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Regulatory requirements for medicinal products for human use in the context of the COVID-19 pandemic

  • 2 November 2021
  • active substance, API, certificate, change, coronavirus, COVID-19, ECMP, EudraVigilance, expectations, flexibility, GDP, GMP, ICSR, import, IMs, inspection, MAH, manufacturing, pandemic, pharmacovigilance, PV, QP, QP certification, QPPV, regulation, regulatory, remote, SARS-Cov-2, SMs, variation,
The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients. The document explains some regulatory flexibilities that can
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