Combination Drug-Device Regulation in Malaysia, South Korea and Australia

Representatives from regulatory authorities of the countries of Malaysia, Australia and South Korea came together in the “International Drug-Device Combinations Session” at DIA Europe 2023 early Thursday. As each described their pathways to approval for combination drug-device products, it became clear that regulation in this area makes sense for each country, but perhaps murky to manage from a global perspective.

In all three countries, the decisions of approval for a drug or a device in a combination situation is determined by the principal mode of action (PMOA). According to Dr. Tony Gill, principal medical adviser in the Therapeutic Goods Administration (TGA) in Australia, and head of the advanced biological and therapies section in the prescription medicines authorization branch of the TGA, the situation of what constitutes a device or a drug in a combination is a complicated scenario of approvals, post-market reporting and involvements of various regulatory sectors, but is predicated on PMOA.

Mariammah Krishnasamy, principal assistant director, head of medical device registration section in the medical device authority for the Ministry of Health, Malaysia, explained here there are two different regulators for the drugs and devices. Again, determining who regulates the combination product is based on the PMOA. In 2018, the two entities came together to propose their guidelines. For both pre-market and post-market needs, the decisions are made between the two agencies on decisions or issues.

In South Korea, Ye-Eun Lee, assistant director, division of novel products approval Ministry of Food and Drug Safety (MFDS) noted that combination products are not classified separately, and when a drug-device product application is submitted to MFDS, the decision is made by the director of novel products, again based on PMOA.

Most countries categorize drug-device combination products as being a single-entity packaged as a drug and device, for example, a pre-filled vaccine syringe and co-packaged combination products.

Session Chair Kathy Wang, regulatory affairs director, devices and digital therapeutics, AstraZeneca (Sweden) followed with audience questions and closed with the following key takeaways: Opportunities for collaboration between countries appear ripe for exploration; that differences exist in philosophies of specific country’s regulators exist on how they approach scientific advice; and the potential to for countries work together to achieve a regulatory framework for combination products.

Reference:

DIA Europe 2023, March 22-24, Basel, Switzerland. “International Drug-Device Combinations Session.”