2．Expectations for MIHARI Project from the Perspective of Academia
10.3820/jjpe.20.14
- VernacularTitle:2．医薬品医療機器総合機構における医薬品の安全監視活動への期待：アカデミアから
- Author:
Takuhiro YAMAGUCHI
- Publication Type:Journal Article
- Keywords:
MIHARI Project;
regulatory drug review and approval process;
risk management plan;
collaborative research between regulatory agency and academia
- From:Japanese Journal of Pharmacoepidemiology
2015;20(1):14-16
- CountryJapan
- Language:Japanese
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Abstract:
Based on the history of pharmacovigilance activities in Japan, the expectations for MIHARI Project from the perspective of academia are discussed. First, drug safety and risk-benefit related activities should be enhanced from the early stage of drug development and/or in the regulatory approval stage. Second, more collaboration with regulatory authorities and academia should be promoted. Third, knowledge obtained from MIHARI Project should be published timely and continuously which contribute to related safety activities conducted by other than regulators.
