Marketing authorisation - International Recognition Procedure confirmed
From next year, organisations holding marketing authorisations (MA) in an approved list of countries can benefit from a new 'International Recognition Procedure' to gain access to the UK market.
The delays in receiving the MAs that are required to be able to sell pharmaceutical products in the UK market has been well documented since the major changes brought about by Brexit. In addition, there have been concerns raised about the UK ceasing to be a market of choice for new medicines. In a positive move for the UK, the MHRA has announced that a new International Recognition Procedure (IRP) will be effective from 1 January 2024.
This will replace the European Commission Decision Reliance Procedure (ECDRP) and incorporate the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP). So, what does this mean?
In a sentence, applicants that have already received MAs for the same product from one of the listed 'Reference Regulators' can apply for a UK MA using an expedited recognition procedure that will follow either a 60 or 110 day timetable.
This sounds good in principle, so let's drill down into the specifics.
What is the 'same product'?
The same product is defined as having the same qualitative and quantitative composition (active substance(s) and excipients), and the same pharmaceutical form, from applicants belonging to the same company or group of companies or which are 'licensees.'
Who are the 'Reference Regulators'?
Acceptable Reference Regulators under the IRP are:
- the Therapeutic Goods Administration (TGA) in Australia
- Health Canada
- SwissMedic
- the Health Science Authority Singapore (HSA)
- the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan
- the Food and Drug Administration (FDA) in the United States
- the European Medicines Agency (EMA)
- regulators of the EU member states
What MAs can be applied for?
IRP can be used for various types of marketing authorisation applications under the Human Medicines Regulations 2012 (HMRs), including chemical and biological new active substances and known active substances, generic applications, hybrid applications, biosimilar applications, and new fixed combination product applications.
However, Traditional Herbal Registrations, Homoeopathic, Homeopathic National Rules Authorisations, and Bibliographic applications are excluded from IRP. IRP can also be used for post-authorisation procedures including line extensions, variations, and renewals.
In terms of the Reference Regulator MA being relied on, the assessment must have undergone a full and standalone review. Reference Regulator assessments based on reliance or recognition cannot be used to support an IRP application.
The big picture
The ECDRP was introduced as a temporary measure following the UK's exit from the EU to avoid significant variance from EU licensing pathways and duplication of effort.
While the ECDRP provided market stability following the UK's exit from the EU, the new international recognition framework will bring significant changes. The IRP will allow for an abridged assessment of certain products by recognising approvals from trusted partner agencies worldwide, increasing opportunities for global collaboration and the number of routes to access the UK market. The new framework will also empower the MHRA as a sovereign regulator as it will be responsible for approving all 'recognition route' applications.
The effect of the change is yet to be seen, but this appears a very positive step in encouraging more companies to take the step to access the UK market.