Abstract
Regenerative medical products are of increasing interest for repair or replacement of damaged or destroyed tissues, making the path for more patients with incurable diseases to be treated effectively. Expediting the development and facilitating the access to regenerative medicine, it is important to keep the balance between efficient provision of innovative therapies and appropriate steps to ensure safety and efficacy. While many countries have various regulatory frameworks for clinical trials and medical treatments, the Act on the Safety of Regenerative Medicine and the Revised Pharmaceutical Affairs Law (PMD Act, i.e., the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative Medical Products, Quasi-Drugs and Cosmetics) have been put into effect simultaneously in Japan since November 2014. The PMD Act defines “regenerative medical products” (including gene therapeutics and cellular products) discretely from pharmaceuticals and medical devices, enabling to give conditional and time-limited marketing authorization to those products. The Pharmaceutical Affairs Consultation on R&D Strategy at PMDA makes both sponsors and regulators to secure scientific sound discussion in order to accelerate the development of regenerative medical products with timely provision of safety and effectiveness.
