(People's Daily health client reporter Wang Aibing)
On April 15, the State Food and Drug Administration issued a notice of the "Guidelines for Pharmacovigilance Inspection", pointing out that in order to implement the requirements of the Drug Administration Law of the People's Republic of China and the Vaccine Administration Law of the People's Republic of China on the establishment of a pharmacovigilance system, and to guide the drug supervision and management departments to scientifically standardize the work of pharmacovigilance inspection, the State Food and Drug Administration organized the formulation of the "Guiding Principles for Pharmacovigilance Inspection".
"The release of the guidelines for pharmacovigilance is a useful attempt, its implementation is worth looking forward to, urging and guiding enterprises to better carry out pharmacovigilance work is not only the obligation of government regulatory departments, it is a must; it is also the power of regulatory authorities, and enterprises must obey and cooperate." Relevant drug regulators told reporters that the overall purpose of carrying out pharmacovigilance work is only one, that is, to ensure the safety of public medication.
The person explained, "Pharmacovigilance is one of the tasks in the post-market life cycle management of drugs, not all of them, but it is extremely important. All problems related to drug safety are the work content of pharmacovigilance, and drug safety issues usually include drug quality problems, improper use of drugs, adverse drug reactions, drug shortage problems, etc. To solve the above problems are the responsibility of pharmacovigilance work. Specific implementation, pharmacovigilance refers to a specific drug variety of an enterprise based on, around the characteristics of this variety, purposeful and planned to carry out a series of work, these work is a combination of all work related to drug safety, the enterprise is the main responsibility of pharmacovigilance work, but the enterprise can not bear all the responsibility, which requires the relevant government departments and social organizations to participate widely. ”
According to the guidelines, inspections are divided into two categories: routine inspections and factorized examinations. Routine inspection is a daily inspection, which is arranged by the regulatory authorities according to the actual situation. A causal examination is a test for a cause. For example, there are problems in the enterprise, such as late reporting and concealment of suspected adverse drug reaction information; adverse drug reaction monitoring prompts that there may be safety risks. Inspection methods include on-site inspection and remote inspection.
"Years of experience tell us that Chinese cope with inspections is still very good, and some companies are very good at responding to inspections according to standards." This is also a problem that we have been struggling with for many years when formulating the main points of inspection. There is no inspection point, the work is inconvenient, but with the inspection points, everyone often does the work around the inspection points, and ignores the work that should actually be carried out. The person pointed out that he hopes to avoid this situation. Everyone can do some real work around the goal of ensuring the safety of public drug use.
In accordance with the notice of the Guiding Principles for Pharmacovigilance Inspection issued by the State Food and Drug Administration, this Guiding Principles for Pharmacovigilance Inspection shall come into force on the date of promulgation, and the Notice of the Former State Food and Drug Administration on Printing and Distributing Adverse Drug Reaction Reports and Monitoring and Inspection Guidelines (Trial) issued by the State Food and Drug Administration on July 2, 2015 shall be abolished at the same time.
