HPRA

Today marks an important development for sponsors, investigators and other stakeholders – the revision of the ICH Guideline for Good Clinical Practice. ICH E6(R3) (Principles and Annex 1) has become effective in the EU today 23 July 2025. It introduces innovative provisions…

The EMA will host a webinar to introduce the redesigned Sponsor Handbook for the Clinical Trials Information System (CTIS), launching this week. This updated guide will replace all previous materials and become the primary resource for sponsors using the CTIS. 📅 Date:…

This year, the HPRA proudly joined the Dublin Pride Parade for the very first time – and what a day it was!🏳️‍🌈 From colleagues and friends to family members, we marched together to celebrate inclusion, visibility, and community. Our Pride Bake Sale at work was also a success,…

We’re thrilled to announce that the HPRA has won Graduate Programme of the Year at the 2025 Workplace Excellence Awards! This recognition reflects the dedication of our graduates and the incredible teams who support them. Since launching in 2018, our Graduate Programme has…

You can provide feedback on an EMA draft reflection paper about patient access to electronic product information (ePI). The proposal includes using a 2D barcode on medicine packaging, allowing patients and healthcare professionals to access real-time, reliable product…

Our outgoing Chief Executive, Dr Lorraine Nolan, has been appointed as the Executive Director of the @EUDrugsAgency, taking up her new role in January 2026. Congratulations Lorraine from all your colleagues at the HPRA. Earlier this year, the HPRA announced that Dr Nolan would…

Yesterday, we were delighted to be joined again by members of our Patient Forum for our quarterly meeting in the HPRA. Patient representatives and organisations shared their experiences and updates on recent activities, highlighting their continued commitment to advocating for…

Our latest Drug Safety Newsletter offers healthcare professionals essential information on safe and effective use of medicines. It includes information on: → Finasteride and Dutasteride: Outcome of EU review on risk of suicidal ideation → Bilastine (oral): New warning about…

If you own a Zoll Powerheart G5 defibrillator, be aware of a possible issue. If your AED shows Error Code EC 501 during a self-test, this means it will not work in an emergency. Check your device regularly. If you see this error during a self-test, follow the recommended…

This week marked our third annual People Strategy Day — a chance for employees to connect and explore the four pillars of our People Strategy: Purpose, Growth, Belonging, and Wellbeing. We had the privilege of hearing from guest speaker Professor Nicki Panoskaltsis, who shared…

Beware of ads falsely claiming that their products are directly recommended by the HPRA. We do not promote or endorse specific products or specific brands. Don't buy these products, as they may come from untrustworthy suppliers advertising illegally and making false claims.

This year we are hoisting the Progress Pride Flag today, 22 May, to recognise and celebrate the 10-year anniversary of the Marriage Equality vote. We’ll also be walking in the Pride Parade on 28 June for the very first time, as part of our ongoing commitment to fostering a…

You can take part in a European Commission consultation to review the rules that ensure cosmetics meet strict safety requirements before being sold. The Commission is looking for feedback to see how well these rules are working. Anyone interested can provide feedback, including…

You can search for clinical trials happening across the EU with a user-friendly map from the European Medicines Agency – a helpful resource to explore this International #ClinicalTrialsDay. It is available to the public and anyone can search for clinical trials by location or…

Finasteride medicines are used in men to treat hair loss and benign prostate enlargement. The EMA has recently reviewed the safety and effectiveness of these medicines. They remain authorised in the EU. However, suicidal thoughts were confirmed as side effects of finasteride…

Beware of ads falsely claiming that their products are directly recommended by the HPRA. We do not promote or endorse specific products or specific brands. Don't buy these products, as they may come from untrustworthy suppliers advertising illegally and making false claims.

It's #EuropeanImmunisationWeek and no better time to get your child's vaccine schedule back on track. Protect your baby from serious but preventable illnesses like meningitis, measles, and polio. Vaccines are quick, safe and effective. Protect your baby and get them…

HPRA Director of Compliance Grainne Power emphasised the importance of buying prescription medicines only from pharmacies during her interview on @drivetimerte. She highlighted the serious safety and quality concerns associated with medicines bought from unauthorised sources.…