Unpacking the EU Pharma Package

On 6 March 2026, the European Union published the long-awaited texts of its landmark pharmaceutical regulatory reforms.

The EU legislature recognises the need to reform and modernise the regulatory framework in response to an increasingly challenging external environment, including rapid scientific and technological advances, globalisation of supply chains, heightened environmental concerns, and persistent issues related to public health and patient access to affordable medicines. The legislative changes, set out in both a Regulation and a Directive, aim to ensure fair access to safe, effective, and affordable medicines across the EU, enhance the competitiveness of the pharmaceutical industry by reducing regulatory burdens, and strengthen security of supply to prevent and manage shortages.

This Alert examines a select number of reforms that will reshape the EU pharmaceutical sector in the years ahead.

Data and market exclusivities

• Data protection period. The standard data protection period for innovative medicinal products will remain eight years from the date of marketing authorisation (MA). Provided certain conditions are met, when applying for an MA for a priority anti-microbial, applicants can request a transferable data exclusivity voucher which, if granted, gives the holder the right to an additional 12 months of data exclusivity for one authorised medicinal product.
• Market exclusivity period. The standard period of market protection following the data protection period is reduced from two to one year. This period can be extended by 12 months under certain circumstances, for example, if the medicinal product addresses an unmet medical need, contains a new active substance, or the EU MA was the first product approval sought by the applicant, amongst others.

Orphan medicinal products

• Orphan market exclusivity. The standard market exclusivity period for orphan medicinal products will become nine years. “Breakthrough” orphan medicinal products (i.e. those treating conditions for which there is no existing treatment, and treatment with the medicinal product results in a clinically relevant reduction in disease morbidity or mortality), will be awarded 11 years of market exclusivity. Both periods can be extended by 12 months if, at least two years before expiry, the MA holder (MAH) obtains approval for a new therapeutic indication for a different orphan condition. The new operational framework eliminates the possibility for a single medicinal product to obtain multiple separate periods of orphan market exclusivity for different orphan indications.
• Similar orphan products. Orphan applications for similar products or new therapeutic indications can be assessed during the final two years of market exclusivity, but authorisation will only take effect after the exclusivity expires.

Changes to MA applications and processes

• Streamlined assessment timelines. Instead of 210 days, the European Medicines Agency (EMA) will have 180 days to issue an opinion on centralised MA applications (MAA), or 150 days for medicinal products of “major interest” to public health. The recitals of both instruments demonstrate the intention for the Commission to make a binding decision on the MA within 46 days, replacing the current operational timeframe of 67 days.
• Decentralised manufacturing. Decentralised manufacturing brings production closer to patients. It is particularly suited to personalised medicines, short shelf-life therapies, complex biological medicines, and modular medicines, where localised manufacturing improves supply and access. Decentralised sites must be under the control and supervision of a central site. The request for authorisation to conduct decentralised manufacturing must be submitted as part of the MAA and must be accompanied by certain documents including written confirmation that the Qualified Person has verified the decentralised site’s compliance with the principles of good manufacturing practice.
• Environmental risk assessments. All MAAs must include an environmental risk assessment (ERA). The ERA must indicate if the medicinal product, or any of its ingredients or constituents are persistent, bioaccumulative, mobile, toxic, or endocrine active agents. ERAs for anti-microbials and medicinal products containing or consisting of genetically modified organisms require additional risk assessment.

Paediatric indications

• Market launch obligations. Following completion of a paediatric investigation plan, if a product is approved for a paediatric indication, the MAH must within two years place the medicinal product on the market with the paediatric indication in all relevant Member States.
• Discontinuation. MAHs must provide 12 months’ notice to the relevant competent authorities before withdrawing a medicinal product authorised for a paediatric indication from the market. Continued access must be ensured by transferring the MA to a third party or allowing a third party to refer to the medicinal product’s dossier.
• Choice of reward. Upon grant of a new paediatric indication, applicants may choose between a six-month SPC extension or a one-year market protection extension.

Artificial intelligence and health data

• Data-driven decision-making. The EMA will be expressly permitted to leverage personal health data from clinical trials “and other sources including real world data” to inform regulatory decision-making. The recitals indicate that such “other sources” of health data could include data generated by computational and AI modelling, as well as data from the Data Analysis and Real World Interrogation Network and the European Health Data Space.

Supply obligations and medicines shortages

• Supply obligations. MAHs must supply medicinal products in a Member State when requested, including fulfilling requirements such as pricing applications, procurement procedures, and supply roll-out plans. Failure to supply continuously within three years can lead to loss of regulatory and market exclusivity in that Member State, allowing competitors earlier market entry.
• Shortage prevention plans. MAHs of prescription medicinal products, and other medicinal products identified by the Commission, must maintain a shortage prevention plan. All MAHs must regularly assess potential supply chain risks and take appropriate mitigation measures.
• Notification requirements. MAHs must notify the relevant authorities of any permanent or temporary supply disruptions. Where the disruption is expected to last two years or more, MAHs must provide at least six months’ prior notice to the relevant authorities.
• Union list of critical medicinal products. The Commission will maintain a list of critical medicinal products identified to it by the national competent authorities of the Member States. The Medicine Shortages Steering Group will evaluate supply chain vulnerabilities of these medicines and make recommendations on appropriate security of supply that MAHs must “take into account”.

Next steps

Once formally adopted, the new Regulation and Directive will enter into force on the 20th day following publication in the Official Journal. As always, these are the texts that will be final and binding. The Regulation will be applicable 24 months after its entry into force, and similarly, Member States will have 24 months from the Directive’s entry into force to transpose it into their domestic legislation. The legislative reforms will have a transformative effect on the pharmaceutical industry. If you have any questions regarding preparations for being regulated by the new regime, please contact any member of Ropes & Gray’s Life Sciences Regulatory and Compliance practice or your usual Ropes & Gray advisor.