US FDA Guidance on Covid-19The US Food and Drug Administration (FDA) has revised its guidance on -marketed adverse event reporting for medical products and dietary supplements during a pandemic to apply the guidance to the COVID-19 pandemic. The previous version from 2012 specifically applied to influenzas pandemic but this has been clarified to apply to all pandemics. The aim of this guidance is to allow companies to focus their limited resources on submitting reports for products used against the pathogen causing the pandemic, as well as other specific reports outlined in the guidance. Firms that are able to continue reporting operations should do so. However, if they are unable to submit adverse event reports to the agency within the required timeframes as a result of pandemic-related employee absenteeism, they must submit all delayed reports within six months of restoring their adverse event reporting process to their pre-pandemic state.
Health Canada Guidance on Covid-19Health Canada has stated that Regulatory reporting of adverse reactions (ARs) and medical device problems (MDPs) should be maintained to the maximum extent possible. However, due to pandemic related employee and personnel shortages, Health Canada accepts if the submission of AR and MDP reports does not occur within the time frames stipulated under various applicable regulations, provided they are submitted as soon as possible. MAHs should maintain records to identify what has been delayed. However, reporting expectations and timelines will be maintained for some high priority products or those used in a pandemic. These include antivirals, vaccines, medicines for outbreak symptom management, medical devices for diagnosis etc.
EMA Guidance on Covid-19On 20 April 2020, the EMA released additional guidance for qualified persons for pharmacovigilance and marketing authorisation holders on submitting COVID-19-related Individual Case Safety Reports (ICSRs) to the EudraVigilance database. This document (linked to in the previous line) provides recommendations relevant to the processing and submission of ICSRs associated with medicinal products used for the treatment or prevention of COVID-19 infection and covers. This guidance reminds organisations of their legal obligations to report suspected adverse drug reactions and highlights applicable guidelines, including the relevant good vigilance practices (GVP) chapters.
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Further Reading from Acorn Regulatorymore than 5600 orphan designated drugs in the biopharmaceutical pipeline. As the sector continues to grow there has been a tendency for facts about orphan drugs to get lost in the midst of issues concerning specific patients’ needs, pricing and availability. We look at some facts about orphan designation that companies considering entering the sector should be aware of. Read more about orphan drugs here. Title V of Directive 2001/83/EC on the ‘Community code relating to medicinal products for human use’ (as amended). Read more about medicinal product labelling here.
- Companies that maintain control of electronic publishing at the corporate and head office level
- Others that have retained the day-to-day eCTD maintenance and lifecycle at a local level
- Companies that have outsourced eCTD entirely