Healthcare, including pharmaceuticals, is one of the 12 priority sectors for ASEAN economic integration, according to a recent announcement from the ASEAN Secretariat in Jakarta on March 18.
Accordingly, an ASEAN mutual recognition arrangement (MRA) on good manufacturing practices (GMP) inspection for manufacturers of medicinal products had been deemed a priority initiative.
As stipulated, an agreement on monitoring the quality of pharmaceutical products will be approved and signed by the ASEAN member countries, expected in tandem with the creation of the ASEAN Economic Community (AEC) in 2015.
Under the MRA, all ASEAN countries are obliged to recognise and accept the inspection reports and certificates issued by accepted ASEAN inspection services without duplicating GMP inspection in one another’s countries.
Four approved ASEAN inspection services include the Singapore Health Sciences Authority, the Malaysia National Pharmaceutical Control Bureau, the Indonesia National Agency for Drug and Food Control; and the Food and Drug Administration (FDA) of Thailand.
The implementation of the ASEAN MRA will benefit the bloc’s members by avoiding duplicated GMP inspections within ASEAN, increasing access to medicinal products for ASEAN patients and consumers and increasing the competiveness of ASEAN.
The implementation of the ASEAN MRA is expected to contribute to larger targets of the AEC by the end of this year, including developing ASEAN into a highly competitive region with a sole market and production base that is fully integrated into the global economy.-VNA
Accordingly, an ASEAN mutual recognition arrangement (MRA) on good manufacturing practices (GMP) inspection for manufacturers of medicinal products had been deemed a priority initiative.
As stipulated, an agreement on monitoring the quality of pharmaceutical products will be approved and signed by the ASEAN member countries, expected in tandem with the creation of the ASEAN Economic Community (AEC) in 2015.
Under the MRA, all ASEAN countries are obliged to recognise and accept the inspection reports and certificates issued by accepted ASEAN inspection services without duplicating GMP inspection in one another’s countries.
Four approved ASEAN inspection services include the Singapore Health Sciences Authority, the Malaysia National Pharmaceutical Control Bureau, the Indonesia National Agency for Drug and Food Control; and the Food and Drug Administration (FDA) of Thailand.
The implementation of the ASEAN MRA will benefit the bloc’s members by avoiding duplicated GMP inspections within ASEAN, increasing access to medicinal products for ASEAN patients and consumers and increasing the competiveness of ASEAN.
The implementation of the ASEAN MRA is expected to contribute to larger targets of the AEC by the end of this year, including developing ASEAN into a highly competitive region with a sole market and production base that is fully integrated into the global economy.-VNA
