1. Overview In Hong Kong, the oversight of medical devices falls under the jurisdiction of the Medical Device Control Office (MDCO). It is tasked with regulating and ensuring compliance with standards for medical devices within the territory. Similarly, the Department of Health... Read More
1. Overview The Philippines Food and Drug Administration operates as a regulatory body within the Filipino government’s Department of Health. Its primary responsibility is to ensure the safety, efficacy, and quality of various health products including, drugs, medical devices, food, cosmetics, biologicals,... Read More
As reported over the last 6 months, Japan’s MHLW is initiating plans to reduce its drug lag and drug loss problems. Accordingly, the MHLW has increased its budget to expedite drug approvals in 2024 and strengthened its price maintenance plan. In addition,... Read More
Real World Data can bolster medical device registration applications in China, even though it cannot be utilized as the only clinical evidence source for product registrations. Recently, the NMPA presented a document to gather public feedback on – the Guidelines for Registration... Read More
Korea has been at the forefront of the development of healthcare AI and digital products. Accordingly, the Korean MFDS tried to incorporate regulation changes to accommodate these new and innovative technologies. Today, in Korea’s National Assembly, three important regulatory reforms are being... Read More
Meeting Japanese drug GMP requirements is a key factor for drug registration in Japan. In the past, pharmaceutical inspections were done by prefectural governments at generic and other drug factories, and the PMDA did inspections at factories with high-risk drug products, like... Read More
A few months ago, a number of Chinese organizations including the Ministry of Public Safety, the Ministry of Industry and Information and Technology, the Ministry of Science and Technology, and the Cyberspace Administration outlined interim measures on the field of AI. These... Read More
As mentioned in our July Pacific Bridge Newsletter, Korea plans to increase drug reimbursement for innovative, cancer and rare disease drugs. This reimbursement increase has been confirmed in the recently released Seoul National University R&DB Research Foundation report. In addition to better... Read More
In late October, the Singapore HSA requested that relevant players provide feedback on their draft Guidance for Device Clinical Evaluation. Before medical device registration in Singapore, a medical device must show clinical evidence aligning with the appropriate – Essential Principles of Safety... Read More
Taiwan is Asia’s 6th largest drug market with many Western drug companies selling their products there. However, similar to many other drug markets around the world, Taiwan wants to reduce drug prices and government health expenditures. Accordingly, in mid-September, Taiwan’s National Health... Read More