On April 26th 2023, the European Commission published the adopted proposal for a new directive and a new regulation, revising and replacing the existing pharmaceutical legislations (Regulation 726/2004 and Directive 2001/83/EC) and the legislation on medicines for children (Regulation 1901/2006) and for rare diseases (Regulation 141/2000/EC). This is the largest reform in over 20 years and includes to the regulatory framework (such as changes in market exclusivity and data protection period, reduction in authorization times for new medicines, etc.) that will redefine the pharmaceutical landscape in EU.
This is also a very promising step towards the digitalization of labeling. EC aims to utilize digitalization to streamline procedures, enhance flexibility and reduce regulatory burden.
Here are few excerpts from the published documents:
Specific Objectives: Reduce the regulatory burden and provide a flexible regulatory framework
The revision should increase the attractiveness of the EU regulatory system through simplifying and regulatory requirements and reducing burden for industry and public authorities. The goal is to provide clarity on the regulatory pathways, reduce approval times and costs while maintaining high standards and robust assessment of the quality, safety, and efficacy of medicines. Leveraging digital technology and the use of electronic information could support this objective.
Horizontal measures: The introduction of electronic product information is supported by all stakeholder groups. For healthcare professionals and patients, it is important to keep paper package leaflets in certain cases to ensure access to information for all patients. Member States want that the different national levels of ‘digital readiness’ are respected.
The electronic product information will complement the current paper package leaflet of authorized, statutory information for each medicine, though in certain cases Member States could allow electronic product information only. It could have positive effects on shortages and will be more appropriate to the EU’s multi-lingual environment. The electronic product information will have a limited, positive environmental impact from reducing the number of paper package leaflets and streamlining the logistics chain.
Red Nucleus has been at the forefront of digitized labeling, we are always excited to have a strategic discussion with Life Science companies to partner on optimizations and making digitized labeling a reality. Contact us for more information.