Procedural guidance during COVID-19 pandemic

The COVID-19 pandemic is having a significant impact on European regulatory activity. Many pharmaceutical companies are being directly and indirectly affected by this global situation and had to modify their working procedures and/or regulatory activities to respond to the demands. Likewise, many Health Authorities are carrying out a prioritisation of activities in order to cover the needs that the current situation demands.

The European Commission, the European Medicines Agency and the Heads of Medicines Agencies network (EC, EMA and HMA, respectively) have assessed the situation and agreed on a number of measures to facilitate the management of marketing authorisations for human medicinal products considered crucial during the pandemic period.

The objective of these measures agreed at European level is to promote regulatory flexibility, facilitate, simplify and accelerate the administrative procedures, as far as possible, in order to respond more efficiently to emerging needs during this period.

With this objective the European Commission, in collaboration with the network of Agencies, published questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic:

The CMDh has agreed additional questions and answers that provide practical information on how to specifically address and apply the provisions determined by the European Commission for MR/DC procedures:

All documents will be updated and supplemented with additional information as appropriate. Any changes related to MR/DCP will be reported in the CMDh press release.

European Medicines Regulatory Network COVID-19 Business Continuity Plan

The development and availability of medicines and vaccines for all patients in the European Union, including those with COVID-19, is the number one priority for the European medicines regulatory network. The EU network has published a plan outlining principles for how the network will ensure that core public and animal health regulatory activities, such as the authorisation, maintenance and supervision of human and veterinary medicines will continue to be carried out during the ongoing COVID-19 pandemic.

This includes, in the first instance, procedures related to potential treatments for COVID-19 and vaccines against the virus, those related to medicines needed to treat COVID-19 patients (including crucial medicines used in intensive care units) and procedures to minimise shortages due to COVID-19. The plan also ensures that the EU regulatory system continues to address all other patients’ needs. It therefore sets out how the assessment of non-COVID-19-related medicines will be undertaken during the COVID-19 pandemic, especially when challenges are encountered, for example, with the unavailability of experts due to illness or the need to look after family members.

The plan aims to support the continued functioning of the network as a whole through a consistent approach for all medicines, irrespective of whether they are centrally or nationally authorised.

It includes how Member States could provide back-up for each other, if the disruptions caused by COVID-19 affects their ability to carry out assigned assessments.

Under no circumstances can the assessment of medicines used to treat or prevent COVID-19 be delayed, and Member States must consider their resources and capacity, when putting themselves forward to deal with such an assessment on behalf of the EU.

Delays to the assessment of non-COVID-19-related medicines must also be mitigated as far as possible. Should delays occur for a non-COVID-19 procedure, these will be dealt with according to the details set out in the annexes. Details for medicines subject to the centralised authorisation procedure are outlined in Annex 1 of the document. Arrangements for nationally authorised human medicines are described in Annex 2 and those specific to nationally authorised veterinary medicines are outlined in Annex 3.

More details are provided in the plan. The plan has recently been updated with further information on pharmacovigilance and inspection procedures. It will be reviewed regularly and revised as needed. The EU network will provide further updates and guidance on its implementation as necessary.