Discussion on EU medicinal products regulatory expectations and flexibility during COVID-19 public health emergency

ABSTRACT

The current Coronavirus Disease 2019 (COVID-19) public health crisis is posing unprecedented challenges on public health needs of European Union (EU). EU has updated Questions and Answers on Regulatory Expectations for Medicinal Products for human use during the COVID-19 Pandemic in July 2020, adjusted the regulatory expectations and flexibility related to marketing authorization, inspection, pharmacovigilance activities, products information and labelling, etc, during COVID-19 pandemic, articulated series of appropriate measures and provided flexibility legal tools such as exceptional change management process, distant assessment, postponing the testing, prioritisation of pharmacovigilance activities, to help manufacturers and distributors of pharmaceutical products to cope with the consequences of the pandemic, ensure the high standards of quality, safety, efficacy of medicines, and availability of medicinal products. The emergency management experience of EU was still useful for perfecting the drug emergency management system of China.