(People’s Daily Health Client Reporter Wang Aibing) On April 15, the State Food and Drug Administration issued a notice on the “Guiding Principles of Pharmacovigilance Inspection”, pointing out that in order to implement the “Pharmaceutical Administration Law of the People’s Republic of China” and the “People’s Republic of China Vaccine Administration Law” “Regarding the requirements for establishing a pharmacovigilance system, it guides drug regulatory authorities to carry out pharmacovigilance inspections in a scientific and standardized manner, and the State Food and Drug Administration has organized the formulation of the “Guiding Principles of Pharmacovigilance Inspections”.
“The release of the guidelines for pharmacovigilance inspection is a useful attempt. Its implementation is worth looking forward to. It urges and guides enterprises to better carry out pharmacovigilance work. It is not only the obligation of the government supervision department, but also the power of the supervision department, and enterprises must obey and cooperate.” The relevant drug supervision person told reporters that the overall purpose of pharmacovigilance work is to ensure the safety of public medication. .
The person explained, “Pharmacovigilance is one of the tasks in the whole life cycle management of drugs after the market. It is not all, but it is extremely important. All issues related to drug safety are the work of pharmacovigilance. Content, drug safety issues usually include drug quality problems, unreasonable use of drugs, adverse drug reactions, drug shortages, etc., and solving the above problems is the responsibility of pharmacovigilance work. In practice, pharmacovigilance refers to the use of a certain enterprise’s Based on a specific drug variety, around the characteristics of this variety, a series of work is carried out in a purposeful and planned manner. These works are the synthesis of all work related to drug safety. The enterprise is the main responsible person for the pharmacovigilance work, but the enterprise also If we cannot bear all the responsibilities, this requires extensive participation of relevant government departments and social organizations.”
According to the guiding principles, inspections are divided into two categories: routine inspections and inspections for reasons. Routine inspections are routine inspections, which are arranged by the regulatory authorities according to the actual situation. Inspection for a reason refers to inspection for a reason. For example, there are problems in the enterprise, such as late reporting or concealment of suspected adverse drug reaction information; adverse drug reaction monitoring indicates that there may be safety risks, etc. Inspection methods include on-site inspection and remote inspection.
“Years of experience have taught us that Chinese people are still very good at coping with inspections, and some companies are very good at coping with inspections based on standards. This is also a problem we have struggled with when formulating inspection points for many years. No The check points are inconvenient to work, but with the check points, people tend to work around the check points, ignoring the actual work that should be carried out.” The person pointed out that he hoped to avoid this from happening. Everyone can do some real work around the goal of ensuring the safety of public medication.
According to the notice of the “Guiding Principles of Pharmacovigilance Inspection” issued by the State Food and Drug Administration, this “Guiding Principles of Pharmacovigilance Inspection” will be implemented from the date of issuance. The “Notice of the China Food and Drug Administration on Printing and Distributing Adverse Drug Reaction Reports and Monitoring and Inspection Guidelines (Trial)” issued on the 2nd will be abolished at the same time.