REGULATORY
MHLW to Draft Guidelines by Year-End on Use of Patient Registry Data in Drug Filing
The Ministry of Health, Labor and Welfare (MHLW) is drawing up guidelines on patient registry data to enable the use of real world data (RWD) in regulatory applications for drugs, an official has revealed. The ministry intends to present draft…
To read the full story
Related Article
REGULATORY
- LDP Panel Chief Calls for Earlier CGP Coverage in Cancer Care
September 4, 2026
- Japan to Revisit Handling of Steroid Creams under OTC-Like Drug Charge
September 4, 2026
- UK Halts Tavneos for New Patients, Approval Revocation Set for March
September 4, 2026
- Japan Picks 5 COVID Vaccines for NIP Use from October
September 3, 2026
- New MHLW Pharma Chief Puts AI in Regulatory Reviews High on Agenda
September 3, 2026
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…





