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After decades of efforts, the drug regulatory system that meets the laws governing the development of the pharmaceutical industry and meets the effective needs of public drug use has basically taken shape. The author believes that the future development of drug regulation will show a more accurate, transparent and efficient trend based on the existing system.
Increased proportion of technical supervision
The continuous advancement of science and technology has made new technologies and new technologies more widely used in the pharmaceutical industry, but such applications have both legitimate and illegal applications. Therefore, the proportion of technical supervision in the process of drug supervision will continue to increase, and gradually transition from supporting role to important part of supervision to adapt or promote the legal application of new technologies in the development of the pharmaceutical industry, and to crack down on illegal applications.
1. The drug standard system is continuously complete
The Pharmacopoeia has been in full ten editions since its inception in 1953. Every five years since 1985, every time there will be a new drug increase, there will be new standards. In the future, the Pharmacopoeia will be renewed in the five-year system. Each revision work will be carried out in accordance with the latest and most stringent technical requirements, and more drugs will be included in the Pharmacopoeia.
At the same time, a large number of the latest research results, the supplementary test methods formed by exploratory testing and testing will also be continuously supplemented to the revision of the Pharmacopoeia and the revision of drug standards. In addition, the revision of other drug standards not covered by the Pharmacopoeia has gradually become normalized and institutionalized. Continuous improvement and enforcement of standards will continue to increase the safety and effectiveness of drugs, while also providing more possibilities to combat and prevent the use of standard vulnerabilities and lags in technical fraud. The mechanism for the revision and revision of drug standards will also change. More scientific institutions, inspection agencies, universities and other technical organizations will participate, and more clinically validated and validated data will be used to support standard revision.
2 quality management system escorts to the sea
The management norm system consisting of GMP, GSP, GLP, GCP, GAP, etc. was launched in China in the 1980s, which greatly promoted the development of the pharmaceutical industry and improved the quality level. In the future, the quality management system will strictly follow the international drug quality management standards and technical requirements, strictly revise the quality management norms and add appendices, follow strict certification and follow-up after certification, and adopt a combination of “double random” and flight inspection. Great implementation, truly achieve a comprehensive standard management of pharmaceutical quality.
3 Effective monitoring of adverse drug reactions
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 reports will continue to expand, and the people involved in the report will no longer be limited to regulatory and medical technicians, and more pharmaceutical companies and drug consumers will participate. The review of adverse reaction reports has been rigorous, and the screening rate of effective data has been greatly improved. The application of adverse reaction monitoring results is in-depth, providing timely and accurate information on the control of the market's suspension of sales, recalls and other harmful consequences, and feedback monitoring data to production companies, research institutions and standards revision departments.
4 drug sampling test support is stronger
As the most effective monitoring method for drug quality after listing, the work of drug sampling and testing will continue to increase, and the increase in funding and planned amount will be more suitable for the regulatory requirements of listed drugs. The subdivision support function of the sampling test function is more obvious, and the evaluation function of the national sampling inspection plan will emphasize the whole-area and full-range coverage sampling of the same batch variety. The supervisory function of the local sampling plan will emphasize the specificity of the sampling test, and combine the law enforcement inspection to extract the suspicious varieties on the market as much as possible and conduct personality tests. Non-standard research tests are becoming the norm, mainly for research tests that use standard defects to add illegal alternatives, and more inspection agencies will launch more varieties. The release of the drug quality announcement is more timely, important announcements are released in real time, and general announcements are issued more frequently. The impact of inspection results on regulatory decisions is growing, and testing big data will adjust the focus and direction of regulation.
5 "Internet +" deepening supervision ideas
The application of information technology in drug supervision is more and more extensive, and the degree of intelligence in the development and application of information supervision platform is continuously improved, and more regulatory elements are developed into software installation into the system. With the enhancement of information supervision capabilities, the drug Internet transaction will be further liberalized. It is possible to effectively supervise data communication with enterprise information, collect real-time quality control information of enterprises in accordance with law, and use the system to automatically analyze and compare, make release, warning or take further regulatory measures. Internet push for regulatory information is more, faster, and more real-time, making it easier for the public to understand drug regulation in the first place. The gradual structure of the drug information supervision network covering the whole country has become a reality in the true sense of the whole process control of the varieties and the supervision of the entire chain.
The pattern of social co-governance is gradually forming
6 complaint reporting system into the main platform
In January 2011, the State Food and Drug Administration complained that the Reporting Center was officially in operation. In June 2014, the newly established State Food and Drug Administration re-established the Complaint and Reporting Center, as the direct unit of the State Administration of State, responsible for the acceptance of national drug complaints and reports. Dispose of. The Measures for the Administration of Food and Drug Complaints and Reports (Trial) and the Measures for Reporting Infringements of Food and Drugs have been promulgated, and the contents, procedures and rewards of the reports have been standardized.
Channel construction should be more convenient for complaints reporters to apply, make full use of the Internet to build a platform, so that operation is simple, everywhere, and readily available. The complaint reporting procedure should be more standardized, and the processing should be more timely and accurate. If there is a complaint, it must be received, and if it is reported, it must be checked and checked. The reward system for complaints and reports will be continuously implemented, and the prizes will be awarded.
7 credit system to help drug regulation
With the establishment of a sound social credit system, the compliance of laws and regulations on the production and operation of pharmaceutical companies has increasingly become a measure of the integrity of enterprises. Create a relatively independent and complete pharmaceutical enterprise credit system, improve the integrity evaluation and early warning mechanism marked by the "blacklist" system, and more regard the supervision results as the direct basis for integrity judgment, and further refine the norms. Scientifically divide the level of integrity, and take the lead in applying the integrity of the enterprise to regulatory matters such as drug registration approval, production and operation license certification, and administrative punishment.
8 insurance services will become a powerful force
With the continuous development of the insurance industry, insurance products related to drug safety, such as pharmaceutical business insurance, pharmaceutical product insurance, and drug safety liability insurance, have been continuously introduced, and more and more service to pharmaceutical companies. In the process of formulating pharmaceutical legislation and regulatory policies in the future, the status and role of such services in supervision will be clarified, and mandatory guidance and regulation will be carried out.
9 legal services effectively penetrate
With the acceleration of the rule of law, lawyers' legal services are increasingly entering people's daily lives, infiltrating 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 and effective use of drugs. Lawyers provide legal services in many aspects such as administration, business, and rights protection. On the one hand, they help clients to meet the legal requirements for drug supervision. On the other hand, they seek legal claims for the legality of regulatory actions from the standpoint of relatives. Different directions strongly promote the improvement of the administrative capacity and level of the regulatory authorities according to law.
In addition, the industry self-discipline of the pharmaceutical industry organization and the pharmacist pharmacy service accompanying the drug life cycle will become an indispensable part of the drug co-governing pattern and play an important role.
(Jilin Qijian Biotechnology Co., Ltd._Biopharmaceutical_www.qjbio.com.cn)