The Irish Health Products Regulatory Authority (HPRA) today announced the introduction of an expedited review process for human health research related to COVID-19.

The Irish Minister for Health also announced the setting up of a dedicated COVID-19 National Research Ethics Committee (NREC-COVID-19).

Applications for clinical trials of human medicines or clinical investigations of medical devices will be given priority and an expedited review by HPRA. The NREC-COVID-19 will review applications concurrently with the regulatory review processes and will endeavour to facilitate an expedited ethical review (see: COVID-19 Related Human Research – Expedited Regulatory and Ethical Review).

This fast-track process is likely to be of interest to the very many global pharma, biotech and device manufacturers already based in Ireland but it will also make Ireland a more favourable jurisdiction in the EU for COVID-19 related human health research.

Photo of Maree Gallagher Maree Gallagher

Maree Gallagher is an Irish qualified solicitor who advises clients on EU food and life sciences law and policy. She has been elected President of the British Irish Chamber of Commerce for 2022/2023.

Maree has over twenty years of experience working with companies…

Maree Gallagher is an Irish qualified solicitor who advises clients on EU food and life sciences law and policy. She has been elected President of the British Irish Chamber of Commerce for 2022/2023.

Maree has over twenty years of experience working with companies to bring their products to market. She is regarded as one of Europe’s leading crisis management experts and has extensive experience advising FMCG companies on product recall and reputation management across the EU.

Maree’s expertise covers drugs and devices with a particular emphasis on biologics and GxP, food and beverages, AGRI, and consumer products. Her practice covers a very wide spectrum from product licensing to composition, labelling, and marketing. Her clients include large public companies as well as multinationals operating in the Life Sciences and FMCG sector across Ireland and the EU. Chambers Global listed Maree as a “Notable Practitioner” in their 2021 Guide to Crisis & Risk Management.

Maree also represents businesses facing regulatory enforcement action and she acts as a strategic and public affairs adviser in her specialist areas.

Photo of Marie Doyle-Rossi Marie Doyle-Rossi

Marie Doyle-Rossi is an Irish and UK qualified lawyer with a Ph.D. in biology. Her practice focuses on life sciences regulatory, commercial and administrative law matters. She has specialized experience in GxP matters and navigating the regulation of complex technologies, including advanced therapeutics…

Marie Doyle-Rossi is an Irish and UK qualified lawyer with a Ph.D. in biology. Her practice focuses on life sciences regulatory, commercial and administrative law matters. She has specialized experience in GxP matters and navigating the regulation of complex technologies, including advanced therapeutics, biologics, combination products, digital health and personalized medicine.

Marie provides strategic, policy and regulatory advice on biologics, orphans, human tissue and cells, market and data exclusivity, clinical trials, pricing and reimbursement, product life-cycle management, data privacy and compliance issues.

She has developed considerable expertise in GxP, including adverse event reporting, quality systems and manufacturing, supply chains and recalls. She regularly counsels clients on “Brexit” related issues from both a UK, EU and Irish perspective.

Marie also advises on, and performs regulatory due diligence for, corporate/commercial transactions including acquisitions, public offerings and clinical trial agreements.

She is associate co-chair of Covington’s Food, Drug, and Device Rapid Response team during the COVID-19 pandemic.