ASEAN moves a step closer to realization of its vision on integrated health care sector

April 12, 2009 5:21 am 

MANILA, April 11 — The Association of Southeast Asian Nations (ASEAN) has moved a step closer to the realization of its vision of an integrated regional health care sector through the reduction of technical barriers to trade in pharmaceutical products.

On Friday (April 10), the ASEAN economic ministers signed a Sectoral Mutual Recognition Arrangement (MRA) for Good Manufacturing Practice (GMP) Inspection of Manufacturers of Medicinal Products (IRMMP) that would ensure the safety, quality, efficacy and lower prices of drugs being sold in the region.

President Gloria Macapagal-Arroyo is one of the heads of state of the 10-member ASEAN attending the ongoing three-day 14th ASEAN Summit and Related Summits which wind up Sunday (April 12).

In a report, the secretariat of the 14th ASEAN Summit and Related Summits said divergences in national product standards often act as impediments to trade in goods.

"In order to promote deeper economic integration between economies towards the realization of the ASEAN Economic Community by 2015, the harmonization of product standards, and mutual recognition of test report and certification are necessary."

One of the priority sectors of ASEAN, the healthcare program is expected to accelerate the region's economic integration process.

The report on the inspection of manufacturers of medical products seeking good manufacturing practice certifications and/or inspection by authorized agencies will serve as the basis in determining compliance with regulatory requirements.

These include the issuance of licenses to the pharmaceuticals. "The report will also include information on the dosage forms manufactured at the (pharmaceutical) facility and whether the manufacturer complies with the GMP requirements," the report said.

The Sectoral Mutual Recognition Arrangement, which will be fully implemented by all ASEAN member countries by Jan. 1, 2011, requires that "a facility manufacturing medical products shall ensure that it is licensed or authorized to manufacture medicinal products or carry out a manufacturing operation in question."

Pharmaceuticals must also demonstrate proper compliance with the Pharmaceutical Inspection Cooperation Scheme (PIC/S) Guide for Medicinal Products.

The report pointed out that both consumers and manufacturers will benefit from the MRA. "For manufacturers of medicinal products, in particular pharmaceutical products, ensuring the safety, quality and efficacy of their products will become a priority," the report said.

On the part of consumers, the MRA will serve as an assurance that the medicinal products they consume are safe, effective and lives up to the prescribed quality. (PNA) scs/OPS/rsm

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  1. ASEAN moves a step closer to realization of its vision on integrated health care sector | bulantoday.com on April 18th, 2009 3:58 pm

    […] One of the priority sectors of ASEAN, the healthcare program is expected to accelerate the region’s economic integration process. READ FULL STORY. […]