The Competent Authorities Response to Covid-19

COVID-19 has transformed almost every aspect of our daily lives. Nevertheless,  patient safety must remain a priorityCOVID-19 may force MAHs and regulatory authorities to operate under business continuity mode, with possible impacts on the standard of workPublic health needs may require quick actions or re-prioritisation of operations. This brief outline updates the guidance issued by some Competent Authorities in response to COVID-19. This document provides general information only and may be subject to change at any time. 

US FDA Guidance on Covid-19

The 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 guidanceFirms 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-19

Health 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-19

 On 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. 

Acorn Regulatory Can Help

If you require assistance, we can assist you.  Our Medical & Pharmacovigilance team has extensive experience in the sector.  Contact us by email: or complete the webform below and we will get back to you. 

Further Reading from Acorn Regulatory

Updated for 2020: Development of the Orphan Drug Sector

Much has been written about orphan drugs in recent times.  These products, developed specifically to treat a rare disease, have become more common in the marketplace.  At the time of writing (May 2020), there are almost 770 orphan drugs commercially available and more 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.

Medicinal Product Labelling: What You Need To Know

Medicinal products are no exception and must be accompanied by outer and/or immediate packaging information (labelling) and a package leaflet providing information enabling the safe and effective use of the medicinal product. In fact, medicinal products are legally required to have certain information on the labels and package leaflets as defined in 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.

Outsourced eCTD Publishing Services: An Overview

More countries are implementing eCTD.  As a result, more companies are being forced to make decisions regarding how they manage their electronic submission and eCTD publishing services.

We typically encounter three scenarios:

  1. Companies that maintain control of electronic publishing at the corporate and head office level
  2. Others that have retained the day-to-day eCTD maintenance and lifecycle at a local level
  3. Companies that have outsourced eCTD entirely

In this article, we will look at the benefits and the limitations presented by the three options presented above.

Find out more about outsourcing eCTD here.