Japan has had a flurry of new drug regulations to ease their drug lag problem and make their country more conducive to innovative drugs. As mentioned last month, Japan’s PMDA is now allowing the submission of some innovative drug applications in English and will respond... Read More
In late September, Singapore’s HSA outlined a new eCTD portal program for drugs that will start in early 2025. This is an eCTD portal version 1.0, better than the previous .9 version. This new program will be in a voluntary test phase... Read More
Over the last 20 years, Western medical device makers have had a boom in device exports to Asia. During that time, most Asian countries’ populations have gotten wealthier, seen more government investment in healthcare, seen new, more and advanced healthcare insurance programs... Read More
As mentioned throughout our newsletter last year, Japan is trying to alleviate its drug lag problem and encourage more drug innovation. On a pilot basis, in an announcement in early September, the MHLW has recently noted that they will accept innovative drug... Read More
The Japanese MHLW has increased its budget by over $3 billion for fiscal year 2025. The extra funding will be used to enhance the development of promising drugs and medical devices. Part of the budget will be allocated to building a stronger... Read More
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
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
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
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