What is the EU pharmaceutical legislation reform?
The EU has been formulating a total redrafting of its pharmaceutical legislation framework since it published its roadmap in March 2021. The general approach was agreed by the council in June 2025. This reform (or “pharma package”) aims to produce two key documents:
- A Regulation to incorporate and supersede current regulations 726/2004 (authorisation and supervision of human/veterinary medicines), 141/2000 (orphan medicinal products) and 1901/2006 (paediatric use)
- A Directive to cover national authorisations, manufacturing/supply, pharmacovigilance, advertising and product information: to repeal directive 2001/83/EC.
More recently, the European Commission has published a list of critical medicines and proposed the Critical Medicines Act, aiming to address supply chain vulnerabilities, market failures and dependencies on single suppliers and third countries. While not part of the original scope, this act can be considered as part of the overall reform.
Why is the EU reframing some of its most core documents?
The pharma package is intended to bring benefits to many different aspects of the industry to benefit both patients and professionals. This includes:
- Providing medicines to a wider audience by creating a single market for medicines, strengthening the supply of medicines by addressing shortages and improving access to affordable medicines;
- Benefitting industry professionals by allowing medicinal products to reach the market sooner by reducing the administrative burden and by promoting innovation, competition and transparency;
- Improving protection for paediatric patients by introducing changes to PIP requirements and exemptions;
- Saving lives and protecting the environment by tackling antimicrobial resistance and improving the environmental sustainability of medicines.
The following sections look more closely at some of these ideas and how the pharma package intends to achieve its goals.
How companies can benefit from the new legislation
As one of the key aims of this reform is to cut costs and slash red tape, pharmaceutical companies can expect a reduced administrative burden to bring their products to the market, allowing for a faster supply of new and established medicines.
Companies that are looking to develop new and innovative medicinal products will be incentivised to engage with this new legislation. Not only are simpler rules and procedures being introduced, but greater patient involvement and rewards of extended Regulatory Data Protection (RDP) for addressing unmet medical needs are intended to increase the competitiveness of the EU market. This will be of benefit to all parties: the EMA, national competent authorities, marketing authorisation holders and patients.
RDP will also be extended by two years if an MA is available in all member states within a certain timeframe. This, alongside other incentives, allows for RDP to stretch to 12 years (up from 11) for non-orphan medicinal products. Further information regarding RDP can be found here.
The multi-step approach to improving access to critical medicines
A critical medicine is one where a missed dose can have serious or even life-threatening consequences for the patient. These include certain products in classes such as antibiotics, anticoagulants, antiepileptics etc, as well as insulin, immunosuppressants, opioid analgesics etc. Recent shortages in the supply of critical medicines have led to the development of a new, coordinated framework to make the supply chain of these vital medicines more resilient.
The pharma package includes both short and long-term solutions for the critical medicine supply problem. The European Voluntary Solidarity Mechanism was launched by the Commission in October 2023, which allows EU member states to flag their requirements for a particular medicine. This is viewed by other member states who can respond to indicate the medicines they have available to redistribute, improving availability where it is most needed. The Union list of Critical Medicines was published in December 2023 to assist in the identification of critical medicines.
In terms of long-term actions, the Commission set up the Critical Medicines Alliance in April 2024, allowing national authorities, industry, civil society representatives, the Commission and EU agencies to address the highest risk gaps in the supply of critical medicines. This alliance promotes coordinated action at an EU level among the constituent parties to reduce the impact of these shortages on healthcare systems and patients.
Recommendations from the alliance formed the basis of the Critical Medicines Act, focussing on modernisation of manufacturing capacity, collaborative procurement and international partnerships for the supply of critical medicines.
Changes to Paediatric Investigation Plan requirements
As part of the pharma package, more detailed criteria for PIPs and waivers are being recommended by the Council. In terms of new requirements:
- PIPs will need to be submitted earlier in the development lifecycle of a medicinal product: now before the start of safety and efficacy studies instead of after the end of pharmacokinetics studies;
- PIPs must be more detailed, specifically to specify any measures to adapt the product’s particulars (e.g. strength, pharmaceutical form) for use in paediatric patients;
- PIP discontinuations must be preceded by a notification and justification to the EMA at least six months in advance;
- PIP waivers may no longer be allowed for products of limited therapeutic benefit and for products that have a mechanism of action that is relevant to children, even if the product in question is only indicated in adults. This is covered in Article 75 of the proposed new Regulation and may be intended to prevent the arbitrary restriction of a new medicinal product’s indications to simply avoid the need for a PIP, where children may otherwise benefit.
The changes being made to PIPs in this reform aren’t all restrictive. Article 74(2) of the new Regulation will allow for “initial” PIPs to be submitted for some products. This exemption from the current process of submitting a completed PIP is intended for medicines with a new mechanism of action and/or medicines to fulfil an unmet medical need in children. This will allow for some PIP requirements to be met later in the development process.
Fighting the impending threat of Anti-Microbial Resistance (AMR)
AMR has been an ever-present threat to humanity for decades now, with the first confirmed cases of MRSA being isolated in the 1960s. AMR is estimated to have been directly responsible for over one million deaths worldwide in 2019, with a further three million cases where it was a contributing factor. Without any action, the death toll is expected to rise, with more medicines becoming ineffective against pathogens that develop immunity over time due to the improper or incomplete use of certain medicines.
It should come as no surprise that the EMA takes this topic very seriously, which is why it features in the pharma package. The Council adopted the Commission’s proposed recommendation in June 2023, “stepping up EU actions to combat AMR to provide solutions for human, animal and environmental health”, addressing:
- The authorisation and surveillance of antimicrobials, including monitoring the consumption of antimicrobials, improved infection prevention/control and a greater emphasis on education for HCPs and the public
- The prudent use of antimicrobials. A target of a 20% reduction in the use of antimicrobials in the EU by 2030 (and the recommendation for additional national targets) aims to slow the progress of AMR by eliminating the use of these medicines where they are not required
- Ensuring the availability of antibiotics to compensate for the reduced sales volumes and returns on investment for medicine developers as a result of the planned reduction in use. This includes incentives such as an extra year of market protection for innovative antimicrobials.
AMR will remain at the centre of the EU’s Global Health Strategy as it recognises that this is a global problem that the EU cannot solve on its own. The reform will help them to push for more global cooperation by addressing AMR in a potential WHO international agreement on pandemic prevention, preparedness and response.
The EU pharmaceutical legislation reform marks the most significant update in decades, aiming to cut red tape, boost innovation and strengthen access to critical medicines.
Key Timeline:
- June 2025: Council adopted its negotiating position; Trilogue negotiations with the European Parliament began.
- Late 2025: Possible political agreement and adoption.
- 2026: Formal publication of the new Regulation and Directive.
- ~ 2027–2028: New rules expected to apply approximately 18–24 months after publication.
- ~ 2029: Full implementation across all Member States, following the Directive’s transposition period into national laws.
The reform’s success will rest on collaboration between regulators, industry and healthcare professionals to ensure Europe delivers safe, effective and affordable treatments for patients.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.
