Committee on Oversight of Pharmaceuticals and Medical Devices Safety Regulation
(1) Background of establishment of the Committee and its roles
The report compiled by the exploratory committee for considering the drug-induced hepatitis cases and preventing recurrence in 2010, recommended the Ministry of Health, Labour and Welfare (MHLW) to establish a third-party body which can monitor and assess the pharmaceutical safety regulation. On the basis of this recommendation, the “Committee on Oversight of Pharmaceuticals and Medical Devices Safety Regulation.” (hereafter referred to as the “COPMeD”) was established in accordance with the revised Act on Pharmaceuticals and Medical Devices (PMD Act) in 2019.
CoPMeD consists of members in various fields, including a medical doctor, pharmacist, jurist and victims of drug-induced sufferings. These members utilize their own specialties to oversight the pharmaceutical safety regulation. This system is expected to secure the safety of pharmaceuticals, etc. and prevent recurrence of drug-induced sufferings.
The report compiled by the exploratory committee for considering the drug-induced hepatitis cases and preventing recurrence in 2010, recommended the Ministry of Health, Labour and Welfare (MHLW) to establish a third-party body which can monitor and assess the pharmaceutical safety regulation. On the basis of this recommendation, the “Committee on Oversight of Pharmaceuticals and Medical Devices Safety Regulation.” (hereafter referred to as the “COPMeD”) was established in accordance with the revised Act on Pharmaceuticals and Medical Devices (PMD Act) in 2019.
CoPMeD consists of members in various fields, including a medical doctor, pharmacist, jurist and victims of drug-induced sufferings. These members utilize their own specialties to oversight the pharmaceutical safety regulation. This system is expected to secure the safety of pharmaceuticals, etc. and prevent recurrence of drug-induced sufferings.
(2) Scope of works of the CoPMeD
CoPMeD monitors and assesses the implementation status of the administrative measures for ensuring safety of pharmaceuticals, etc. and if necessary, gives opinions and recommendations on the measures which should be taken to ensure safety to the Minister of Health, Labour and Welfare. The CoPMeD can also request the heads of relevant administrative organizations to collect information, submit documents and express opinions.
This committee can set an agenda and hold discussions by itself without request from the Minister of Health, Labour and Welfare.
CoPMeD monitors and assesses the implementation status of the administrative measures for ensuring safety of pharmaceuticals, etc. and if necessary, gives opinions and recommendations on the measures which should be taken to ensure safety to the Minister of Health, Labour and Welfare. The CoPMeD can also request the heads of relevant administrative organizations to collect information, submit documents and express opinions.
This committee can set an agenda and hold discussions by itself without request from the Minister of Health, Labour and Welfare.
Stipulations of the PMD Act on CoPMeD (PDF:479KB)
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