REGULATORY

MHLW Reveals Details of New Withdrawal Rules for Off-Patent Branded Drugs

April 1, 2019

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The Ministry of Health, Labor and Welfare (MHLW) issued a notification on March 29 to provide details on its withdrawal rules for so-called “G1 LLPs (long-listed products),” or off-patent brand name drugs with an 80%-plus generic rate that will face…

To read the full story

It’s Time to Revise G1 Withdrawal Scheme, Rule Likely to Be Applied to Only a Few Products: FPMAJ
June 14, 2022
Pfizer, Bayer to Pull Plug on “G1” Products with High Generic Erosions
March 5, 2021
Several Brand-Name Drug Makers Intend to Withdraw “G1” LLPs
July 4, 2018

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