The ECDRP (EC Decision Reliance Procedure) is coming to an end on the 31st December 2023 and will be replaced from the 1st January 2024 by the IRP (International Recognition Procedure). This new procedure will be open to applicants that have already received an authorisation for the same product from one of MHRA’s specified Reference Regulators (RRs):
Australia (TGA), Canada (Health Canada), Switzerland (SwissMedic), Singapore (HSA), Japan (PMDA), United States (FDA), European Union (EMA) and Member State Competent Authorities (This includes approvals through the centralised, MRP/DCP and individual member state national routes).
The implementation of IRP will enable the MHRA to carefully consider the valuable expertise and decision-making abilities of reliable regulatory partners, ultimately resulting in improved outcomes for patients in the UK. While the MHRA will conduct a focused evaluation of IRP applications, it will also possess the necessary authority to decline applications that are deemed to have insufficiently strong evidence.
There are two recognition timetables for initial MAAs:
- Recognition A: 60-day timetable
- Recognition B: 110-day timetable
Applicants are requested to complete an eligibility form 6 weeks prior to their planned MAA submission to determine their suitability for Recognition A or B.
To be eligible for Recognition A, the RR approval must have been granted within the previous 2 years. If Major Objections are identified which cannot be resolved within 60 days, the timetable may revert to Recognition B.
To be eligible for Recognition B, the RR approval should have been granted within the previous 10 years.
If an application does not meet the criteria for Recognition A or B, it may still be submitted as a full national application if it complies with the requirements set by MHRA.
IRP can also be used for post-authorisation procedures including line extensions, variations and renewals. Generally, it is recommended that the same RR is used for IRP applications throughout an individual product lifecycle. Changes of RR during the product lifecycle should be highlighted in the post-authorisation procedure cover letter.
Regulatory Pharma Net provides full regulatory assistance during the whole product lifecycle and is ready to support companies on all regulatory needs and to guide them through any new MHRA requirement/procedure.