Since the beginning of the COVID-19 pandemic, several adaptations have been necessary to ensure continuity of service for regulatory obligations. Plus the Conditional Approvals of COVID-19 vaccines or off-label use of medicines for disease treatment required increased measures to secure the safety of patients worldwide. In the European Union, EMA issued several guidelines to support the stakeholders through this global challenge. All areas were affected from medicine development to market monitoring to secure transparency ("Transparecy: exceptional measures for COVID-19 medicines"). In Pharmacovigilance these exceptional measures had a major impact on data processing volume, time-to-report safety signals and PRAC recommendations implementation. The increase of information required for Risk Management Plans, and the time to implement new safety guidelines enable the industry to quickly adapt to new challenges with no forewarning. In this context, the monitoring of adverse drug reactions has been reinforced in the specific context of COVID-19. Several specific rules have been implemented, such as new MedDRA coding. The EMA published guidelines on 21 April 2020 relevant to the processing and submission of Individual Case Safety Reports (ICSRs) associated with medicinal products used for the treatment or prevention of COVID-19 infection, taking into account the Notice to stakeholders published by the European Commission and the guidance regarding COVID-19 related terms2 published by the MedDRA MSSO. The purpose of this reinforced monitoring was to ensure, as a priority, the reporting of pharmacovigilance cases, despite the difficulties that healthcare professionals may currently encounter in reporting adverse reactions. If ever, European Commission and EMA specified that they should temporarily - until the pandemic is resolved - prioritise the reporting obligations as follows:
  • Submission of serious ICSRs associated with medicinal products used for the treatment or prevention of the pathogen causing the pandemic;
  • Submission of other serious ICSRs;
  • Submission of non-serious ICSRs associated with medicinal products used for the treatment or prevention of the pathogen causing the pandemic;
  • Submission of other non-serious ICSRs.
It is all the more important as 67% of the adverse events related to COVID-19 were serious adverse events. There was also an increase of off-label use cases due to the use of some products for treatment of COVID-19 in empirical basis which generated a lot of articles relaunching ethical considerations. The WHO specified, in the specific case of bedaquiline and delamanid for the treatment of multidrug-resistant tuberculosis, that even if off-label use is justified when the condition is serious and there is evidence of potential benefit, there is no standard therapy, patients have to be informed and consent (if possible, in written). This increase in activity represents a significant volume of PV data for pharmaceutical companies to process. Organizations need to be put in place to manage this additional activity. This service is one historical asset of PLG portfolio, inside its Medical Information and Vigilance Business Unit, delivered to more than 120 pharmaceutical companies including top ones. ProductLife Group has long ago partnered with clients to build a robust pharmacovigilance outsourcing system not only by being prepared for complex and ever-changing good-pharmacovigilance-practice requirements but also by having the expertise in pharmacovigilance (PV) consulting to respond to commercial needs within the company. Read more about our services in Medical Information and vigilances. Do you want to know more about Covid-19's impact in Regulatory Affairs activities and how regulatory daily operations are vastly changing worldwide? Join us on our PLG Webinar: How Covid-19 Changed The Approach of Health Authorities Worldwide, on June 24th.
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