Introduction Quality, safety, and efficacy are of the utmost importance for drug products. A vital part in achieving this is having a Drug Master File (DMF). A DMF is a confidential submission to a health authority to provide detailed information about the... Read More
As reported over the last year or so, Japan is trying to fix its drug loss problem, where many drugs approved in the US and EU are still not approved in Japan. Based on past drug approvals in the West, from 2016 to... Read More
On April 3, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) released guidance clarifying its fundamental outlook on determining “competing products” during drug regulatory reviews. The guidance is intended to promote the integrity and fairness of the drug review process given the possibility of conflicts of interest... Read More
In the Asia-Pacific (APAC) region, regulators are taking important steps to shape the future of artificial intelligence (AI) in medical technology. With that progress comes recognition of the usefulness and transformative potential of AI, and the necessity for new levels of oversight.... Read More
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
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
On February 26, the Japanese Health Science Council’s sub-committee on clinical trials set up an FMV pilot program to study clinical trial costs at designated Japanese hospitals. The pilot program will be done in Japan’s fiscal year 2025 which starts in April. This... Read More
Japan’s Ministry of Health, Labour and Welfare (MHLW) is loosening a policy regarding post-approval changes in manufacturing, allowing pharmaceutical companies to submit “annual reports” rather than “minor change notifications” for minor changes with minimal effects on product quality. The relaxation of this rule... Read More
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