The Drug Administration recently notified 33 pharmaceutical companies to be named

Recently, Jiangxi Provincial Drug Administration issued a "notice on the implementation of 2020 pharmaceutical preparation production enterprises adverse reactions report and monitoring and inspection work."
notification requirements, pharmaceutical preparation production enterprises in strict accordance with the announcement and the General Administration on the issuance of adverse drug reaction reports and monitoring and inspection guidelines (trial) notice (Food and Drug Administration (2015) No. 78) and other documents, from September 4 to September 16 to carry out a serious self-examination work.
establish and improve the drug adverse reaction monitoring system, set up specialized agencies, staff full-time staff, establish and improve the relevant management system, directly report adverse drug reactions, carry out drug risk benefit assessment, take effective risk control measures.
the relevant information, form a self-examination report, before October 15 will be self-examination report electronic version of the provincial drug adverse reaction monitoring center.
according to the notification requirements, Jiangxi Provincial Drug Administration will organize inspectors to carry out adverse reaction reports and monitoring site special inspection of enterprises in the following list, a total of 33 pharmaceutical enterprises, inspection time in late September.
drug companies must pay attention to the reporting and monitoring of adverse drug reactions, which refers to the process of finding, reporting, evaluating and controlling adverse drug reactions.
the higher the number of reports of adverse drug reactions does not mean a decline in drug safety, but rather means that regulators have more comprehensive information, a better understanding of the risks of drugs, and a greater control of the risks.
almost all drugs can cause adverse reactions, but the degree and rate of reactions vary.
because of the particularity of the drug, pre-market research is very limited and the inherent risks need to be detected through a wide range of clinical applications.
, through strengthening the reporting and monitoring of adverse drug reactions, timely detection of the potential inherent risks of drugs, evaluation of their risk-benefit ratio, and constantly improve drug safety information, to protect the public's drug safety.
The National Drug Adverse Reaction Monitoring Center of the State Drug Administration released the Annual Report on Drug Adverse Reaction Monitoring (2019) on April 10, showing that in 2019 the National Drug Adverse Reaction Monitoring Network received 1.514 million reports of adverse reactions, of which 477,000 were new and serious adverse drug reactions/incidents, accounting for 31.5% of the total number of reports in the same period, a decrease of 1.6 percentage points over 2018.
2019 drug adverse reactions report is still dominated by chemicals, accounting for more than 80% of the total, an increase over the same period in 2018;
according to dosage form statistics, the overall report of injections accounted for more than 60%.
According to the National Drug Adverse Reaction Monitoring Annual Report (2019), 88.1 per cent of reports were reported from medical institutions in 2019, 6.6 per cent from businesses, 5.2 per cent from holders and 0.1 per cent from individuals and other reporters.
that 90% of adverse drug reactions in the United States come from pharmaceutical companies.
companies have specialized agencies and personnel to collect cases of adverse reactions, and take effective action when unexpected harmful reactions to drugs are detected.
According to Article 80 of the newly revised Drug Administration Law, drug market license holders shall carry out post-market adverse reaction monitoring, actively collect and track and analyze information on suspected adverse drug reactions, and take timely risk control measures against drugs that have identified risks.
In addition, the Drug Administration Law clearly stipulates that if the holder should report but does not report adverse reactions, if no post-market risk management plan is formulated, the drug shall be ordered to make corrections within a time limit and given a warning;
that is, pharmaceutical companies that are licensed holders of drugs must assume the main responsibility for monitoring adverse drug reactions.
with the implementation of the newly revised Drug Administration Law, China's pharmaceutical enterprises must pay more and more attention to the monitoring of adverse drug reactions.
Some experts told Seber blue, if domestic pharmaceutical companies can do a good job of monitoring adverse drug reactions, foreign regulatory authorities, the public will think that the drug companies on the quality and safety of drugs attach great importance to, which will also be more conducive to domestic pharmaceutical companies into the European and American markets and other developed countries market, better go international.
can be said that the reporting and monitoring of adverse drug reactions, whether for the enterprise itself or the development of the pharmaceutical industry, have a great role in promoting.
pharmaceutical companies that are leading the way in this work will also see more market opportunities.