Regulatory requirements for medicinal products for human use in the context of the COVID-19 pandemic
- 2 November 2021
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The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to 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 explains some regulatory flexibilities that can be applied to 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.
This document provides guidance to marketing authorisation holders of medicinal products for human use (MAH) on regulatory expectations and flexibility during the COVID-19 pandemic.
The measures introduced cover 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;
- an exceptional change management process (ECMP);
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 MAHs of crucial medicines for treatment of COVID-19 patients.
The ECMP, the regulatory tool, will permit the swift implementation of changes to suppliers and/or manufacturing/control sites. Under the ECMP, MAHs will be able to exceptionally source starting materials, reagents, intermediates or active substances from suppliers not specifically mentioned in the marketing authorisation if that is necessary to prevent/mitigate shortages of supplies in the EU. Likewise, MAHs will be able to use manufacturing sites or sites responsible for quality control that are not specifically mentioned in the marketing authorisation in cases where the use of an alternative site is necessary to prevent/mitigate shortages of supplies in the EU.
- quality variations;
- labelling and packaging requirements with flexibility to facilitate the movement of medicinal products within the EU;
- good manufacturing practice (GMP) and good distribution practice (GDP) certificates and inspections;
In the context of restrictions linked to COVID-19 pandemic, for sites in the European Economic Area (EEA), GMP and GDP certificates, and time-limited manufacturing, import and wholesale authorisations are automatically extended until the end of 2022.
For instance, the validity of GMP certificates and time-limited manufacturing and import authorisations, as well as the validity of GDP certificates and time-limited wholesale authorisations will be extended until the end of 2021.
- adaptations that can be applied to the work of the QP in the context of restrictions arising from COVID-19 pandemic (remote batch certification, remote audits of the active substance manufacturer, batch release of investigational medicinal products imported from third countries by relying on a variety of documents);
- pharmacovigilance inspections, system audits and corrective and preventive actions (CAPAs);
- and submitting individual case safety reports (ICSR) to EudraVigilance.
Additional guidance is available here for qualified persons for pharmacovigilance (QPPV) and marketing authorisation holders on submitting COVID-19-related ICSRs to EudraVigilance.
The Notification for MedDRA users regarding existing and new terms for coronavirus concepts is available here.
REMOTE, HYBRID AND ON-SITE AUDITS
Some of the measures described are reserved for crucial medicines for use in COVID-19 patients.
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
(EMA should be contacted for centralised marketing authorisations).
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.
Source: EMA, EC, HMA, ICH