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Compliance and enforcement

Enforcement

What measures are in place to enforce the laws governing medicinal products?

Under the Pharmaceutical and Medical Device Act, the minister of health, labour and welfare and a competent governor of a prefecture may:

  • inspect the offices of manufacturers or sellers of drugs to ensure that they comply with the act or request compliance reports;
  • issue an order to manufacturers or sellers of drugs to take measures to prevent health and hygiene concerns when necessary;
  • issue an order to persons or entities that handle medicinal products to dispose of any drugs that are sold in breach of the act;
  • issue an inspection order to manufacturers of medicinal products by an entity designated by the minister of health, labour and welfare or a governor;
  • issue an order to improve quality control and safety management methods and stop the manufacture and sale of medicinal products if they do not comply with the act; and
  • issue an order to take sufficient measures to prevent the risk of advertising pre-approved drugs.

Dishonest practices

What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?

The Japan Pharmaceutical Manufacturers Association and the Japan Generic Medicine Association have their own voluntary standards regarding dishonest practices. The Fair Competition Code details restrictions on the advertising of medicinal products and the provision of gifts to healthcare professionals. 

Due to a recent trend which emphasises regulatory compliance, pharmaceutical companies and their officers and employees are requested to comply with these standards. Any act by a pharmaceutical company that is contrary to these voluntary standards and appears to be inappropriate for users or consumers can have a negative impact on the company’s business activities and lead to a decline in its performance, even if such an act is not illegal under the applicable law.

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