In May 2018, the EU-funded ARISE Plus programme (Enhanced ASEAN Regional Integration Support from the EU) sponsored a workshop in Jakarta, Indonesia, which ultimately led to the agreement of two new sets of ASEAN Common Technical Requirements (ACTR) for biological products.

The sets of requirements agreed upon during the workshop related to the quality, safety and efficiency of biological products, and were agreed on by the Pharmaceutical Products Working Group (PPWG), of the ASEAN Coordinating Committee on Standards and Quality, which was created in 1999. Since its inception, the PPWG has worked towards harmonising the technical requirements of pharmaceutical products.

These newly agreed sets of technical requirements encompass common conditions for biological products, including vaccines and biotechnology. The inclusion of biotechnology in the PPWG’s activities indicates the first move towards products resulting from biotechnological processes, as opposed to the group’s original centre of attention, which focused on chemical products.

The workshop was attended by 37 participants, among which were representatives from the ASEAN member states, the ASEAN Pharmaceutical Research Industry Association and the ASEAN Pharmaceutical Club. Closing remarks were made by the Chairperson of the Indonesia National Agency of Drug and Food Control, Dr. Ir. Penny K. Lukito, who stated that the workshop’s success was made possible thanks to the conclusive collaboration between officials of the ASEAN Secretariat, the member states and relevant industries. Dr. Ir. Penny K. Lukito further conveyed her gratitude for the EU-funded ARISE Plus project, which sponsored the workshop and has continually provided support to reducing technical barriers within ASEAN.

It is expected that the newly agreed ACTRs, which have been made possible due to agreement on uniform requirements and standards throughout all member states, will help further harmonisation in the pharmaceutical and biological product industry, facilitating trade and ultimately benefiting not only the industry but the population of the region in general.     

AETS has provided technical assistance and ongoing support to the ARISE, and subsequent ARISE Plus, project, since its launch in 2012.