In February, Japanese authority MHLW (Ministry of Health, Labour and Welfare) has announced two further changes in pharmaceutical quality regulations.

  1. Packaging inserts in the product package will not be mandatory (abolished), but you must make appropriate product information available through scannable GS-1 code. There has been a long discussion whether to mandate the code as GS-1 or QR, but the decision is now to require GS-1.
  2. The Marketing authorization holder must assign a pharmacist to act as a marketing supervisor-general (somewhat like the EU “Qualified Person”), responsible for quality and safety issues of company products, but in the event that such a pharmacist is not available in the company, the company may have another person serve as a marketing-supervisor-general for up to 5 years. The company, however, is requested to hire a pharmacist and to have a training schedule leading that individual to become the marketing supervisor-general.

These changes become effective from August 1, 2021.