revision of the Drug Administration Law has been accelerated.

Since the implementation of the Drug Administration Law in 2001, China's pharmaceutical industry has undergone great changes: the total output value of the pharmaceutical industry has increased from 0.21 trillion yuan in 2001 to 3.24 trillion yuan in 2016. At the same time, the proportion of the total output value of the pharmaceutical industry in GDP continues to rise, from 1.93% in 2001 to 4.35% in 2016, and the status of the pharmaceutical industry in the national economy has steadily improved. At the same time, the safety, effectiveness and accessibility of medicines to patients have improved dramatically, and many serious life-threatening diseases now have drugs. This is encouraging progress.

When the current Drug Administration Law is issued, in terms of the concept and the revision of specific clauses, it is considered to have unprecedented progress, which also embodies the active implementation of our country's entry into the WTO related to the drug commitment. Under this standard, the pharmaceutical industry has made great progress. However, in the current drug regulation, it is found that the review and certification, strict supervision and punishment, which were considered strict at the time, are now less effective. This also fully corroborates "the law from the moment it is enacted, has fallen behind". With the rapid changes of The Times, drug safety regulation is faced with many challenges from globalization, scientific and technological progress and information technology, and the increasing health needs of the public. Therefore, the regulatory concept, regulatory means and regulatory measures need to be timely adjusted to keep pace with The Times.

Drugs are never perfectly safe. Drug safety is always about balancing risks and benefits for potential users. The job of drug safety regulation is to control risks and increase benefits. The legislative purpose of the current Drug Administration Law includes the expression of "ensuring the quality of drugs, ensuring the safety of drug use, and safeguarding people's health and legitimate rights and interests of drug use". But a study of the laws and policies of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) reveals a quiet shift in regulatory philosophy. The EU has enshrined the protection and promotion of public health in the Medicines Directive. The FDA's official statement of its mission is also to protect and promote public health.

If a careful analysis, we can find that the above expression of the concept of different points of landing. Ensure focus on "product", protect focus on "health". Ensuring the safety, effectiveness and quality of drugs is the responsibility of regulators and the basic obligation of enterprises. Warranties are limited warranties based on past experience, whereas protection and promotion are unlimited protection and promotion, with the theme of "controlling risk". Risk and safety are the characteristics of drugs. They are the unity of opposites and are associated with the whole life cycle of drugs.

The FDA points out that drug safety incidents, large and small, occur every day, and the agency is structured to deal with emergencies large and small. In the United States, drug risk warnings, recall information and warning letters are issued almost every day, and the public and society tend to have a rational cognition of drug safety, rather than blindly pursuing absolute safety of drugs, but learning scientific decision-making and judgment, and looking at drug safety more rationally.

The regulatory concept of protection and promotion focuses on public health, considering and evaluating risks and benefits from the perspective of potential users of drugs. The most effective way is not to ensure safety, but to control risks. Risk is a loophole, risk management is to find regulatory loopholes, plug regulatory loopholes. Therefore, risk management should be taken as one of the core principles of the revision of the Drug Administration Law. Fault-tolerant mechanisms should be established in the pharmaceutical industry, and companies should be allowed to establish strong quality systems, assume primary responsibility for risk control, and take legal obligations and responsibilities in cooperation with regulators rather than confrontation.

It can be predicted that with the deepening of drug regulatory reform and the reform of the medical and health system, the future revision of the Drug Administration Law will strengthen four key points:

One is to create imitation equilibrium.

China is a big producer of active pharmaceutical products, but it is not a strong producer of pharmaceutical products, still less a strong innovator. Imitation balance is an important part of the future reform of drug review and approval system, which will also be reflected in the future revision of the Drug Administration Law. That is to say, a series of institutional arrangements related to encouraging innovation, balancing imitation and ensuring supply will be introduced, such as priority review and approval system, patent link system and supply guarantee system.

Second, streamline administration and delegate power.

The market authorization holder system is the basic system and the core system, which will become a main line in the revision of the Drug Administration Law. Only under the marketing authorization holder system can reforms such as streamlining administration, delegating power and simplifying licensing be implemented. After the implementation of the marketing authorization holder system, the regulatory approach of the pharmaceutical industry will no longer mainly rely on approval and certification, but establish a mechanism to advocate that enterprises bear the main responsibility and industry self-discipline, while supporting flexible and efficient regulatory systems, such as implied licensing, filing (registration), risk-based inspection, responsibility interview, blacklist, industry ban, etc. This will make regulation more cost-effective and enable enterprises to play a dominant role in the market and take the initiative to undertake legal obligations, responsibilities and social responsibilities.

Three is the "four strictest".

The "four strictest" requirements will be incorporated into the provisions of the Drug Administration Act. "The most rigorous standards, the most stringent supervision, the most severe punishment, the most serious accountability", these four "strictest", in the State Medical Products Administration just announced the punishment results of Changchun Changsheng Biotechnology Co., LTD., we have deeply experienced - a huge fine, directly responsible personnel and personnel in charge will be investigated for criminal responsibility. It can be predicted that in the future, the legal liability part of the Drug Administration Law will set a more severe punishment, no matter the administrative responsibility, criminal responsibility setting, or adding the punishment to the person clause, will reflect the "four strictest". More punitive measures will also help curb illegal activities.

Fourth, the whole life cycle management.

Drugs are special commodities, and the supervision of drugs should be carried out through the whole life cycle, the whole supply chain and the whole process. The marketing authorization holder shall undertake the obligations and main responsibilities of safety and effectiveness management for the whole life cycle from pre-listing to post-listing. Full life cycle control is the continuous assessment of risk and benefit before and after listing. The whole supply chain control of drugs requires the marketing authorization holder to carry out strict quality audit on the original and auxiliary suppliers. The whole process control is to carry out process control through the implementation and inspection of quality management standards such as GLP, GCP, GMP and GSP, and supervise the compliance of enterprises.

The revision of Drug Administration Law is a huge systematic project, which aims at protecting and promoting public health by transforming the idea of supervision into a foothold. In the revision of Drug Administration Law, the system of marketing authorization holder is the core and main line. At the same time, the whole life cycle regulation of drugs is a multi-agent process. Therefore, it is necessary to find the key participants and responsible persons in each link, fulfill the responsibilities, and share the risks.

来源：

《中国医药报》文/杨悦，沈阳药科大学国际食品药品政策与法律研究中心教授、博士生导师。