PMDA’s Efforts to Contribute to Ensuring Manufacturing and Quality Control for a Stable Supply of Quality-assured Pharmaceutical Products: Promote Risk Communication Related to the Quality of Pharmaceutical Products

DOI
  • HIRATA Shingo
    独立行政法人 医薬品医療機器総合機構 医薬品品質管理部
  • OKUBO Nobuto
    独立行政法人 医薬品医療機器総合機構 医薬品品質管理部
  • ISHII Ryusei
    独立行政法人 医薬品医療機器総合機構 医薬品品質管理部
  • MIYATA Yu
    厚生労働省 医薬局 監視指導・麻薬対策課
  • HONMA Hitomi
    独立行政法人 医薬品医療機器総合機構 医薬品品質管理部
  • TAKAGI Kazunori
    独立行政法人 医薬品医療機器総合機構 ジェネリック医薬品等審査部
  • MIKAMI Kenichi
    独立行政法人 医薬品医療機器総合機構 医薬品品質管理部

Bibliographic Information

Other Title
  • 品質の確保された医薬品を安定的に供給するための製造管理・品質管理体制の確保に資するPMDAの取り組みについて―医薬品の品質に係るリスクコミュニケーションの促進―

Search this article

Description

<p> Pharmaceuticals and Medical Devices Agency of Japan (PMDA) has been working with the Ministry of Health, Labour and Welfare (MHLW) and prefectural governments to ensure manufacturing and quality control systems, which is the foundation for a stable supply of quality-assured pharmaceutical products, through GMP inspection and other measures. Recently, PMDA has begun a new initiative to promote risk communication related to pharmaceuticals quality, such as facilitating dialogue between industry side and regulatory side and promoting visualization of pharmaceuticals quality, with the aim of further improving manufacturing and quality control at pharmaceuticals manufacturing facilities. We introduce these initiatives included in the 5th Mid-Term Plan of PMDA, which start in 2024 and their future prospects.</p>

Journal

Keywords

Details 詳細情報について

  • CRID
    1390583159491337216
  • DOI
    10.14982/rsmp.14.351
  • ISSN
    21890447
    21857113
  • Text Lang
    ja
  • Data Source
    • JaLC
  • Abstract License Flag
    Disallowed

Report a problem

Back to top