Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More
This article was originally posted on MedTech Intelligence. Medical Device reimbursement levels in Japan are now more in line with the reimbursement levels in the EU. The Japanese government has pledged not to allow Japanese device reimbursement to be as high as... Read More
As mentioned in our newsletter throughout the last year, Japan is trying to reduce their drug lag – where many innovative Western drugs have still not been registered in Japan. On October 23, one new notification and one revised notification were promulgated. For the... Read More
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