Japan has granted regulatory approval for nonprescription versions of the erectile dysfunction treatment Cialis (tadalafil) and the insomnia drug Rozerem (ramelteon) on May 20 — marking the first Rx-to-OTC switch in the respective therapeutic areas. SSP obtained the green light…
To read the full story
Related Article
- SSP to Roll Out Pharmacist Training Ahead of OTC Cialis Launch in Japan
October 1, 2025
- MHLW Panel Endorses Rx-to-OTC Switch of Tadalafil in Japan
September 22, 2025
- SSP Files for OTC Switch of Tadalafil in Japan
June 10, 2025
- MHLW Seeks Comments on Rx-to-OTC Switch of Tadalafil, 2 Other APIs
November 27, 2024
REGULATORY
- MHLW Moves Toward Immunization Act Revision for RSV Antibody Drugs
May 21, 2026
- Japan Approves Nonprescription Cialis, Rozerem
May 21, 2026
- MHLW Panel Clarifies Roles in Vaccine Policy Review Process
May 21, 2026
- Japan to Start CEA Technical Discussions as Early as May 25
May 20, 2026
- LDP Study Group’s Honebuto Proposal Urges “Freeze” on On-Patent Drug Price Cuts
May 20, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





