ASEAN signs GMP inspection agreement

The Association of Southeast Asian Nations (ASEAN) has signed the ASEAN Sectoral Mutual Recognition Agreement for Good Manufacturing Practice  Inspection of Manufacturers of Medicinal Products, at a summit in  Pattaya, Thailand, shortly before the 14th summit of the regional group  was broken up by local anti-government protesters. The document  highlights the importance of deeper economic integration between the  ASEAN's members with an economic community intended to be realized by  2015.

The Agreement calls for the mutual recognition of GMP certification and  inspection reports by each of the 10 member states' competent  authorities. A statement issued by the ASEAN Secretariat noted that  "these certificates and/or reports will be used as the basis for  regulatory actions such as the granting of approvals or licenses to the  manufacturer, supporting post-market assessments of conformity of these  products and providing information on the manufacturer's facilities  including the testing laboratories, if any, or its contracted  laboratory."

Among the benefits that the regional association hopes to result from  the agreement are: raising the focus of manufacturers on safety and  quality; boosting international recognition of ASEAN members' regulatory  oversight of medicine production; savings to drugmakers by reducing  the duplication of approval procedures from one country to another; and  consumers obtaining the assurance that approved products are safe to  use.