REGULATORY

• In a Flip-Flop, LDP Aims to Enact Clinical Research Bill in Current Diet Session
  April 28, 2016

• Chuikyo Member Prods MHLW to Present Data on Savings through Generic Use
  April 28, 2016

• Govt Achieves 8 Numerical Targets for FY2015 Plan to Promote R&D in Healthcare Field
  April 28, 2016

• Chuikyo OKs 7 Drugs Subject to Cost-Effective Review; Re-Pricing to Be Conducted in 2018
  April 27, 2016

• Japan BCG Faces Business Improvement Order over Manufacturing Methods
  April 27, 2016

• MHLW Panel Supports Ono’s Cancer Drug Carfilzomib
  April 26, 2016

• 13 New Countries Join Japan-EU Mutual Acceptance Scheme for GMP Data
  April 26, 2016

• PMDA Reviewing Risk of Hep B Virus Reactivation for Sovaldi, Harvoni, Other Hep C Drugs
  April 26, 2016

• PMDA Now Has 560 Full-Time Employees in Review Division
  April 25, 2016

• Making PMDA World’s Most Trusted Regulatory Authority through “Regulatory Innovation”: Chief Executive
  April 25, 2016

• Panel Eyes FY2017 Discussion Deadline for Prescribing Rules for Lifestyle Disease Drugs
  April 22, 2016

• Giotrif Label to Add Acute Pancreatitis as Clinically Significant ADR
  April 22, 2016

• Boehringer’s Triple Combo Hypertension Drug Put on Hold by MHLW Advisory Panel
  April 21, 2016

• Key Govt Panel Launches Discussions on New Growth Strategy
  April 20, 2016

• Opdivo’s Fulminant Type 1 Diabetes Risk Re-Stressed in MHLW Safety Bulletin
  April 20, 2016

• LDP Finalizes Proposal for Growth Strategy; Touches on CIN, Drug Discovery Seeds
  April 20, 2016

• Sales Reps Top Source of Drug Safety Information for Both Clinics and Pharmacies: PMDA Survey
  April 19, 2016

• Wholesalers Cited Urgent Deliveries as Major Concern: Ryukaikon
  April 19, 2016

• Wholesalers’ Negative Primary Margins on Sales Level Off: Ryukaikon
  April 18, 2016

• PMDA Had 58 Paid Advisory Sessions on Drug Development for Startups, Academia: FY2015
  April 18, 2016

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