By Dhiraj Behl Amity Institute of Pharmacy, Amity University, India, Janine Jamieson, International Pharmaceutical Quality, Sweden, and Harikesh Kalonia, Amity Institute of Pharmacy, Amity University, India
Innovative, integrated delivery devices are useful for vaccines as well as treatments required for cancer, heart disease, multiple sclerosis and many more serious and chronic diseases. Drug-device combination product types include the classic prefilled syringes and pens, auto-injectors, metered-dose inhalers, dry powder inhalers, and increasingly the inclusion of connected software. However, regulation of these products is complex.
Combination products (CP) such as these are governed by two or more different sets of regulations, based on their components and primary mode of action. This can lead to challenges for regulatory authorities to agree on product review jurisdiction and also how to streamline the drug and device requirements according to philosophy, documentation, and timelines.
Even within a single jurisdiction and regulatory agency things can get difficult. In the US, the Office of Combination Products (OCP) was set up in 2002 and has been active in producing regulations, guidance, training, and participating in external outreach activities. OCP team members participate in conferences to share their learning and their facilitation role for dealing with external queries and internal training, communication and coordination across divisions.
Moreover, around the world, convergence of regulations is handled in different ways and classifications are subject to different interpretations. Due to globalization, diversification of products, and the rising use of digital technologies in healthcare, challenges for both regulators and industry are set to increase.