Regulatory expectations for medicinal products in the context of COVID-19

The European Commission (EC), European Medicines Agency (EMA) and the European medicines regulatory network have developed a question-and-answer (Q&A) document for 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 describes areas where regulatory flexibility will help to address some of the constraints marketing authorisation holders (MAH) may be faced with during COVID-19. The measures introduced encapsulate different areas of the regulation of medicines such as marketing authorisations and regulatory procedures, manufacturing and importation of active pharmaceutical ingredients (APIs) and finished products, quality variations, and labelling and packaging requirements with flexibility to facilitate the movement of medicinal products within the EU. Some of the measures described are to be prioritised for crucial medicines for use in COVID-19 patients.

The latest update to the document has added information concerning good manufacturing practice (GMP) and good distribution practice (GDP) certificates, qualified persons (QP) and adverse event reporting.

To ensure the continuing availability of medicines in the EU during the pandemic, in light of safety measures and travel restrictions that prevent on-site inspections, the validity of GMP and GDP certificates, and time-limited manufacturing, import and wholesale authorisations should be extended through 2021.

“The current pandemic is a global public health emergency causing major disruptions that impact citizens, patients and businesses, including the activities of pharmaceutical companies.” Applying the guidelines explained by this Q&A document can help pharmaceutical companies cope with the consequences of the pandemic, while ensuring a high level of quality, safety and efficacy for medicinal products made available to patients in the EU.