After decades of hard work, a drug regulatory system that conforms to the development law of the drug industry and meets the public's needs for safe and effective drug use has basically been formed. The author believes that the future development of drug supervision will show a more accurate, transparent and efficient trend on the basis of the existing system.

Increased proportion of technical supervision

The continuous advancement of science and technology has made new technologies and new processes more widely used in the pharmaceutical industry, but this application has both legal and illegal applications. Therefore, the proportion of technical supervision in the process of drug supervision will continue to increase, and it will gradually transition from a supporting role to an important part of supervision, so as to adapt or promote the legal application of new technologies in the development of the pharmaceutical industry and combat illegal applications.

⒈ The drug standard system is continuously improved

Since its establishment in 1953, the Pharmacopoeia has had ten editions. Since 1985, it has been revised every five years. Each revision will add new drugs and raise new standards. In the future, the 5-year revision system of the Pharmacopoeia will continue, and each revision will be carried out in accordance with the latest and strictest technical requirements, and more drugs will be included in the Pharmacopoeia.

At the same time, a large number of the latest research results and supplementary testing methods formed by exploratory testing will continue to be supplemented and improved in the revision of the Pharmacopoeia and the revision of drug standards. In addition, the revision of other drug standards not included in the Pharmacopoeia has also been gradually normalized and institutionalized. The continuous improvement and enforcement of standards will continue to increase the safety and effectiveness of medicines, and will also provide more possibilities to combat and prevent technical fraud by exploiting standard loopholes and lag. The formulation and revision mechanism of drug standards will also change. More scientific research institutions, inspection institutions, colleges and universities and other technical organizations will participate in the formulation and revision of standards using more clinical practice and verified data.

2 The quality management system escorts the sea

The management standard system composed of GMP, GSP, GLP, GCP, GAP, etc., was implemented in my country in the 1980s, which greatly promoted the development of the pharmaceutical industry and the improvement of the quality level. In the future, the quality management system will strictly revise the quality management practices and add appendices in accordance with international drug quality management standards and technical requirements, strictly implement certification and post-certification follow-up inspections, and adopt a combination of "dual random" and unannounced inspections to continuously increase the quality of the products. Great implementation efforts will truly realize the comprehensive and standardized management of drug quality from a technical point of view.

3 The monitoring effect of adverse drug reactions is effectively exerted

In the future, the reporting channels for adverse drug reaction monitoring will be more extensive. In addition to the direct reporting points and sentinel institutions of professionals, the public platform for the society will be opened. The power of adverse reaction reporting will continue to expand, and the people involved in reporting are no longer limited to regulatory and medical technicians, and more pharmaceutical companies and drug consumers will participate. The review of adverse reaction reports has been continuously rigorous, and the screening rate of valid data has been greatly improved. The application of adverse reaction monitoring results continues to deepen, not only providing timely and accurate information for the control of harmful consequences such as market suspension and recall, but also feeding back monitoring data to production enterprises, research institutions and standards revision departments.

4. Drug sampling test has a stronger supporting effect

As the most effective method for supervising the quality of post-marketing drugs, the intensity of drug sampling inspection will continue to increase, and the increased investment and planned volume of sampling inspection will be more suitable for the regulatory needs of marketed drugs. The subdivision support function of the random inspection function is more obvious, and the evaluation function of the national random inspection plan will emphasize the coverage sampling of the same batch of varieties in the whole region and all links. The supervisory function of the local inspection plan will place more emphasis on the pertinence of the inspection. Combined with law enforcement inspections, the varieties with questionable quality on the market will be extracted as much as possible for individual inspection. Non-standard research inspections have gradually become the norm, mainly for research inspections that use standard defects to illegally add and substitute. More inspection agencies will carry out more varieties. The release of drug quality announcements is more timely, important announcements are released in real time, and general announcements are released more frequently. Inspection results have an increasing impact on regulatory decisions, and inspection big data will adjust and change the focus and direction of supervision.

5 "Internet +" deepens the idea of ​​supervision

The application of information technology in drug supervision is becoming more and more extensive, the intelligence of the development and application of the information-based supervision platform has been continuously improved, and more supervision elements have been developed into software and installed in the system. With the enhancement of information-based supervision capabilities, the Internet trade of medicines will be further liberalized. The effective docking of data supervision with enterprise information has become possible, collecting real-time quality control information about the production and operation of enterprises in accordance with the law, using the system to automatically analyze and compare, and respond to release, warning or further regulatory measures. The Internet push of regulatory information is more, faster, and more real-time, which is convenient for the public to understand the drug regulatory situation at the first time. The nationwide drug informatization supervision network has been gradually constructed, and the full-process control of varieties and the supervision of the whole chain of links have become a reality in the true sense.

The pattern of social co-governance is gradually formed

6 Complaints and reporting systems become the main platform

In January 2011, the Complaint and Reporting Center of the State Food and Drug Administration was officially put into operation. dispose of. The Measures for the Administration of Food and Drug Complaints and Reports (for Trial Implementation) and the Measures for Rewards for Reporting of Illegal Behaviors in Food and Drugs have been issued successively to regulate the content, procedures and rewards of reporting.

The construction of channels should be more convenient for complainants and whistleblowers, and make full use of the Internet to build a platform, so as to be easy to operate, visible everywhere, and available at any time. Complaints and reporting procedures should be more standardized, handling more timely and accurate, complaints must be accepted, reports must be received, reports must be checked, and inquiries must be responded to. The reward system for complaints and reports will continue to be implemented, so as to achieve the best possible rewards.

7 Integrity system helps drug supervision

With the establishment and improvement of the social credit system, the production and operation of pharmaceutical companies in compliance with laws and regulations has increasingly become a factor for measuring the integrity of the company. Create a relatively independent and complete integrity system for pharmaceutical companies, improve the integrity evaluation and early warning mechanism marked by the "blacklist" system, use more supervision results as a direct basis for integrity judgment, and further refine the specifications. Scientifically divide the level of integrity, and take the lead in applying the integrity of enterprises to regulatory matters such as drug registration approval, production and operation license certification, and administrative penalties.

8 Insurance services will become a strong force

With the continuous development of the insurance industry, insurance products related to drug safety, such as drug enterprise insurance, drug product insurance, and drug safety liability insurance, have been launched continuously, and more and more drug companies have been served. In the process of formulating future drug legislation and regulatory policies, the status and role of this service in supervision will be clarified, and mandatory guidance and regulations will be provided.

9 Effective penetration of legal services

With the acceleration of the rule of law process, lawyers' legal services have increasingly entered people's daily lives and penetrated into all aspects of society, playing an increasingly important role in maintaining the correct and effective implementation of drug laws and regulations and serving the public's safe and effective drug use. Lawyers provide legal services in various aspects such as administration, business, and rights protection. On the one hand, they help clients meet the legal requirements of drug supervision; In different directions, we have strongly promoted the improvement of the administrative capacity and level of the regulatory authorities in accordance with the law.

In addition, the industry self-discipline organized by the pharmaceutical industry and the pharmacist and pharmacy services that accompany the drug life cycle will become an indispensable and important part of the formation of the drug co-governance pattern and play an important role.

(Jilin Qijian Biotechnology Co., Ltd._Biopharmaceutical_www.qjbio.com.cn)