Like other drug markets, downward price revisions in Japan are common. In an effort to boost drug prices, Japan has a program called the Price Maintenance Plan (PMP). Under the PMP plan, the MHLW allows an additional premium to specific drug prices.... Read More
The MHLW‘s proposed 2024 budget will increase about 12%. Part of this increase will be used to set up a new regulatory consultation group which will focus on expediting pediatric and orphan drugs. This group will also help the MHLW committee in... Read More
According to a recent market research report by Triton Market Research, Asia’s CDX market was valued at $1.4 billion in 2022 and is likely to grow to $3.85 billion by 2030 with a CAGR of 13%. While CDX growth has already accelerated... Read More
Contact us today for a free consultation with a Japan regulatory affairs consultant to discuss your specific needs. When a foreign drug company wants to register its drug in Japan, one of the most important steps is Japan GMP requirements. These GMP... Read More
Contact us today for a free consultation with a Japan regulatory affairs consultant to discuss your specific needs. History and overview Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is responsible for supervising Japan’s medical regulatory procedures, conducting reviews of pharmaceutical and medical... Read More
Please feel free to contact us to obtain more information about Japan DMF. Drug component manufacturers of APIs, excipients, and drug packaging materials who want to protect their intellectual property and manufacturing processes may want to pursue a Japanese Drug Master File... Read More
On July 10, the Japanese MHLW outlined a plan to increase the number of products allowed to apply for Orphan Drug Designation (ODD) and permit this designation earlier in the drug development process. Currently, Japan only accepts orphan drugs that are for... Read More
While much of the Western world has initiated regulations and reimbursement for SaMD products, Japan is still grappling with this product category. The number of SaMD product approvals in Japan dwarfs the number of approvals in the West. As Japan gets more... Read More
Contact us today for a free consultation with a Japan regulatory affairs consultant to discuss your specific needs. One of the key issues in getting drug approval in Japan is to meet Japanese GMP standards. To register a drug in Japan, foreign drug... Read More
On June 16, the PMDA steering committee announced that in April 2024 or shortly thereafter, the PMDA will open offices in the US and Southeast Asia. Likely locations for these offices are Washington DC and Bangkok, Thailand – although this is not... Read More