Signing of the sectoral mutual recognition agreement (MRA) is viewed by the member states as an important step in the plan to form the ASEAN Economic Community, similar to the European Union single market, by 2015.
The 10 ASEAN member states, which include Singapore, Vietnam and Malaysia, have until January 1 2011 to implement the MRA. Once in place good manufacturing practice (GMP) certificates and inspection reports issued in one of the 10 countries will be used by all member states.
These reports will be used by countries as the basis for granting approval to the manufacturer, supporting post-market assessments and as a source of information about a company’s facilities.
Included in the report will be details of the dosage forms manufactured at a facility and whether it is compliant with GMP. The MRA states that facilities should be “regularly inspected”, although no timeframe is given, and puts measures in place to ensure members have confidence in each others standards.
One aspect of this is that regulatory bodies: “must regularly monitor their respective inspection services to ensure that the latter are capable and remain capable of properly assessing manufacturers.”
This is intended to ensure that standards remain high and other countries have the opportunity to monitor the effectiveness of this through collaborations, such as joint audits or inspections.
By implementing the MRA the ASEAN is hoping to ensure safety, standards and efficacy, reduce the need for repetitive testing and enhance the competitiveness of manufacturers.