PHARM D
V YEAR NOTES
CLINICAL RESEARCH
2. Clinical development of drug:
METHODS OF POST MARKETING SURVEILLANCE (PMS)
Pharm D notes
Post-Marketing Surveillance (PMS) is a technique for keeping track on a product's safety after it has been given the go-ahead to be marketed, used by the general public, and added additional indications.
Marketing authorization holders (pharmacies and makers of medical devices) perform surveys of healthcare facilities (hospitals and clinics) at the direction of the Ministry of Health, Labour, and Welfare (MHLW) and submit their findings to the MHLW.
Post-marketing surveillance's goal
Post-marketing surveillance is used to verify a product's effectiveness and safety. Additionally, post-marketing surveillance is used to gather usefulness indicators and long-term data due to the limited information that can be obtained prior to the release of new drugs.
The benefits of post-marketing surveillance are as follows.
- By utilizing the vast amount of data that is used in the market, it can increase the safety of a drug or medical device.
- Compared to the clinical study phase, there is a lot more information available.
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