Snapshot

The International Recognition Procedure - Recognition B pathway has been developed by the of United Kingdom.

This pathway can be used where IRP applications will follow Recognition B if any one of the following criteria applies: 1. RR has granted a conditional or exceptional circumstances MA (or international equivalent). 2. A conditional or exceptional circumstances MA is sought in UK/GB. 3. Additional manufacturing sites are cited that have not been assessed by the RR (except for secondary packaging, labelling and QP release sites). 4. There are substantial changes in the manufacturing process or analytical methods compared to what was assessed by the RR. 5. At least one manufacturing site is not yet GMP certified. 6. The Environmental Risk Assessment (ERA) has not been assessed by the RR. 7. The Risk Management Plan (RMP) has not been assessed by the RR. 8. There are UK-specific risk management activities (e.g., which may be reflected as additional pharmacovigilance or additional risk minimisation activities). 9. The RR has mandated one or more post-authorisation safety studies (PASS). 10. The product contains a first-in-class new active substance. 11. The product incorporates novel or cutting-edge technologies. 12. Clinical efficacy or safety data are available for a later cutoff than those assessed by the RR. 13. The pivotal clinical data are from single arm studies. 14. The pivotal clinical data include real world data. 15. Advanced therapy medicinal product (ATMP) as classified by the HMRs 2012. 16. Fractionated plasma product. 17. Application for orphan drug designation. 18. Comparator product used in bioequivalence or therapeutic equivalence study was sourced outside the UK/EU/EEA (generic/hybrid applications). 19. Product is not subject to medical prescription. 20. Co-packaged medical device components are not CE or UKCA marked. 21. Where an IVD is required for correct use, the IVD is not CE or UKCA marked. 22. An approved body or notified body report is not available for integral medical device components. 23. The RR assessment cites guideline(s) that are not adopted by the MHRA. 24. Proposed container closure system, shelf-life or storage conditions differ compared to those accepted by the RR and/or additional stability studies have been provided to MHRA..

This pathway accelerates the regulatory review process.

It is a verification review (a recognition pathway).

When relevant, the agency relies on prior decisions from Australia Canada EU-EMA Japan Singapore Switzerland United States

For initial MAAs, Recognition B procedures will run to a 110-day timetable from validation to allow for consultation with the Commission on Human Medicines (CHM). Submission dates for Recognition B to align with CHM dates for New Active Substances (NAS) will be published in due course. Timetables are calendar days and start once the IRP submission has been validated by MHRA. Suitability for Recognition A or B is determined by means of an eligibility form to be completed by the Applicant 6 weeks before the planned date of MAA submission. Applications that are determined not eligible for Recognition A or B can be submitted as full national applications if MHRA requirements are met.