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ERA logo with TOPRA info, 25 09 25

ERA at TOPRA 2025: Session 6 – Human – How AI is Transforming Regulatory Approaches towards CMC

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 […]

ERA logo with TOPRA info, 25 09 25

ERA at TOPRA 2025: Session 5 – Human – Programme COMBINE – Clinical Trials with Medicine + Medical Device

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) […]

ERA logo with TOPRA info, 25 09 25

ERA at TOPRA 2025: Session 4 – Human – Revision of the EU variation Regulation

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 […]

ERA logo with TOPRA info, 25 09 25

ERA at TOPRA 2025: Session 3 – Human – Applying Artificial Intelligence in Real-Life

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 […]

ERA logo with TOPRA info, 25 09 25

ERA at TOPRA 2025: Session 1 – Human – General Pharmaceutical Legislation – Sandbox

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 […]

ERA jpg v1 25 08 23

It’s our 5th Anniversary!

When European Regulatory Affairs was founded in 2020, it began with a simple mission: Taking your Medicine to the next level. We have grown into a thriving company with a strong presence in the Pharmaceutical Industry. The past five years have been filled with learning, evolution and hard work. ERA has consistently prioritised innovation, customer […]

Training 2

Type IA Annual Reporting in the UK

Following on from our News Article: “You need to apply Type IA Annual Reporting in the EU in 2025” we can further advise that the MHRA has also adopted the EU changes in relation to Type IA variations for UK products.   This means that the MHRA do also require the submission of Annual Updates […]

Help Support Advise Guidance 21 11 19

You need to apply Type IA Annual Reporting in the EU in 2025

The Type IA Annual Update, also known as the “Annual report”, is a single submission of all the Type IA variations (not requiring immediate notification) which have been implemented during the previous twelve months. The Annual report should be submitted as close to 12-month deadline as possible, but ultimately no earlier than 9 months and […]

Windsor Framework, recd 13 02 24

MHRA – Pharmacovigilance – Categories 1 and 2 medicinal products

The Windsor Framework changed the regulation of medicinal products that were formerly in the scope of the EU centralised procedure so that these products are now licensed UK-wide under UK law. Products not within this scope are authorised UK-wide under UK and applicable EU law (as amended by Regulation (EU) 2023/1182 and Directive (EU) 2022/642), […]

Web portal image

EMA recommends use of web-based eAF for NCA submissions (PLM Portal)

The expected start date of the strongly recommended use of the PLM Portal web-based eAF for submissions to the National Competent Authorities for non-Centralised Procedure (CAP) variations is now planned for February 2025.   Please note that the web-based eAF is already fully functional for the submission of variations for CAPs, including EMA-led worksharing variations […]

pharma vigilance

Back to Basics – The Risk Management Plan (RMP)

The Risk Management Plan (RMP) documents the risk management system considered necessary to identify, characterise and minimise a medicinal product’s important risks. The RMP should be updated throughout the life cycle of the product, for example; if there is a change in the list of the safety concerns when there is a significant change in […]

Legal basis

Back to Basics – The Decentralised Procedure (DCP)

We continue our back to basics series for those who may be new to Regulatory Affairs (If you need help with the jargon visit our A-Z Glossary of Regulatory abbreviations). In the EU, there are two different procedures available to apply for a marketing authorisation application (MAA) for the same medicinal product in more than […]

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Need help with all the regulatory jargon?

Check out our updated GLOSSARY OF ABBREVIATIONS AND ACRONYMS.

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