There has been a growing trend of life science manufacturers collaborating with local governments (e.g., at the municipal and prefectural level) in Japan during the past 3-5 years. This trend is observed not only with domestic manufacturers but among foreign…
Public-Private Collaboration Needed to Refine SaMD Regulatory System
To read the full story
Related Article
- Chuikyo Subcommittee OKs Basic SaMD Reimbursement Rule
November 16, 2021
- PMDA’s SaMD Consultation Desk Handling 30 Inquiries per Month
November 16, 2021
- Industry Calls for Simplifying Regulatory Process for SaMD
October 26, 2021
- Japan Drug Makers Prepping to Launch New Organization to Solve Challenges in Digital Health
October 13, 2021
- MHLW Aims to Set Up Evaluation Index, Sakigake System for SaMD by March
June 18, 2021
- MHLW Launches New Office to Fuel SaMD Commercialization
April 6, 2021
- MHLW Formulates Package Strategy for SaMD Commercialization, Eyes Sakigake Scheme
November 26, 2020
COMMENTARY
- Govt Should Examine Challenges with Emergency Approval Scheme Exposed by Shionogi Pill Review
July 25, 2022
- Japan Set to Build Legal Framework for Health Data Use as Initiative Enshrined in Honebuto 2022
July 25, 2022
- Japan Should Accelerate Debate on Legalizing Cannabis-Derived Drugs for Refractory Epilepsies
June 27, 2022
- New Zero Premium Rule Applied to 6 Drugs Since April Rollout, Is It Incentivizing Cost Disclosure?
June 2, 2022
- Foreign Pharma Growing Vocal against Japan’s Pricing Policy, Flags Return of Drug Lag
May 10, 2022
Shionogi’s COVID-19 pill ensitrelvir failed to clear the second round of review by a key advisory panel on July 20. The session drew a great deal of attention since the drug is the first candidate for the application of Japan’s…
The average ratio of females in managerial posts at Japanese drug makers has finally reached a double-digit number, at 10.0%, a Jiho survey found. However, this is still well below a near-25% ratio logged by foreign players operating in the…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…
A total of 15 new drugs (APIs) joined the NHI price list in 2021 with peak sales forecasts topping at 10 billion yen, many of them in the area of orphan diseases and with few mega launches, according to a…