The International Comparative Legal Guide to:Pharmaceutical Advertising 2009

1 General - Medicinal Products
1.1 What laws and codes of practice govern the advertising of
medicinal products in Japan?
In Japan, the “Pharmaceutical Affairs Law” (Law No. 145 of
August 10, 1960, as amended, inter alia, Articles 66-68) and the
“Standards for Fair Advertising Practices concerning Medicinal
Products” (Notice No. 1339 of October 9, 1970, by the Director-
General of the Pharmaceutical Affairs Bureau of the former
Ministry of Welfare) (“Standards for Fair Advertising Practices”)
define universally applicable baseline standards for marketing
practices with respect to medicinal products. As to self-regulation
in the pharmaceutical industry, there are a number of codes of
practice, including but not limited to, the “Code of Practices for
Promotion of Ethical Drugs” (established on March 24, 1993, by
Japan Pharmaceutical Manufactures Association (“JPMA”), as
amended) (the “Code of Practices”) and the “Fair Competition
Rules concerning Restriction on Provision of Unjustifiable
Premium in Manufacture of Ethical Drugs” (enforced on July 1,
1984, by the Fair Trade Council of the Ethical Pharmaceutical
Drugs Manufacturing Industry, as amended) (the “Fair Competition
Rules”). The Fair Competition Rules were established upon
certification by the Japan Fair Trade Commission in accordance
with the “Act against Unjustifiable Premiums and Misleading
Representation”.
1.2 How is “advertising” defined?