March 2018: Japan Regulatory Updates

The “Standards for Proper Advertisement of Drugs, etc.” have been established for the purpose that advertisement of drugs, etc. should made properly and should not include false information or exaggerated statement, so that harm caused by drugs, etc. should be prevented in public health. A person intending to advertise drugs, etc. should make efforts to disseminate accurate information so that users may use the drug, etc. properly. The standards include interpretation of the Law about description of names, indications or dosage/administrations, etc. of the drug, etc. as well as matters to be adhered to otherwise misuse or abuse may be encouraged or confidence may be lost among general users(Notification No. 1339 of the PAB dated October 9, 1980). With the recent increased awareness of the public concerning health and the spread of the Internet, there have been cases of advertisement of unapproved drugs by persons acting as importers. Therefore, a notification has been issued concerning guidance and control of individual importers including items related to drug advertising (Notification No. 0828014 of the PMSB dated August 28, 2002).

importer were added. The Law for Partial Amendment of the Pharmaceutical Affairs Law enacted on June 1, 2009 (Law No. 69, June 14, 2006) requires the manufacturer of non-prescription drugs to prescribe in labeling matters specified in the Law in accordance of the level of potential risks. To prevent medical accidents due to misunderstandings, assure traceability, and improve the efficiency in prescription drug distribution, the implementation of barcode labeling for prescription drugs (excluding in vitro diagnostics) (Notification No. 1 of the Economic Affairs Division, HPB and No. 1 of the Safety Division, PFSB both dated June 29, 2012) and preparation of medication guides for patients are being promoted so that the patient understands the prescription drug correctly and serious adverse drug reactions can be discovered at an early stage (Notification No. 0228001 of the Safety Division, PFSB and No. 0228002 of the Compliance and Narcotics Division, PFSB both dated February 28, 2006).

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