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Pharmacovigilance

Monitoring

What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?

The following post-market monitoring mechanisms ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted:

  • Early post-marketing phase vigilance (Article 10 of the Ministerial Ordinance concerning the Standard of Post-Marketing Safety Control for Drugs, Quasi-Drugs, Cosmetics, Medical Devices and Regeneration Medical Products) – the general marketing compliance officer and the safety management supervisor of a marketing approval holder must undertake the early post-marketing phase vigilance for six months following the launch of a new drug (an exemption may be granted on reasonable grounds).
  • Re-examination (Article 14-4 of the Pharmaceutical and Medical Device Act) – a marketing approval holder must submit results regarding the performance of the medicinal product in question every six months for the first two years following authorisation and for one year thereafter (Article 14-4(6) of the act and Article 63(3) of the act’s Ordinance of Enforcement). 
  • Reporting of adverse effects and infection – a marketing approval holder must report any adverse effects of a medicinal product within 15 or 30 days (depending on the object of the report) to the Ministry of Health, Labour and Welfare (Article 68-10 of the Pharmaceutical and Medical Device Act and Article 228-20 of the act’s Ordinance of Enforcement). A marketing approval holder of a biological medicinal product must periodically report any findings of infection to the Ministry of Health, Labour and Welfare (Article 68-24 of the act and Article 241 of the act’s Ordinance of Enforcement). Medical personnel must report any adverse reactions or infections of a medicinal product to the Ministry of Health, Labour and Welfare (Article 68-10(2) of the act).

Re-evaluation (Article 14-6 of the Pharmaceutical and Medical Device Act) – the minister of health, labour and welfare can review the efficacy and safety of an approved drug based on up-to-date medical and pharmaceutical scientific standards.

Data protection

What data protection issues should be considered when conducting pharmacovigilance activities?

When conducting pharmacovigilance activities, due consideration must be given to the handling of personal information under Notification 0812 of the Chief of Pharmaceutical and Food Safety Bureau of the Ministry of Health, Labour and Welfare, dated August 12 2014.

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