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 […]
This session focused on the regulatory implications and readiness strategies for the implementation of electronic Product Information (ePI) based on the HL7 FHIR® standard. As outlined in the EU pharmaceutical strategy and reinforced by EMA’s digital initiatives, the structured, interoperable ePI format will play a critical role in improving the accessibility, reliability, and lifecycle management […]
This session explored the transformative role of Digital tools including Artificial Intelligence (AI) in enhancing Chemistry, Manufacturing, and Controls (CMC) processes within the pharmaceutical industry. As AI technologies continue to advance, their integration into CMC activities offers exciting opportunities to streamline development, optimize manufacturing, and improve regulatory decision-making. Points to note: The Quality Innovation Group […]
This session looked into opportunities and challenges with application procedures when performing a combined clinical trial in Europe, that involves a medicinal product and an in vitro diagnostic (IVD), or companion diagnostic (CDx) and/or a medical device (MD) component. The clinical trial application for the medicinal product is submitted under the Clinical Trial Regulation (CTR) […]
The EU variation Regulation was updated in March 2024 and the new Detailed guideline for classification of variations [last dated from 2008, last update 2013] was published this month. Nevertheless, this is the first step, limited by the current legislation, and a second step is awaited after the new EU general pharmaceutical regulation is in […]
Artificial Intelligence has already been a hot topic in numerous workshops, conferences, symposia and more in the past years. This session focused on questions such as: How is it actually being applied in pharmaceutical development and regulation? Where has it made the most impact in the field? The session put aside the high-level discussions on […]
This session explored key elements of the EU General Pharmaceutical Legislation (GPL) that aim to foster innovation and accelerate patient access to new treatments. Key focus included Platform Technology approaches and Regulatory Sandboxes. By bringing together perspectives from patients, regulators, legislators, academia and industry, the discussion highlighted how these regulatory tools can support cutting-edge pharmaceutical […]
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