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.
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