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ASEAN Signs MRA for GMP

May 1, 2009

On April 10, 2009, the Association of Southeast Asian Nations (ASEAN) Economic Ministers signed the ASEAN Sectoral Mutual Recognition Arrangement (MRA) for Good Manufacturing Practice (GMP). When implemented, GMP certification and inspection reports received in one ASEAN member nation (in accordance with the MRA) will be accepted in all ASEAN countries without requiring additional testing. The MRA also calls for increased harmonization of standards and reduced non-tariff barriers. ASEAN member nations have until 2011 to fully implement the MRA terms.

Upon implementation of the MRA, GMP certificates and inspection reports that are issued in one country will be available to all other ASEAN countries, eliminating repetitive testing and broadening the market potential for drug manufacturers looking to sell in any of the ASEAN countries. This will also facilitate postmarket surveillance and product registration.

Inspections should be done regularly, and member nations will monitor their inspection services to ensure that different countries' standards stay at the same level and that inspectors are able to adequately assess manufacturing facilities.

The ASEAN nations plan to fully realize their objectives for an ASEAN Economic Community by 2015, similar to the European Union (EU). The ten member nations are Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam.

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