EU Pharmaceuticals reform | Feedback deadline extended

June 29, 2023

The EU Commission submitted its proposals for EU new pharmaceutical legislation (Directive 2001/83 and Regulation 726/2004, including the legislation on medicines for children and for rare diseases) on 26th April, 2023. This is the largest reform in over 20 years, aiming at making medicines more available, accessible and affordable in the EU, among others.

The challenges this reform addresses are fundamental, and some of the key elements of the proposal are:

– Changes in the period of market protection for innovative, pediatric, orphan, repurposing, generic and biosimilar medicines

– Reduction of the timetables for scientific assessments, news on scientific support and simplified regulatory procedures

– New requirements for ERAs

– Measures for:

  1. Increasing the affordability of medicines
  2. Reducing antimicrobial resistance
  3. Future-proofing to make sure that the regulatory system can keep pace with scientific and technological progress
  4. Fight medicines shortages

 

This adopted act is open for feedback. All feedback received will be summarized by the European Commission and presented with the aim of feeding into the legislative debate.

From Asphalion, we can help you understand how this implementation may impact your company.

Do not hesitate and reach out to us now by scheduling a call or sending us an email at info@asphalion.com to get to know all details!

Search News & Events

  • Filter by category

Share

Related news and events

SERVICES | Life-Cycle Management

Looking for a regulatory partner to ensure compliance of your company’s marketing materials? Achieve Excellence in Spanish Promotional Material Compliance with Asphalion!   We help

NEW | User Acceptance Testing (UAT) phase

Asphalion Expert Beatriz Ugalde Dionicio has been selected by the European Medicines Agency (EMA) to participate in the Product Management Service (PMS) Product User Interface

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting