China has introduced market exclusivity and data protection mechanisms for the first time under the revised Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China. The revised regulation is set to take effect in May 2026.... Read More
Malaysia’s Medical Device Authority (MDA) has established an Innovative Medical Device Review (IMDR) program to assist developers of novel medical technologies seeking to align with regulatory expectations before formal product registration. The IMDR program is specifically for innovative medical devices, which are generally... Read More
Korea is moving to significantly accelerate patient access to rare disease therapies. This is a result of a sweeping overhaul of its national drug pricing and reimbursement system, approved by the Health Insurance Policy Deliberation Committee. The reform introduces a fast-track pathway that... Read More
China will expand its Unique Device Identifier (UDI) requirements to cover a wider range of medical devices. Under the updated framework that will go into effect on June 1, 2027, all Class II medical devices, including in vitro diagnostic (IVD) reagents, and... Read More
Korea is developing an AI–supported system to assist regulatory drug reviews. The initiative, led by the Ministry of Food and Drug Safety (MFDS), includes a task force to build generative AI tools that can help analyze regulatory submissions, automate repetitive review tasks,... Read More
Japan’s Ministry of Health, Labour and Welfare (MHLW) will expand the eligibility criteria for its “specific-use drug” designation to support the development of drugs addressing significant unmet medical needs. The revised rules, announced on February 27, will take effect on May 1... Read More
In late January, Singapore’s Health Sciences Authority (HSA) published an updated guidance on defect reporting and recall procedures for therapeutic products in Singapore. The new guideline applies to therapeutic products, including biologics, as well as cell, tissue, and gene therapy products. It outlines what... Read More
Japan’s orphan drug designation (ODD) system is designed to promote the development of therapies for rare diseases that affect small patient populations. Because these rare diseases often lack commercially attractive markets, special regulatory and financial incentives are necessary to encourage innovation in... Read More
Background and Legal Framework Japan’s Unique Device Identification (UDI) system was formally established under the 2019 amendment to the Pharmaceutical and Medical Devices Act (PMD Act). The act was amended in 2019 as part of a major reform effort by the Japanese... Read More
On February 6, Japan’s Ministry of Health, Labour and Welfare (MHLW) designated 10 of 86 identified “drug loss” products (innovative products approved in the US and EU that are not available in Japan) as having high medical need. This designation enables the... Read More