December 14, 2020

Pmda Quality Agreement

Filed under: Uncategorized — Administrator @ 10:48 pm

This is the first update of the original MRA agreement. As part of the product range expansion project, Japan has also assessed and recognised that all relevant EU authorities for the inspection of medicines for human use are equivalent. Some medical devices (especially controlled) for which the Minister of MHLW sets registration requirements. See the link below; www.std.pmda.go.jp/stdDB/index_e.html Japan The core principles of GHTF 1 have been introduced into the Japanese Regulation and all products must comply with the DDAs. The core principles in Japan were revised in 2014, as the GHTF published the revised ghtf document 2. 1:GHTF/SG1/N41R9:2005 2:GHTF/SG1/N68:2012 www.std.pmda.go.jp/stdDB/index_e.html The scope of this agreement has been extended to sterile drugs, certain biologic drugs, including vaccines and immunological drugs, and to the pharmaceutical principles (IPY) of all drugs covered by the agreement. This means that the EU and Japanese authorities have agreed that they have an equivalent regulatory and procedural framework for manufacturer inspections of these products and that they can therefore rely on inspections of the other. PmDA is a Japanese regulator that works closely with MHLW. The PMDA conducts scientific audits on the use of drugs and medical devices for the authorization of drugs and medical devices and on the monitoring of their safety after market. They also provide assistance services for adverse health effects. The PMDA participates in all device approvals and notifications during the product registration process, including various pre-consultations. See the link below; www.pmda.go.jp/english/ The current EU-Japan Mutual Recognition Agreement has been in force since 29 May 2004. It allows regulators to rely on good manufacturing practice (GMP) inspections in the affected areas, not to test batches of medicines entering Japan from EU countries and, conversely, to exchange information on inspections and quality defects.

This agreement allows EU and Japanese regulators to make better use of their inspection resources by reducing dual controls on the territory of the other region. MHLW regulations setting standards for the production and quality control of medical devices. The regulation consists of ISO 13485 provisions and additional requirements specific to Japan. This is a benchmark for any party active in the Japanese medical device industry, including foreign manufacturers exporting devices to the Japanese market.

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