In the Western world, LinkedIn is a staple for many recruitment professionals. It has proven to be a powerful tool for networking, talent sourcing and job postings. But in Japan, people don’t use LinkedIn very much.Here’s why LinkedIn isn’t popular…
COMMENTARY
With 2nd Strategy Penned, Can Japan Play Catch-Up with US & Europe in SaMD Push?
In early September, Japan released its second package strategy for software as a medical device (SaMD), dubbed “DASH for SaMD 2”. With new measures added to its first edition compiled in 2020, the new strategy embraces “predictability” and “international expansion”…
To read the full story
Related Article
- Regulatory Panel Members Want Clearer Standard for SaMD Efficacy in 2-Stage Approval Scheme
December 27, 2023
- MHLW Notification Outlines 2-Stage Approval Scheme for SaMD
November 21, 2023
- Japan Unveils 2nd Package Strategy for SaMD
September 7, 2023
- MHLW to Unveil Draft of 2nd Package Strategy for SaMD on Sept. 6
August 31, 2023
- SaMD Could Be Eligible for 2-Stage Approval System: MHLW
June 1, 2023
- Japan Deregulation Panel Proposes Two-Step Approval Scheme for SaMD
December 23, 2022
- Public-Private Collaboration Needed to Refine SaMD Regulatory System
November 26, 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
- Japan’s Drug-Loss Landscape Is Transforming Driven by Private Sector
August 21, 2024
- How Will Simplified Delisting, Elective Care Affect G1 Withdrawal Scheme?
August 7, 2024
- Analysis: All Eyes Riveted on FY2024 Drug Price Survey for Off-Year Revision
August 6, 2024
- Lively Debate on Generic Industry Revamp Underway, All Eyes on Consortium Model
July 12, 2024
- Industry’s Ability to Communicate Being Put to Test as Views on Off-Year Price Cuts Change
June 11, 2024
An increasing number of companies in Japan are showing an eagerness to snatch up “drug loss” assets. As of this…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…
A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…
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…