The Japanese Ministry of Health, Labor and Welfare announced important reminders on hazard prevention measures. The announcement sums up what stakeholders should keep in mind based on research and surveys that were conducted by MHLW. It was found that there were several cases where compliance was nearly overlooked.

In this article, we picked up one reminder that is related to foreign manufacturers or companies whose headquarter is in overseas regions.

  • - Facilitation of Smooth Decision-Making between Overseas Manufacturer/Headquarter and Marketing Authorization Holder

The conducted research on safety assurance measures among Marketing Authorization Holders showed that when an overseas manufacturer is related, there is a high tendency that compliance was nearly overlooked.

MHLW alerts that, although MAH is a unified entity who is responsible for safety assurance measures when decision-making is done by an overseas entity, it is important to facilitate a smooth communication system to implement safety assurance measures.

Here are some causes of possible non-compliance that were suggested by the research:

  • A malfunction was found but the report did not reach the responsible department.
  • MAH spent prolonged time obtaining the necessary information to determine the necessity of reporting a malfunction.



MHLW Announced Important Reminders on Hazard Prevention Measures