On the 20th April 2020, the European Medicines Agency (EMA) released their guidance for the requirements involved with the processing and submitting of Individual Case Safety Reports (ICSR) during the COVID-19 pandemic; placing significance on the legal obligation on industry organisations to continue to report suspect adverse reactions, with key considerations concerning legislation Articles 107a of Directive 2001/83/EC and adherence with guidelines set out in GVP Module VI, ICH E2B Guidelines and MedDRA term selections.
In summary of this guidance, with regards to GVP Module VI, the EMA have communicated their recommendations on ICSR reporting principles, including: the correct preparation of ICSRs; active substances and excipients for non-medicinal products; off-label usage; therapeutic efficacy; compassionate use; literature reports and alternative methods for attaining information on potential SARs.
Moreover, regarding the re-release of MedDRA 23.0, the EMA have elaborated on this topic; recommending that industry organisations continue to make use of the free-text additional information fields, when explaining that the MedDRA term being used refers to COVID-19/SARS-CoV-2, until these specified terms become available in May 2020. For more information on the EMA update for the MedDRA 23.0 release, see our previous update here.
However, this has not prevented the EMA from also providing their recommendations for the correct usage of ICH-E2B data elements when reporting reactions that concern COVID-19. Within their recommendations, the EMA provide insight regarding the fields: ‘Reactions/Events’; ‘Indication for Use in Case’; ‘Relevant Medical History and Concurrent Conditions’ and ‘Results of tests and procedures relevant to the investigation of the patient’. Altogether, allowing industry organisations to successfully fulfil their legal obligation and uphold drug safety standards within the current climate.
The EMA has NOT relaxed the licence holders requirement to report Adverse Reactions on time. All licence holders will need to report all adverse reactions in accordance with current regulations and, after the current resolution following COVID-19, there will be an assessment made in audits to ensure Regulatory compliance.
This announcement has mainly been to provide clarification on the content of the reports they receive; together with the announcement that, as a result of COVID-19, the MedDRA dictionary has received a special update to accommodate the COVID-19 symptoms to ensure accurate coding.
PharSafer has provided this update to ensure companies are aware of their legal responsibilities; as well as re-assuring our clients that we have an up to date approach to ensure client compliance and demonstrate our speed in implementing such changes, to keep up to date with global regulatory changes.