Overview

• On Sept. 18, an MHLW expert panel endorsed switching tadalafil (Cialis) to nonprescription status, the first ED drug to become OTC in Japan, following an application by SS Pharmaceutical.
• The change still requires a public comment period and the health minister’s approval, and officials note tadalafil already has OTC status in four European countries.
• Sales will fall under the 'required pharmacist-guided medicine' category, with trained staff dispensing face to face only to men 18 or older after counseling and identity checks.
• Once revisions to the pharmaceuticals law take effect as expected next May, online purchases may be permitted after pharmacist explanations.
• Experts say easier access could reduce counterfeit use and help flag patients with possible cardiovascular disease, while medical societies urge quantity limits and checklist-based screening.