Regulatory Guidance updates in July 2026 – ERA have tracked them for you! HPRA (IE): The SoHO Regulation: all you need to know to get started guideline was published by the HPRA Are you involved in activities concerning Substances of Human Origin (SoHO) intended for human applications? Are you a facility where SoHO are applied […]
Regulatory Guidance updates in June 2026 – ERA have tracked them for you! HPRA (IE): HPRA webinar – There was a webinar held on the 19th June 2026 on recent updates and developments in the veterinary medicine regulation A recording should be made available in due course Guidance on “Submitting a Request for a New […]
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ICH M4Q(R2), “The Common Technical Document for the Registration of Pharmaceuticals for Human Use” is a revised draft version of the guidance that outlines how the quality sections of your medicinal product dossier are presented. ICH M4Q(R2) was signed off as a Step 2 document in May 2025. Public consultation closed in October 2025. In […]
Did you know that the following Regulatory Guidance was updated in May 2026? HPRA (IE): Promoting medicines to the public on social media – the HPRA has launched a new webpage, setting out clear information on the laws that apply to advertising human medicines for the public HPRA webinar – There will be a webinar […]
Did you know that the following Regulatory Guidance was updated in March and April 2026? HPRA (IE): HPRA guidance issued in relation to EMA list of ingredients restricted or prohibited for use in cosmetics from 1st May 2026 CTCG Guidance and Webinar: New Article 11 Workaround for Clinical Trials: The Clinical Trials Coordination Group (CTCG) […]
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So what is a Post Approval Change Management Protocol (PACMP) The post approval change management protocol (PACMP) was introduced in the EU through the European Commission Guidelines on variation categories. It is a regulatory tool which allows the management of specific quality change(s) in a more predictable and efficient manner, during the lifecycle of a […]
Let’s get Back to Basics – Biological Medicines According to Part I of Annex I of Directive 2001/83/EC, a biological medicinal product is a product that contains a biological substance. A biological substance is a substance that is produced by or extracted from a biological source and that needs for its characterisation and the determination […]
Here are the main highlights of Regulatory Guidance updated in February 2026 HPRA (IE): The HPRA promoted the Facilitating and Accelerating Strategic Clinical Trials (FAST-EU). FAST-EU is a pilot initiative aiming to accelerate the assessment and authorisation of clinical trials running in multiple EU/EEA countries. The pilot is currently open for submissions and is expected […]
Were you aware that the following Regulatory Guidance was updated in January 2026? HPRA (IE): Updated fee guidance document for Human medicinal products MHRA (UK): The MHRA have been very busy updating their website in January – here are some of the highlights Medicines: International Recognition Procedure Updated dates indicating the submission deadlines for […]
Are you ready to implement the revised variations categories guidance? As of today (15th January 2026) they are to be used for any variation procedure submitted in the EU and UK : EU – New Variations Guidelines in the EC’s Official Journal Regulation (EU) 2024/1701 of 11 March 2024, amending Regulation (EC) No 1234/2008 was […]
The Soroptimist Ireland Girls’ Public Speaking Competition has been running for over 40 years. On 6th November 2025, European Regulatory Affairs Limited (ERA) had the honour of sponsoring, again, the local heat in Dungarvan. The Competition is a three-stage event with local and regional heats leading to a national final. The participants present […]
With growing experience and coverage of the biosimilar market, regulatory strategies must evolve to balance scientific rigor with the need for efficient development. One of the currently most debated topics in the biosimilar arena is the potential waiver for traditional efficacy and safety studies, a move that could significantly reduce development timelines and costs. This […]
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