The EU Pharma Package - what will, and what will not, change following adoption
the EU Pharma Package has not yet been adopted, but it will be soon. The final European Parliament vote is anticipated for November 2026.
It is unlikely that there will be any fundamental changes in the provisions of either the current draft Directive that will replace Directive 2001/83/EC or, the current draft Regulation that will replace Regulation (EC) No 726/2004 prior to adoption.
While the new provisions will result in substantial changes to the existing rules governing medicinal products in the EU, there are provisions that will remain unchanged.
First ever national HTA relying on an EU JCA results in rejection of product for reimbursement
The national Health Technology Assessment (“HTA”) by the Irish National Centre for Pharmacoeconomics (“NCPE”) of Novartis’ Itvisma was the first HTA in which, according to the NCPE, an EU Joint Clinical Assessment
Phase 2 COMBINE programme launched
Following the success of the first phase of the COMBINE coordinated assessment programme, which permitted the assessment of combined studies through the Clinical Trials Information System (CTIS), the European Commission and EU Member States
Promotion of Medicinal Products on social media
The Irish Health products Regulatory Authority (HPRA) has updated its webpage dedicated to the promotion of medicinal products to the public on social media.
Irish Framework Agreements in principle on supply and pricing of medicinal products
The Irish Minister of Health has announced the conclusion of two Framework Agreements in principle with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) on the pricing and supply of medicinal products. The Agreements, which will apply until 31 December 2029, are intended to strengthen security of supply of medicinal products and reduce the risk of shortages of medicinal products to patients.
The purpose of the Framework Agreement with IPHA is to enhance the current pricing and reimbursement
EMA and FDA set common principles for AI in medicine development
The European Medicines Agency (EMA) and the US FDA have jointly developed ten principles for good Artificial Intelligence (AI) practice in life cycle management for medicinal products.
The purpose of these principles is to permit AI used in the development of medicinal products to be
Updated Guidelines on the Variations Regulation - but not until January 2026
Following adoption of Regulation (EC) No 1234/2008 (the Variations Regulation), which applied from January 2010, the European Commission published related Guidelines in 2013. The Guidelines have not subsequently been updated. As a result, the revisions to the Variations Regulation that occurred in 2021 and 2024 are not reflected in the existing version of the Guidelines.
The new Variation Guidelines that were recently published reflect the 2024 amendment of the Variations Regulation
European Commission sets new clinical trial targets for the EU
The European Commission, the Heads of Medicines Agencies (HMA), and the EMA have jointly developed two new targets for clinical trials, to monitor progress against the ambition of making the EU a more attractive destination for clinical research and to improve timely access to innovative medicines for patients. The aim is that, in the coming five years:
Swissmedic reduces review times for generic medicinal products
Swissmedic has shortening the procedural time limits for applications for new authorisation of generic medicinal products. This change is part of the continuous development of the procedure under Art. 13 TPA
EMA Guideline on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials
The European Medicines Agency (EMA) has introduced a draft new guideline on the inclusion of pregnant and breastfeeding women in clinical trials. The goal is to ensure that developers of clinical trials generate robust clinical data in relation to pregnant and breastfeeding women, so that these individuals and their healthcare providers can make informed, evidence-based decisions when using medicines.
The European Court of Justice clarifies different definitions of a medicinal product and a medical device
In a recent judgment in response to a request for a preliminary ruling (CURIA - List of results) the European Court of Justice (ECJ) provided guidance concerning how to distinguish medicinal products from medical devices.