A bill to amend the Pharmaceutical and Medical Devices (PMD) Law is expected to be submitted to the ordinary session of the Diet this year, which was convened on January 17 for a 150-day run. The proposed amendment is for…
REGULATORY
PMDA Reviewing Safety Risk of Imusera/Gilenya
The Pharmaceuticals and Medical Devices Agency (PMDA) is investigating a new side effect risk for the multiple sclerosis (MS) treatment Imusera/Gilenya (fingolimod), a move likely to trigger label changes in the near future. According to the agency’s risk communication update…
To read the full story
Related Article
- Noxafil Contraindicated for Combined Use with Lonasen, Belsomra
December 20, 2021
REGULATORY
- MHLW Council Deems Public Knowledge-Based Filings Acceptable for 8 Fertility Treatment Indications
January 28, 2022
- MHLW Sets Volume Thresholds for Drug Orders to Resolve Generic Shortages
January 28, 2022
- Japan Panel Agrees to Vaccinate Children under Free COVID-19 Inoculation Program
January 27, 2022
- Up to 3 Refills Permitted per Prescription, No Refilling for Drugs with Dosage Restrictions: Chuikyo
January 27, 2022
- Drug Pricing Rules to Be Applied to BMS’ CAR-T Therapy Abecma: Chuikyo
January 27, 2022
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…
Japan’s all-important reimbursement policy panel on December 22 approved an outline of the next drug pricing reform scheduled for April 2022, which embraces plans to reward innovative new indications and introduce a grace period for so-called “spillover” re-pricing.The reform outline…
Remember what it was like back in March, when we all started working from home? There was a distinct change in the air - a sense of freedom and excitement about the novelty of being able to work from home.…
Biogen’s controversial Alzheimer’s drug aducanumab was filed for Japanese regulatory approval in December. If approved, it will be the first…
Japan will go ahead with the introduction of a cost-effectiveness assessment (CEA) scheme for drugs and medical devices in April…