Pharma Regulatory and Compliance

Key points

Legislative change continues at speed in this area, as the EU’s policy and lawmakers press on with a reform agenda which has continued for a number of years now.
The standout moment in recent months has been the reaching of political agreement on the EU Pharmaceutical Package in December 2025, with this file looking set to be published in the Official Journal by the end of 2026.
Ireland’s Presidency of the Council of the EU will see likely movement on Biotech Act I as well as medical device legislation reform. Agreement has recently been reached on the Critical Medicines Act file.
Ireland saw notable development in early 2026 with agreement reached on a new Framework Agreement on the Supply and Pricing of Medicines 2026-2029 (“FASPM”).

TRADE CONSIDERATIONS

Companies are thinking more strategically about regulatory certainty, supply chain restructuring, investment planning, and long-term market access. Irish pharmaceutical (and medtech) companies are closely monitoring the evolving U.S. tariff environment.

The U.S. Department of Commerce had initiated a national security investigation on 1 April 2025 into imports of pharmaceuticals, active pharmaceutical ingredients, and key starting materials. This was pursuant to section 232 of the US Trade Expansion Act of 1962. The outcome of that investigation has now been published. On 2 April 2026, President Trump issued a Section 232 Proclamation plus 4 Annexes, entitled: “Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients into the United States”, which implements a tiered tariff and incentive-based framework. A Fact Sheet accompanied the Proclamation. This means there is no single fixed rate for pharmaceuticals.

Separately, whilst the Turnberry Agreement reached in July 2025 (which had political agreement on a 15% cap) has just been ratified on the EU side, US tariff activity continues to proceed separately including a recent probe opened into German pricing, leaving the framework operationally uncertain.

European Union

EU PHARMACEUTICAL PACKAGE

The long-awaited revision of the EU pharmaceutical legislation reached a significant milestone when agreement was secured on 11 December 2025 at the trilogue stage between the European Commission, the European Parliament, and the Council of the European Union. This marked the conclusion of interinstitutional negotiations on the comprehensive legislative proposals, which take the form of a new Directive and Regulation, and which are the first major overhaul of EU medicines law in over 20 years.

Agreement was reached at a time when companies are already under pressure to adapt to shifting global trade and supply chain dynamics.

Companies should prepare for fundamental changes to regulatory data protection, market exclusivity, and supply/shortage notification obligations. Strategic planning for product development and lifecycle management will be essential to navigate the new framework effectively. The new texts will enter into force after publication in the Official Journal, which is not expected to take place until later in 2026, as the Directive and Regulation (which together comprise the Package) are indicatively listed for a final plenary in the European Parliament in November 2026.

The Directive has a transposition date of 24 months therefore, full applicability looks to be during 2028.

For more information read our briefings: Movement on the Pharma Package: Formal adoption within reach and EU Pharma Package: Agreement reached

BIOTECH ACT

In a suite of items labelled the “Health Package,” the following were announced on 16 December 2025:

A Biotech Act;

Revised rules for medical devices (see our separate chapter dealing with medical devices);
A “Safe Hearts” plan which takes the form of a Communication on an EU cardiovascular health plan;
The Safe Hearts plan will require work with Member States - one of the aims is to cut premature deaths from cardiovascular disease by 25% by 2035.

The measures comprise a mixture of simplification and new initiatives. For more information read our briefing: Green light – Health Package & Food and Feed Package adopted by European Commission.

Since then, a call for evidence has opened into Biotech Act II, making it clear that this is split into two parts.

Inter-institutional negotiations on the Biotech Act I have not yet kicked off in the fullest sense. The main proposal, which takes the form of a Regulation, remains under a rolling period of consultation, awaiting official translation into all EU languages before it proceeds to formal scrutiny in Parliament and Council, although it is already under review.

The Council has agreed its negotiating position on the Directive aspect of Biotech Act I, which focuses on placing genetically modified micro-organisms and the processing of organs on the market.

Biotech Act I is expected to deliver incremental improvements across the biotech lifecycle. Key areas include:

Simpler, faster processes: Shorter timelines for clinical trials and more coordinated oversight (such as regulatory sandboxes) aim to reduce red tape and accelerate time-to-market for new treatments.

Better support for innovators: Enhanced EU-wide support networks, clearer signposting and targeted funding mechanisms are intended to help biotech ventures develop and scale within the EU instead of relocating abroad.

Maintaining high standards: Streamlining will not dilute EU standards. New biosecurity safeguards and strict data governance requirements (in line with GDPR/EHDS) will ensure innovation progresses alongside robust safety and public health protections.

The Biotech legislative proposals are intended to be a catalyst in the drive for competitiveness in Europe’s life sciences sector, flowing from the recommendations of the Draghi Report. The Act aims to “turn Europe into a biotech powerhouse” with recognition that Europe is not where it needs to be, for example, in terms of venture capital investment and share of clinical trials.

Looking ahead, Ireland’s Programme for the upcoming EU Council Presidency, which commenced on 1 July, has specifically called out the progression of Biotech Act I. We expect much more momentum behind these files, in particular Biotech Act I, to pick up as 2026 progresses. For more, read: Bridging The Gap: An Insight Into Europe's Biotech Proposals.

On the investment side, in a linked initiative, the European Commission and the European Investment Bank (EIB) Group announced an initiative to mobilise €10 billion in investment in 2026-27 into the biotech and life sciences sector, known as “Biotech EU.”

Ireland assumed the Presidency of the Council of the European Union on 1 July 2026.

Ireland

The Irish decision to have a domestic strategy for life sciences was announced in early 2025. In September 2025, the Irish government published an Action Plan for Competitiveness & Productivity which indicated that the national strategy would be published in 2026. The Department of Enterprise, Tourism and Employment held a public consultation on the domestic strategy, which closed in early December 2025, and we understand that work on the strategy is now entering the drafting stage and it should be published by the end of 2026.

New Framework Agreement 2026-2029 published

The FASPM replaces the previous agreement which had been entered into in 2021 and which expired at the end of September 2025 (“the 2021 Agreement”). At the same time, a similar agreement covering the same time period has been published between the State and Medicines for Ireland, the representative body for generic, biosimilar, and value-added medicines.

The FASPM retains the core structure of the 2021 Agreement. However, it does introduce a form of commitment to an 180-day new medicines assessment process, as well as material changes to pricing rules, realignment mechanisms, loss of exclusivity measures, rebates, governance, and security of supply. There are also specific commitments relating to the legislative provisions enshrined in the Health (Pricing and Supply of Medical Goods) Act 2013 (“the 2013 Act”).

For more information read our briefing: Pricing and reimbursement of medicines in Ireland: New Framework Agreement 2026-2029 published

FOCUS ON CLINICAL TRIALS - IRELAND

The NCTOG’s final report, published in November 2025, entitled, “Transforming Ireland’s Clinical Trials Landscape” (the “Report”) outlined six key recommendations.

A Clinical Trials Advisory Council is in the process of being created, to ensure that the recommendations are implemented before the establishment of a National Clinical Trials Body by Q3 2027.

Read our briefing: Clinical trials regulation in Ireland and the EU: Key updates shaping 2025 and 2026.

What's next?

In addition to the developments in train which are set out above, a milestone was reached at the end of April with the completion of the first Joint Clinical Assessment under the Health Technology Assessment Regulation. Notably from an Irish point of view, the co-assessors were Ireland (the NCPE) and Germany. More JCAs will follow, with orphan medicines onstream from 2028 and all centrally authorised medicines from 2030.

On the veterinary products front, new standalone GMP regulations (Regulation (EU) 2025/2091 and Regulation (EU) 2025/2154) apply from 16 July 2026.

The new rules on standards of quality and safety for substances of human origin for use on or in human recipients (SoHo Regulation) has been in force as of July 2024, with most sections to apply from 2027 and some further sections from 2028.

Electronic patient information will also be an area to monitor.

Authors

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