Drug administration focus should move to production

Today's people are no longer hungry or cold due to lack of food and clothing, but they are guilty of seeking medical advice because they gullibly advertise for fake health products. They are no longer killed for lack of medicine, but often face drug safety problems. Over the years, the drug regulatory department has done a lot of work, but since 2006, a series of major drug-related incidents (also known as drug safety incidents) have made us realize the importance of source supervision. The transformation of the regulatory model may not eliminate the occurrence of drug-related incidents, but monitoring the production process can reduce the incidence of drug-related incidents.

Pharmaceutical Supervisors Should Be Given Greater Responsibility in the Transition Period

Market chaos, regulatory failure, and lack of integrity are enough to cause frequent occurrence of drug-related incidents, but the deeper reasons come from the correlation between the degree of social and economic development and the frequent occurrence of drug-related incidents. Social industrialization promotes the growth of social GDP per capita and promotes the change of residents' consumption structure in the region. However, the industry's original mass production model has greatly increased the risk of public goods, especially foods, medicines and other special products. According to statistics, when the per capita GDP is less than 1,000 US dollars, the consumption structure is survival type, and there are relatively few cases of drug injury; when the per capita GDP is between 1,000 US dollars and 3,000 US dollars, the consumption structure shifts from survival type to development type, and the drug injury incident is in a high trend. When the per capita GDP exceeds 3,000 US dollars, the consumption structure tends to be stable, and the occurrence of drug-harm incidents tends to be gentle. This is an objective law that cannot be evaded. It is difficult to avoid elimination and it cannot be allowed to develop.

At present, China is in a critical period of economic and social transformation. There are a large number of drug safety risk factors, and the incidence of drug injury incidents is higher than in any previous period. In recent years, major drug-related incidents have been exposed from the use of links, but the root cause is in the production process, and it also exposes loopholes in the drug surveillance work.

In order to strengthen the supervision of drugs and ensure the quality of drugs, the Drug Administration Law and other related laws and regulations give pharmaceutical supervisory authorities the responsibility to supervise and administer drugs, which gives the drug regulatory authority an obligation. If the executive authorities are obliged to exercise their supervisory authority, they have the responsibility of violating the law. In the field of medicine, there is information asymmetry between consumers and producers and operators due to differences in professional knowledge. The public has no ability to discriminate against special commodities such as pharmaceuticals and foods. It completely relies on administrative supervision, and the obligation of administrative agencies to ensure safety becomes a strict obligation.

Drug regulatory model urgently needs to be transformed

The basic function of the supervisory department is risk prevention and risk management. At present, the difficulty in drug administration is: First, the regulatory power is not balanced. The focus of grass-roots supervision is in circulation, not in production, and pharmacy supervision is more powerful than pharmaceuticals. Second, the frequency of supervision is uneven. For some areas, multiple coverage, full coverage inspections, and other areas are almost blank. Third, the regulatory power is uneven. Law enforcement officers may be familiar with investigative techniques but are less knowledgeable about the drug production process. Fourth, the regulatory concept is not active. The supervisory departments often passively inspect and wait for cases, do not take the initiative to understand the situation of the enterprise, and simply pursue the number of cases handled (number of cases closed), the zero incidence of administrative inaction, and the outstanding rate of case law review.

Drug supervision (auditing) capability is a comprehensive expression of many aspects including regulatory style, regulatory philosophy, regulatory policy, and regulatory focus. The current shift in supervision and inspection of drug inspections should focus on improving drug regulatory capabilities, determine the focus of supervision, and make reasonable and detailed separation of supervisory authority between pharmaceutical supervisory departments at all levels so that the division of labor is orderly, cooperative, and effective, and thus effective Drug supervision. In response to the current drug regulatory situation and the arduous tasks it faces, the transition of the regulatory model for drug inspections should follow the following principles:

The implementation of risk management drugs is a special commodity, and there are inherent risks that cannot be fundamentally resolved and thoroughly avoided. In addition, the production and distribution process of pharmaceuticals is also a process of manufacturing and producing various “human risks”. There are many successful experiences of “risk management” across the country, and this management model has also been adopted by most departments. However, what needs to be noticed is that many of the “risk management” modes of work have become formal. For example, patterns such as charting and color marking have been imitated countless times, and “risk management” has not been implemented in details, but only Paper form and work summary.

Focusing on the production process, the supervision and customs clearance front-moving pharmaceutical supervision department undertakes the supervision responsibility from the production to the circulation and use of the drug. Regulatory work should be a dynamic and continuous process, in which regulation of circulation and use is an important means of ensuring the quality of drugs. Grasping the source, moving the quality control mark forward, and focusing on the supervision of the production process, is the essence of improving the quality of medicines. If the follow-up regulation of GMP certification is neglected, the phytotoxicity incident will not only be avoided, but will also intensify.

Raising the risk management of drug control in jurisdictions indicates a fundamental shift from passive to active drug regulatory models. The original crisis management and emergency plan focused mainly on disposal and recovery after the occurrence of drug injury incidents, and paid attention to the remedial management afterwards, but did not do enough on the real-time monitoring, forecasting and prevention work beforehand. When the drug risk is still at a potential stage, if there is a high degree of risk awareness and enhanced initiative, it will prevent or delay the transition of the risk to reality and try to minimize the risk. Even if there are still phytotoxic incidents, they can reduce the negative impact and losses.

Although the drug regulatory department is ultimately unable to reduce the risk to zero, it is obliged to promote the transition of the regulatory model for drug audits and to comprehensively use various regulatory measures to effectively prevent and control drug safety risks and reduce drug hazards.