Deal brings single ASEAN pharma market closer
pharmafile | April 22, 2009 | News story | Manufacturing and Production | Asia
An accord signed by economic ministers of the Association of Southeast Asian Nations, aimed at bringing manufacturing standards into line, could be a major step towards the creation of a single ASEAN pharmaceuticals market.
The ministers signed off on a mutual recognition arrangement (MRA) for Good Manufacturing Practice Inspection of Manufacturers of Medicinal Products in Pattaya, Thailand on 10 April, just ahead of the anti-government protests that broke out in the country last week.
The storming of the hotel where the ASEAN summit was being held by hundreds of protestors prompted Thai prime minister Abhisit Vejjajiva to postpone the meeting. It is due to be re-scheduled within the next few days.
The MRA will allow a GMP certifications or an inspection report issued by the competent authority in one ASEAN nation to be recognised by the others and should be in place by 1 January 2011.
The benefits should include reduced business costs for manufacturers since they do not need to subject their products to repetitive testing or certification process. That could mean a single certification or inspection report that could be used as the basis for regulatory approval, support post-marketing assessments of products and register manufacturing or testing facilities.
Consumers will also benefit from knowing that the medicinal products they consume are safe for use, according to the ASEAN Secretariat.
"Divergences in national product standards often act as impediments to trade in goods, " said ASEAN spokesperson Shirley Ramesh.
The next steps will be to implement institutional mechanisms to monitor the implementation of the MRA, Ramesh told Pharmafocus. "Regular reports on the implementation status will be discussed and implementation gaps identified [and] appropriate programmes to address these implementation gaps will be developed. "
Harmonisation of product standards and technical regulations, and mutual recognition of test reports and certification are imperative if ASEAN is to meet its stated objective of setting up a single market by 2015.
ASEAN spans 10 countries, namely Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam.
The group is meeting in Thailand with its partners, Japan, China, India and South Korea. Ramesh noted that at the moment the MRA only applies to the 10 member states and at the moment "no dialogue partner has approached us to participate in such an arrangement ".
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