Guidance for medicine developers and other stakeholders on COVID-19

The European Medicines Agency (EMA) is providing guidance for medicine developers and pharmaceutical companies to help speed up medicine and vaccine development and approval for COVID-19, and on how they should address the regulatory challenges arising from the COVID-19 pandemic.

Guidance is available for clinical-trial sponsors on how they should adjust the management of clinical trials and participants during the COVID-19 pandemic. This covers concrete changes and protocol deviations for dealing with extraordinary situations, such as the need for isolating participants, limited access to public spaces and the reallocation of healthcare professionals:

• Good clinical practice: Guidance on clinical trial management during the COVID-19 pandemic

Guidance is also available on the actions that sponsors of affected clinical trials should take to help ensure the integrity of their studies and the interpretation of the study results while safeguarding the safety of trial participants as a first priority.

• Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials - Scientific guideline

EMA revised this guidance on 29 June 2020 following a four-week public consultation.

In line with this guidance, EMA will be flexible and pragmatic during the assessment of affected clinical trial data submitted to the Agency as part of marketing authorisation applications.

For inspectors, guidance on how to initiate and conduct good clinical practice inspections remotely during the pandemic is also available:

Guidance is available for companies responsible for human medicines 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:

• Notice to stakeholders: Questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic

The guidance covers:

• marketing authorisation and regulatory procedures;
• the manufacturing and importation of active substances and finished products;
• an exceptional change management process (ECMP);
• quality variations;
• labelling and packaging requirements;
• good manufacturing practice (GMP) and good distribution practice (GDP) certificates and inspections;
• pharmacovigilance inspections, system audits and corrective and preventive actions (CAPAs);
• submitting individual case safety reports (ICSR) to EudraVigilance.

Companies should send ECMP notifications for centrally authorised products to covid-ecmp@ema.europa.eu using this template:

Companies should note that some of the measures described in the guidance are reserved for crucial medicines used for treating COVID-19 patients.

EMA, the European Commission and the European medicines regulatory network agreed this guidance in May 2020.

In July 2022, EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) supported keeping these exceptional measures in place.

Guidance on individual case safety reports

Guidance is available for marketing authorisation holders, sponsors, developers, applicants and national competent authorities on how to submit COVID-19-related individual case safety reports (ICSRs) to EudraVigilance.

This includes how to use COVID-19-related terms from the Medical Dictionary for Regulatory Activities (MedDRA):

EMA updated this guidance in April 2022 to provide further clarification on how to:

• recording patients' vaccine dose schedules in the ICSRs;
• indicate when a vaccine did not appear to work (‘lack of therapeutic efficacy’);
• manage cases where the recipient did not know the name of the vaccine that they received.

Stakeholders mentioned should follow the updated guidance, when submitting new cases and follow-up cases. They do not need to amend ICSRs that they have already submitted to EudraVigilance.

Guidance is available for companies responsible for veterinary medicines on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic:

• Notice to stakeholders: Questions and answers on regulatory expectations for medicinal products for veterinary use during the COVID-19 pandemic

The guidance covers:

• marketing authorisation procedures;
• pharmacovigilance, including pharmacovilance inspections;
• good manufacturing practice (GMP) certificates and inspections;

The guidance was agreed by EMA, the European Commission, the European medicines regulatory network and endorsed by the EU Executive Steering Group on Shortages of Medicines Caused by Major Events.