Guidelines for the Preparation of Product Information Summaries for Ethical Drugs (Abbreviated name: Preparation Guidelines)
The Japan Pharmaceutical Manufacturers Association (JPMA) has established voluntary standards for product information summaries and advertisements in trade journals (newspapers), which are the main media for communicating ethical drug information to medical professionals, and promotes the proper preparation of materials by member companies.
The voluntary standards are reviewed on a regular basis, and the latest revisions were made to address content that may mislead medical professionals and to ensure more accurate information.
In addition, even if the contents and materials are not clearly stipulated in this guideline, they are required to be prepared in accordance with the Law Concerning Quality, Efficacy and Safety Assurance of Drugs and Medical Devices (Pharmaceutical Affairs Law), as well as the Standards for Proper Advertisement of Pharmaceuticals, Guidelines for Marketing Information Provision Activities for Ethical Drugs, and Pharmaceutical Manufacturers Association Code. The "Law for Ensuring the Effectiveness and Safety of Pharmaceuticals and Related Businesses (Pharmaceutical Marketing Control Law)" is required to be prepared with the understanding of all parties concerned.
We ask for the understanding and cooperation of all parties involved in the application of the code.