Individually, each of the 10 ASEAN Member States faces strong eco­nomic competition from its Asian neighbors, which have generally larger geographical size and bigger populations — e.g., South Korea: 51 million, Japan: 123 million, and the two Asian giants, India and China, with approximately 1.4 billion population each. Further away in the Western world, there is USA and the European Union (EU) with 340 million and 450 million population respectively. But, col­lectively, ASEAN as a 10-member group is not small. A key strength of ASEAN is its combined population (and, therefore, a potential collective market) of more than 650 million people. ASEAN also has a combined economy of more than 2.5 trillion US dollars, and ASEAN is set to become the 4th largest world economy by 2030. This collective strength of the 10-member ASEAN has been optimized through the creation of an ASEAN Economic Community in 2015.

Sectoral MRA on GMP Inspection unfolded. The co-author remem­bered very clearly that sometime in 2005, there was a long-distance telephone call from his director in Manila — the capital city of the Philippines. His director was then attending an ASEAN senior reg­ulators’ meeting in Manila. “My director spoke to me in his usual composed manner that an ASEAN Taskforce on GMP Inspection was going to be formed, and I was considered the most suitable per­son to lead this Taskforce, and to drive the initiative to develop a pan-ASEAN MRA on GMP inspection. My director asked me point­edly (at that moment in time), if it was okay for me to assume the Chair of a soon-to-be-formed ASEAN MRA Taskforce. As I was mentally unprepared, my knee-jerk response then was to be non-committal, and to request for more time to think through this request. Over the next couple of days, I had to quickly digest this piece of breaking news. Meanwhile, the rationale was explained clearly to me: Singapore’s Health Sciences Authority (HSA) was the 1st Asian member of PIC/S, and the ASEAN pharmaceutical commu­nity was eagerly looking forward to the leadership and experience of Singapore HSA to drive this milestone initiative.” At that 2005 meeting in Manila, Singapore was deemed the most appropriate ASEAN Member State for this driver role. And the rest is history. Singapore was appointed Chair with Malaysia (the 2nd Asian mem­ber of PIC/S) as the Co-Chair of the ASEAN MRA Taskforce on GMP Inspection. “I remained as Chair of this ASEAN MRA Taskforce for seven consecutive years since its inception in 2005 until its dissolu­tion in 2012.” After 2012, a JSC on GMP Inspection was established to implement the provisions of the ASEAN Sectoral MRA, includ­ing the creation of an ASEAN Register of LIS and a training pro­gram for ASEAN pharmaceutical inspectors. “I continued to chair the ASEAN JSC for eight years from 2012 to 2020. All in all, I served

Products at the beach resort of Pattaya in Thailand. The interna­tional PIC/S inspection framework was used as the benchmark for this landmark treaty. With the signing of this MRA, all 10 ASEAN Member States strived towards recognizing one another’s GMP Certificates and inspection reports, and avoided duplicating GMP inspection in each other’s territories. This ASEAN Sectoral MRA comprised 19 Articles, of which Articles 4 and 8 respectively covered the scope and obligations of ASEAN Member States. Under Article 4 on the scope, it is clearly stipulated that the ASEAN Sectoral MRA covers all medicinal products in finished dosage forms, both prescrip­tion medicines and over-the-counter products, as well as sterile and non-sterile medicinal products. It is also clearly stated that the MRA excludes Active Pharmaceutical Ingredients, biologics, clinical trial products and traditional and herbal medicines. Under Article 8 con­cerning the obligations, all 10 ASEAN Member States are obliged to operate a PIC/S-equivalent GMP inspection framework. In addition, all ASEAN Member States are also obliged to accept and recognize GMP Certificates and inspection reports issued by LIS, namely, the inspection services or inspectorates of ASEAN Member States that meet the technical requirements of the PIC/S framework. A grace period of three years from the year of the signing of the MRA (2009)