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Regulation overview

History (highlights)

1992: Proscar approved by U.S. Food and Drug Administration

1997: Propecia approved by FDA

2001: Merck submits Supplementary New Drug Application to FDA with 5-year extension trial data

2008: Sweden adds warning of persistent sexual dysfunction associated with finasteride (1 mg)

2012: US FDA requires a revision to the Propecia label including: “decrease in sex drive that continued after stopping the medication;” “problems with ejaculation that continued after stopping medication;“ and “difficulty in achieving an erection that continued after stopping the medication.”

2021: US FDA requires the addition of hematospermia (blood in semen) to the Postmarketing Experience section of the Propecia label. (Source: FDA letter)


US FDA requires “addition of suicidal ideation and behavior to…the ADVERSE REACTIONS (Postmarketing Experience) section of the Propecia labeling.” (Sources: FDA response (p. 43) • Reuters story)

French regulator ANSM announces the addition of a red box warning to packaging, a new patient information site and patient information sheet.


Health Canada publishes a safety review which found a “possible link between the use of finasteride and the risks of suicidal ideation and self-injury.”

The UK’s Medicines and Healthcare Products Agency (MHRA) will launch a safety review of finasteride (Source: The Daily Mail)

US FDA announces a Patient Listening Session on post-finasteride syndrome.

See also a general timeline and a history of label changes in the U.S.

Regulatory bodies

  • United States: Food and Drug Administration (FDA)
  • Canada: Health Canada
  • Europe: European Medicines Agency (EMA)
  • France: Agence nationale de sécurité du médicament et des produits de santé (ANSM)
  • Sweden: Swedish Medical Products Agency
  • United Kingdom: Medicines and Healthcare products Regulatory Agency (MHRA)
  • Australia: Therapeutic Goods Administration
  • Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
  • Korea: Ministry of Food and Drug Safety (MFDS)


How to access clinical trial data from RIAT Initiative

Posts on regulation