MAP has been provided with an analysis of the EMA COVID-19 Q&A reported on recently.
The European Commission recently published a Q&A document considering the regulatory expectations for medicines during the COVID-19 Pandemic in cooperation with the Coordination group for Mutual recognition and Decentralised procedures – human (CMDh) and the European Medicines Agency (EMA). The document explains some regulatory flexibilities that can be applied to help pharmaceutical companies to handle the consequences of the pandemic, while ensuring a high level of quality, safety and efficacy for medicines made available to patients in the EU. Some of the measures described are reserved for crucial medicines for use in COVID-19 patients. The main measures are:
- Applicants for marketing authorisation for medicinal products intended for use in COVID-19 patients should identify any communication to the relevant NCA with the message “CONCERNS COVID-19” to permit prompt assessment of a request.
- For medicines intended for use in COVID-19 patients Member States can make use of the options such as compassionate use or allow for an unauthorised medicine to be release to the market according with Article 5 (2) Directive 2001/83/EC.
- Manufacturers facing difficulties to meet the foreseen deadline for the renewal of a marketing authorisation due to exceptional circumstances arising from COVID pandemic, can request to postpone the submission of the complete dossier to a later point in time.
- To reduce the risk of shortages or disruption of supply following from manufacturing and/or supply problems, an exceptional change management process (ECMP) is made available to manufacturers of crucial medicines for treatment of COVID- 19 patients. The ECMP will permit the swift implementation of changes to suppliers or manufacturing/control sites (which are not specifically mentioned in the marketing authorisation).
- The quality requirements foreseen in the marketing authorisation should be complied with for medicinal products marketed in the EU, including medicinal products that are administered to COVID-19 patients. MAHs facing difficulties to perform the quality controls due to circumstances related to COVID-19 pandemic should contact the competent authorities and present an adapted control scheme based on a risk-based approach. Applicants should identify their communication with the subject “CONCERNS COVID-19” next to the procedure number in the email heading to permit prompt assessment.
- During the COVID-19 pandemic, Member States may accept that the product information of products marketed in their territory may not be translated into the relevant official language if there are severe problems of availability of that medicinal product. Moreover, it may be accepted that national specific information does not appear in the packaging/labelling, or that the presentation differs from the presentations authorised in Member State where the product is marketed.
 QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC: https://ec.europa.eu/health/sites/health/files/human-use/docs/guidance_regulatory_covid19_en.pdf.
 When in doubt whether a given medicinal product is a crucial medicine for treatment of COVID-19 patients, the MAH may contact the relevant competent authorities.