On 01 April 2019, the Japan Association of Clinical Reagents Industries (JACRI) issued a guideline for marketing information on In-Vitro diagnostics(IVD). The manufacturers, contractors/partner companies (including co-promotion partner companies) need to regulate their marketing information following the guideline.
The regulation came to effect after acts to promote inappropriate use of the drugs in marketing materials surfaced.
Marketing information affected is inclusive of oral explanations, images on a PC, and materials provided electronically.
Marketing material should provide information on the purpose of use, usage, dose (operation method), etc. of the IVD within the approved range. In addition, the company should include safety information without arbitrarily selecting the information; and to provide information based on scientific grounds.
Any false or exaggerated or misleading expressions are prohibited.
When there is a complaint regarding marketing information activities, the management team of the manufacturer should promptly investigate the complaint and take the necessary measures to resolve.
The document also touched on the responsibilities for a person in charge, an in-house system, education, and the responding mechanism to inappropriate marketing information.
This guideline can ensure proper use of the IVDs and improve health and safety through the implementation of the guideline.
More information can be obtained from:- http://www.jacr.or.jp/files/20200401_Jacri2020-001.zip