Faster, safer, more innovative: an overview of the EU pharmaceutical package

On 11 December 2025, the European Parliament and the Council of the European Union reached agreement on a comprehensive reform of European pharmaceutical legislation: the EU Pharmaceutical Package. The political agreement must now be endorsed and formally adopted by both legislative bodies before it enters into force upon publication in the Official Journal. 

The EU Pharmaceutical Package is the most far-reaching overhaul of European pharmaceutical law in around 20 years. The reform pursues key objectives: simplifying authorisation procedures, strengthening supply chains, facilitating access to medicines in the EU, promoting innovation and combating antimicrobial resistance. 

Key components are 

• a recast of the Directive on the Community Code relating to medicinal products for human use, and
• a new regulation intended to replace Regulations (EC) No 726/2004 (authorisation and supervision of medicinal products) and No 141/2000 (orphan medicinal products), as well as parts of Regulation (EC) No 1901/2006 (paediatric medicinal products). This is intended to fundamentally modernise the existing legal framework.

Changes to the authorisation procedure

The reform is intended to make authorisation procedures more efficient and predictable. The duration of the review and authorisation process for centralised procedures at the European Medicines Agency (EMA) is to be reduced from the current 210 days to 180 days. The EMA will also be granted new powers and is expected to further digitise and harmonise procedures. 

Applications will in future have to be submitted to the EMA electronically, and package leaflets must also be provided in digital form. To further reduce the administrative burden, marketing authorisations are to be valid indefinitely in future. However, the EMA may deviate from this in justified exceptional cases. 

Security of supply and new obligations to prevent shortages

The COVID-19 pandemic and recurring supply shortages have highlighted the need for more robust supply security and exposed weaknesses in the existing regulations. The pharmaceutical package therefore contains numerous provisions to strengthen the resilience of supply chains and improve cooperation between authorities and industry. 

Manufacturers will in future be required to report shortages at an early stage and draw up appropriate shortage prevention plans. In addition, EU-wide mechanisms for analysing shortages are to be introduced, for example through an EU-managed list of critical medicines whose availability is continuously monitored. Furthermore, special crisis instruments are to be created to enable a rapid and needs-based response in exceptional situations.

Strengthening innovation

The reform also places greater emphasis on differentiated incentive systems to promote innovation in a targeted manner.

Central to this are the protection periods: companies that bring a new medicinal product to market will continue to benefit from an eight-year ‘data protection period’. Data protection means that during this time, competitors may not access the preclinical and clinical data of the marketing authorisation holder, and the companies retain exclusive rights. Only after this period can other companies use the data to manufacture generic medicines. 

A new development is that market protection will in future last for only one year – one year less than previously. This means that during this period, companies can enjoy an exclusive right to market a product without immediate competition from generics or biosimilars. In the case of innovative medicines that meet an unmet medical need, satisfy comparative clinical trials, or where additional therapeutic indications with proven clinical added benefit are authorised, this period may be extended by up to twelve months. 

If companies invest in medicines for rare diseases (so-called orphan drugs), data and market protection can even be extended to a maximum of eleven years. However, this is subject to the condition that these are particularly innovative medicines addressing a previously unmet medical need. These protection mechanisms are intended to drive development in this area and encourage companies to invest in this type of medicine, as well as to cushion any high research and development costs. 

Combating antimicrobial resistance (AMR)

To promote investment, the EU is also providing additional incentives in the fight against antimicrobial resistance. The EU pharmaceutical package provides for the introduction of a new voucher system, known as Transferable Exclusivity Vouchers (TEV). Through the TEV, the data protection period for a medicinal product can be extended by one year. This is intended to support the development of priority antibiotics to combat antimicrobial resistance. The use of these vouchers is flexible: the pharmaceutical company is free to use the TEV either for the priority antibiotic itself or for another centrally authorised medicinal product belonging to the same marketing authorisation holder. Transfer to third parties is possible. 

However, a restriction is to apply in addition via the ‘blockbuster clause’. This stipulates that the transferable voucher may not be used for products with an annual gross turnover of more than EUR 490 million in the four years following authorisation. This is intended to limit the impact of the voucher system on national healthcare budgets. 

Conclusion and implications for practice

The EU pharmaceutical package marks a profound change in European pharmaceutical law. The reform creates new opportunities for innovation and for strengthening Europe as a pharmaceutical hub, but at the same time presents companies with significant regulatory challenges. Those who integrate the new requirements into their strategic planning at an early stage can secure competitive advantages and minimise risks. 

The proposed changes are to be welcomed as a decisive step towards a more resilient and dynamic life sciences sector in Europe. It remains to be seen whether the ambitious goals envisaged by this reform can actually be achieved.