Japan has historically been behind the US and EU when it comes to using DCT for drug research. To date, Japanese clinical trials have been only done at a limited number of hospitals. This means that patients oftentimes need to commute a... Read More
The Singapore Health Sciences Authority (HSA) has broadened its Singapore Health Product Access and Regulatory E-System (SHARE) to cover Class 2 Cell, Tissue, and Gene Therapy Products (CTGTP) as well as dealer licensing and certification applications. Starting February 10, 2025, stakeholders can use SHARE to better... Read More
In early March, the Korean Ministry of Food and Drug Safety (MFDS) announced proposed amendments to the Standards for Medical Device Manufacturing and Quality Management. These amendments aim to speed up the process of granting compliance certification for medical devices. Under this... Read More
The Food and Drug Administration of the Philippines (Philippines FDA) officially declared that for Class A medical devices, the online application process to obtain the Certificate of Medical Device Notification (CMDN) is now the official route. Applicants must submit all CMDN applications through the... Read More
Korea’s Ministry of Health and Welfare announced today that a sweeping reform will change pharmaceutical pricing from March onwards. The reform will be called the “Measures to Improve Drug Pricing Systems to Reward Innovation and Strengthen Health Security”. The goal of the reforms will... Read More
According to the Drug Information Association (DIA), the Chinese pharmaceutical market is still expanding rapidly, as the National Medical Products Administration (NMPA) approved 84 new drugs in 2024, 12% higher than in 2023 and way more than the 50 novel medicines approved... Read More
The Insurance Association of China (IAC) is fast-tracking the proposal for a standardized Commercial Insurance Drug Catalog, which marks a major change in routes of funding for innovative medicines. The IAC, which is an important organization in the self-regulation of the industry, has set... Read More
On March 18, the Japanese MHLW announced six goals to strengthen their clinical trial capabilities. First, Japan wants to build a more advanced, first-class clinical trial regime to enhance and promote local clinical trials. Second, the MHLW hopes to build a better infrastructure... Read More
Starting on January 31, the PMDA will adopt its on-site GCP inspections according to the past performance of facilities that do drug and regenerative medicine clinical trials. At clinical trial facilities where inspections have been carried out very often, certain documentation will... Read More
The Health Ministry of India has initiated an expert panel to monitor and address medical device adverse events to help promote patient safety. The panel will comprise experts from various disciplines of medicine, such as cardiology, neurology, and radiology. These experts will analyze and advise on needed actions to be... Read More