Japan’s Pharmaceutical Manufacturing Association claims that there are about 150 drugs approved in the US and Europe that are not approved in Japan. Obviously, this is to the detriment of Japan’s healthcare system. Of the drugs not available in Japan yet, about 60%... Read More
Recently, Singapore’s HSA (the Therapeutics Products Branch, Health Products Regulation Group), updated many drug regulations. For new drug applications (NDAs), generic drug applications (GDAs), and major variation applications (MAV-1), companies can expect to receive their first evaluation feedback earlier than before. In addition,... Read More
On July 18, the Japanese Ministry of Health, Labor and Welfare (MHLW) introduced new criteria for excluding certain drugs from mandatory post-marketing surveillance (PMS), traditionally required for newly approved medicines. This initiative aims to mitigate delays and reduce losses in drug availability. The MHLW informed... Read More
The Department of Health (DH) is set to enhance its medical device procurement strategy, building on the first phase implemented on June 21, 2023. The second phase of this strategy will be introduced in two stages to ensure better quality and safety... Read More
In late May, China’s CDE under the NMPA, promulgated a new program for rare diseases called the – Patient-Centered Action for Rare Disease Encouragement (better known as the Care Plan). This pilot program focuses on the “rare disease patient” and is geared... Read More
Japan’s MHLW is again proposing to add to the PMD Act the possibility of using real-world clinical data (RWD) for drug approvals. To date, drug approval in Japan has required randomized controlled Trials (RCT). This program was announced by the House Sciences Council subcommittee... Read More
As China’s strong domestic drug R&D programs lead to many new drugs, there will be increased integration between drug companies and China’s health insurance program. Basically, commercial insurance will help Chinese patients pay for high-priced innovative drugs. By the end of 2023,... Read More
The incidence of cancer is growing globally, especially in India. In 2022, the number of new cancer cases in India was over 1.4 million people – slightly less than the figure in the US. Of course, many cases of cancer are never... Read More
Vietnam’s Ministry of Health presented significant amendments to the pharmaceutical law to the National Assembly in June 2024. The 2016 Pharmaceutical Law, which succeeded the 2005 law, initially provided a transparent legal foundation for the pharmaceutical industry and aligned with global standards.... Read More
As mentioned over the last few years, Japan is trying hard to fix its drug lag problem and provide more drug products, more quickly, to its rapidly aging population. At a June 6 MHLW meeting, two new programs were discussed. The first... Read More