The Platform for Research and Inspiration in Regulatory Science held the second expert meeting for complex products on June 28, 2022, inviting experts and scholars from the academia, industry, and regulatory agency to continue the discussion in the first expert meeting on March 9, 2022. Besides the exchange of the opinions on the current domestic and international regulations on the complex drug-lipid platform, complex drug-device combination products (e.g., auto-injectors, metered dose inhalers), and other key areas, experts’ suggestions for the organization of the subsequent international symposium were collected.
Presently, fundamental review standards are implemented for complex products universally, with additional product-specific considerations. The regulations for registration of complex products in Taiwan have general rules in combination with case-by-case considerations depending on specific products. It is suggested that scientific communication should be conducted more often between the industry and the regulatory agency to facilitate the exchange of opinions, development process, and refinement of regulatory requirements.
