Healthcare, including pharmaceuticals, is one of the 12 prioritysectors for ASEAN economic integration, according to a recentannouncement from the ASEAN Secretariat in Jakarta on March 18.
Accordingly,an ASEAN mutual recognition arrangement (MRA) on good manufacturingpractices (GMP) inspection for manufacturers of medicinal products hadbeen deemed a priority initiative.
As stipulated, an agreement onmonitoring the quality of pharmaceutical products will be approved andsigned by the ASEAN member countries, expected in tandem with thecreation of the ASEAN Economic Community (AEC) in 2015.
Under theMRA, all ASEAN countries are obliged to recognise and accept theinspection reports and certificates issued by accepted ASEAN inspectionservices without duplicating GMP inspection in one another’s countries.
Fourapproved ASEAN inspection services include the Singapore HealthSciences Authority, the Malaysia National Pharmaceutical Control Bureau,the Indonesia National Agency for Drug and Food Control; and the Foodand Drug Administration (FDA) of Thailand.
The implementation ofthe ASEAN MRA will benefit the bloc’s members by avoiding duplicated GMPinspections within ASEAN, increasing access to medicinal products forASEAN patients and consumers and increasing the competiveness of ASEAN.
Theimplementation of the ASEAN MRA is expected to contribute to largertargets of the AEC by the end of this year, including developing ASEANinto a highly competitive region with a sole market and production basethat is fully integrated into the global economy.-VNA
Accordingly,an ASEAN mutual recognition arrangement (MRA) on good manufacturingpractices (GMP) inspection for manufacturers of medicinal products hadbeen deemed a priority initiative.
As stipulated, an agreement onmonitoring the quality of pharmaceutical products will be approved andsigned by the ASEAN member countries, expected in tandem with thecreation of the ASEAN Economic Community (AEC) in 2015.
Under theMRA, all ASEAN countries are obliged to recognise and accept theinspection reports and certificates issued by accepted ASEAN inspectionservices without duplicating GMP inspection in one another’s countries.
Fourapproved ASEAN inspection services include the Singapore HealthSciences Authority, the Malaysia National Pharmaceutical Control Bureau,the Indonesia National Agency for Drug and Food Control; and the Foodand Drug Administration (FDA) of Thailand.
The implementation ofthe ASEAN MRA will benefit the bloc’s members by avoiding duplicated GMPinspections within ASEAN, increasing access to medicinal products forASEAN patients and consumers and increasing the competiveness of ASEAN.
Theimplementation of the ASEAN MRA is expected to contribute to largertargets of the AEC by the end of this year, including developing ASEANinto a highly competitive region with a sole market and production basethat is fully integrated into the global economy.-VNA
