Post-marketing surveillance
Post-marketing surveillance is the ongoing investigation of the safety and efficacy of a drug or medical device after it has been approved and certified for sale and is actually being used by patients. It used to be called post-marketing surveillance.
There are several types of post-marketing surveillance, the main contents of which are as follows
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1.Surveillance of drug use results
This is to investigate the quality, efficacy, and safety of a new drug or medical device over a period of six months to several years after it is placed on the market. The main purposes of a drug use-results survey are to discover and study unknown side effects and to identify factors that may affect safety and efficacy. Among the use-results investigations, those conducted on patients with certain patient conditions, such as children, elderly patients, pregnant patients, and patients with abnormal kidney or liver function, are called specific use-results investigations.
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2.Post-marketing database survey
Medical information databases (electronic medical records, receipts and medical fee statements) are used to confirm safety and usefulness and to detect the occurrence of side effects.
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3.Post-marketing clinical trials
Clinical trial or post-marketing database study to verify the estimates, etc. obtained from the study of the clinical trial, the drug use-results survey or the post-marketing database study. Clinical trials The main purpose of post-marketing clinical trials is to confirm the safety and efficacy of a drug by using clinical trial, drug use-results study or post-marketing database study. The main purpose of post-marketing clinical trials is to verify the safety and efficacy of drugs and medical devices in the medical field. clinical trial The main purpose of post-marketing clinical trials is to discover effects and side effects that were not discovered during the clinical trial phase.
Post-marketing surveillance is conducted primarily by the party responsible for sales (pharmaceutical company, medical device manufacturer, etc.) and involves the collection of patient data with the cooperation of physicians and pharmacists. The information collected is reported to the Ministry of Health, Labour and Welfare, and changes in the usage of drugs and medical devices or additional precautions are made as necessary.
The continuous accumulation of safety information through these surveys and the establishment of more appropriate usage methods are very important for patients to be able to use these products with peace of mind, and is one of the most important mechanisms in place.
- Ministry of Health, Labour and Welfare｜Ministerial Ordinance on Standards for Conducting Post-Marketing Surveillance and Testing of Pharmaceuticals (◆December 20, 2004, Ministry of Health, Labour and Welfare Ordinance No. 171)
- Ministerial Ordinance on Standards for Conducting Post-Marketing Surveillance and Testing of Medical Devices (Ministry of Health, Labour and Welfare Ordinance No. 38 of March 23, 2005)