국내외 동향 읽기 페이지
| 제목 | [보고서] [EMA] Report: How EU ensured safety of medicines during COVID-19 230622 |
|---|---|
|
|
| 첨부파일 | |
|
Preparedness for intensified monitoring, methodologies based on established pharmacovigilance tools as well as on innovative approaches and the flexibility and commitment of all the stakeholders involved were key factors to allow the European medicines regulatory network to effectively respond to the pandemic. These activities are detailed in a EMA and EU member states deployed a wide range of measures and tools to proactively collect, analyse and assess the unprecedented volumes of safety data generated during the COVID-19 vaccination campaigns and take the necessary actions. Preparedness started with the design of a comprehensive safety monitoring plan in November 2020, before any COVID-19 vaccine was authorised. National competent authorities and EMA encouraged spontaneous reporting of suspected side effects through dedicated campaigns and communication materials.
Preparedness for intensified monitoring, methodologies based on established pharmacovigilance tools as well as on innovative approaches and the flexibility and commitment of all the stakeholders involved were key factors to allow the European medicines regulatory network to effectively respond to the pandemic. These activities are detailed in a EMA and EU member states deployed a wide range of measures and tools to proactively collect, analyse and assess the unprecedented volumes of safety data generated during the COVID-19 vaccination campaigns and take the necessary actions. Preparedness started with the design of a comprehensive safety monitoring plan in November 2020, before any COVID-19 vaccine was authorised. National competent authorities and EMA encouraged spontaneous reporting of suspected side effects through dedicated campaigns and communication materials.
|
|
| 이전글 ▲ | [한국보건산업진흥원] 2023 글로벌 제약바이오시장 수출지원 보고서(중국) 230721 |
| 다음글 ▼ | [한국보건산업진흥원] 글로벌 제약바이오 산업동향 Vol.03 230726 |
report-pharmacovigilance-tasks-eu-member-states-european-medicines-agency-ema-2019-2022_en.pdf