Japan’s Ministry of Health, Labor, and Welfare (MHLW) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) celebrated the tenth anniversary of their Memorandum of Cooperation with Korea’s Ministry of Food and Drug Safety (MFDS). For the last ten years, the agencies have... Read More
On July 30, 2025, the Singapore Health Sciences Authority (HSA) made some amendments to the regulatory guidance for the registration of therapeutic products. One of the major updates is changes to the submission checklists for New Drug Applications (NDA), Generic Drug Applications... Read More
On July 30, 2025, the Medical Device Authority of Malaysia (MDA) launched the Malaysia–China Medical Device Regulatory Reliance Program (Pilot Phase I) with an end date of September 30, 2025. The program uses the Global Harmonization Working Party (GHWP) structure to form... Read More
While China has dominated the headlines for new drug research and out-licensing to Western pharmaceutical companies, and will continue to do so in the future, Korea, too, is entering the new drug game. While historically Korean drug companies have mainly focused on making... Read More
In July, Vietnam issued Circular 30, which replaced Circular No. 11/2018/TT-BYT and its amendments with respect to drug quality standards. With respect to quality, drugs in Vietnam need to meet the Vietnamese Pharmacopoeia or the US, EU, British, Japanese, or International Pharmacopoeia.... Read More
As China’s medical device sector grows rapidly, it has become a key global manufacturing hub for a wide range of device products, from basic consumables to high-risk implantable devices. This expansion has been accompanied by more stringent regulatory control, with the National... Read More
China Medical Device Regulatory Landscape: A 2025 Update Over the last year, there have been significant changes to China’s medical device regulatory environment as the government tries to strengthen regulatory oversight and improve market access for innovative products. The National Medical Products... Read More
Over the past year, Japan’s regulatory and reimbursement environment for medical devices has been rapidly changing. These changes illustrate the government’s ongoing commitment to healthcare innovation, effective reimbursement mechanisms, and expanded oversight under the updated Pharmaceutical and Medical Device Act (PMD Act).... Read More
Over the past year, India has enacted a series of significant regulatory reforms aimed at boosting the safety, quality, and transparency of its medical device sector. The new regulations and amendments, covering everything from risk-based quality control of imports to enhanced adverse... Read More
In Japan, recruiting patients for clinical trials is not an easy process. Advertising regulations for investigational trials, under Article 68 of the PMD Act, are restrictive and follow the same rules as advertising regulations for already approved drugs. This has made it... Read More