China’s drug regulator is tightening the rules on pharmaceutical traceability. The NMPA has ordered drug marketing authorization holders, local agents, manufacturers, distributors, and end users to fully implement traceability across the supply chain. Every eligible drug product must now carry a unique... Read More
Taiwan’s Food and Drug Administration (TFDA) will streamline documentation requirements for medical device applications starting October 1, 2026. Applicants for Class I, II, and III device registrations may submit color-scanned PDFs electronically rather than mailing physical originals. Companies must retain the original... Read More
Singapore’s Health Sciences Authority (HSA) has spent the past year building a network of bilateral agreements that shorten approval timelines for medical devices and other health products. These agreements cover the UK, Malaysia, China, and Japan, and share a common mechanism: regulators... Read More
Korea operates one of the most tightly managed drug pricing systems in the Asia-Pacific region. Since adopting a “positive list system” in 2006, the country has required every new drug to prove its value before it can be listed on the National... Read More
Rare disease care across Asia is advancing on two fronts: faster regulatory pathways for orphan drugs, and slow-building efforts to fund and diagnose the roughly 258 million people in Asia living with rare conditions. China’s revised Drug Administration Law implementing rules, effective... Read More
China is cracking down on the loosely regulated clinical trials that have enabled its rapid rise as a global biomedical research hub. For years, researchers in China could launch investigator-initiated trials (IITs) largely on their own authority, without approval from China’s NMPA. This flexibility... Read More
On August 5, the Malaysian Ministry of Health (MOH) announced that it is introducing a Hologram Security Label for registered medical devices, building on a system it has used for pharmaceuticals since 2005. A hologram security label is a physical anti-counterfeiting sticker... Read More
Japan’s health ministry will designate a new class of “international hub” hospitals for clinical trials starting in fiscal 2027, aiming to attract more trial business from overseas drugmakers. A subcommittee under the Ministry of Health, Labour and Welfare approved the qualifying criteria... Read More
Korea’s drug regulator is moving on two fronts to speed approvals and cut red tape for the medical sector. On July 31, the Ministry of Food and Drug Safety (MFDS) said that it would streamline the process for converting orphan drugs into... Read More
While many overseas medical device makers are hoping that approval in the “Country of Origin” will no longer be required for medical device registration in China, this regulation has not yet been changed in China. Under the current framework (Order 739), an imported... Read More