Japan’s Ministry of Health, Labor, and Welfare (MHLW) granted orphan drug designations to 15 drug compounds on February 28, including Novartis Pharma’s atrasentan for IgA nephropathy. Other drugs given this designation include Alexion’s efzimfotase alfa (hypophosphatasia), HanAll Biopharma’s batoclimab (thyroid eye disease),... Read More
According to a recent survey in Japan, based on published documents and press releases as well as discussions with drug companies and the Japan Pharmaceutical Manufacturing Association, 43 novel drugs will be approved and receive NHI pricing in 2025. This will be a... Read More
On December 20, 2024, the Japanese Fiscal Year 2025 NHI drug price revision was implemented. Price revisions in Japan are based on the “discrepancy rates” between the current NHI prices and the actual market prices obtained in the 2024 drug price survey. For... Read More
Over the last year or so, we have reported on the many ways the Japanese government has tried to reduce Japan’s drug loss. So many drugs are approved in the West but not yet available in Japan. Such measures have included a... Read More
In the past, medical device reimbursement in Japan has been a function of – 1. Functional Categories, 2. Foreign Reference Pricing (FRP) and 3. Cost accounting. While functional category and cost accounting are still very important for reimbursement, foreign reference pricing has... Read More
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