FDA listed as inspection service for Asean medicine manufacturing practices
MANILA, Philippines — The Food and Drug Administration (FDA) has officially been included in the list of inspection services under a mutual arrangement between Southeast Asian nations on good manufacturing practices for medicine.
In a statement on Saturday, the Department of Health (DOH) said the FDA was officially listed under the Association of Southeast Asian Nations (Asean) Mutual Recognition Arrangement (MRA) on Good Manufacturing Practices (GMP) for Medicinal Products during the regional bloc’s 28th Consultative Committee on Standards and Quality Pharmaceutical Product Working Group Meeting held in Indonesia last week.
The endorsement, the DOH noted, was agreed upon after the Asean panel of experts assessed the FDA and the “successful establishment of the agency’s technical competence for inclusion in the register of accepted Asean Inspection Services.”
Because of this, FDA-issued GMP certificate for manufacturers of medicinal products as well as FDA GMP inspection reports shall now be accepted by other listed national regulatory agencies under the Asean MRA on GMP, the DOH said.
Health undersecretary and FDA’s officer-in-charge (OIC) director-general, Eric Domingo, said the inclusion of the FDA in the Asean MRA on GMP would be of importance for both the industry and consumers.
He also emphasized that the FDA’s inclusion “is a major step and contribution of the FDA to the government’s strategy to expand economic opportunities in industry and services.”
“For the industry, the inclusion will result in reduced duplication of inspections, cost reduction, facilitation of exports, enhanced market access, enhanced industry reputation, transparency in inspection standards and consistency of inspection,” Domingo said.
“The inclusion will also increase confidence in the quality of medicines for consumers, increase in reliability and quality of medicines, improved consumer safety and protection, better control of counterfeit medicines, and improved access to affordable quality medicines,” he added.
The Philippines is the fifth country to be listed under the Asean MRA on GMP for medicinal products
Singapore’s Health Sciences Authority, Malaysia’s National Pharmaceutical Regulatory Authority, the National Agency of Drug and Food Control of Indonesia and Thailand’s Food and Drug Administration have earlier been listed as inspection services under the arrangement.
