International Recognition Procedure | Harmonizing Medicinal Product Registration across borders

February 6, 2024

A new regulatory recognition procedure for the registration of medical products in the UK has been established. Using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States, this new procedure will allow for an efficient and harmonized approach to the recognition of medicinal products.

This marks the start of a new international recognition framework for medicines that will benefit patients by providing quicker access to medicines that have been approved by other trusted regulatory authorities. Work is underway to establish similar pathways for medical devices.

Check all the updates and changes that the new INTERNATIONAL RECOGNITION PROCEDURE (IRP) will bring.

What type of marketing authorisation applications can the new procedure be used for?

  • Chemical and biological new active substances and known active substances.
  • Generic applications.
  • Hybrid applications.
  • Biosimilar applications.
  • New fixed combination product applications.
  • Post-Authorisation procedures, including line extensions, variations and renewals.

 

Main advantages of the implementation of the new procedure:

  • Efficient and harmonized approach to the recognition of medicinal products: benefiting patients in the UK by providing quicker access to medicines that have been approved by other trusted regulatory authorities.
  • Streamlined process: By incorporating both ECDRP and MRDCRP under the IRP umbrella, process is simplified, complexity reduced, and timelines potentially accelerated.

 

Need help? Contact us at: info@asphalion.com

Or schedule a free 30-minutes meeting here: https://bit.ly/3NwVsNR

Search News & Events

  • Filter by category

Share

Related news and events

EVENT | 20th Biosimilar Medicines Conference by MFE

During these two interactive days, actors of the healthcare community alongside world experts in biosimilar medicines will gather and debate the evolving biosimilar medicines landscape and emerging trends. Discussion will focus on sharing good practices and setting collective aims to achieve the depth, breadth and speed of the use of biosimilar medicines as a lever to untap their transformative value.

New opening! | Pamplona office

At Asphalion, we are thrilled to announce the opening of our new office in Pamplona! This strategic decision reflects our commitment to being closer to

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