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…
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Generic APIs at Crossroads
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Generic APIs at Crossroads - 4: Professor Calls for Monitoring Drugs Liable to Be in Short Supply, Drawing Up Lists of Substitutes
August 17, 2020
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Generic APIs at Crossroads - 3: Gx Society Sets Up Committee for Discussions with Healthcare Providers and API Manufacturers
August 14, 2020
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Generic APIs at Crossroads - 2: Traders’ Group Urges Simpler Regulatory Procedures to Facilitate API Substitution
August 13, 2020
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Generic APIs at Crossroads - 1: Sawai Quality Chief Says Current Biz Structure Hampers Manufacturing Repatriation
July 29, 2020
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…