skip to main content
Close Icon We use cookies to improve your website experience.  To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy.  By continuing to use the website, you consent to our use of cookies.
Global Search Configuration

train fast run on railway track in sunny day

The UK regulator, the MHRA, has published details of the abbreviated process it will use to assess Great Britain marketing authorization applications (MAAs) for products that have received a positive opinion from the European Medicines Agency’s drug evaluation committee, the CHMP, under the EU’s centralized assessment procedure.

The “European Commission Decision Reliance Procedure” (ECDRP), which offers the possibility of GB approval within 67 days of the application being validated by the MHRA, includes an incentive for companies to file as soon as possible after the CHMP opinion to make sure GB assessment times can be aligned with those of the EU.

A separate process has been implemented allowing the MHRA to take account of marketing authorizations issued under the EU’s mutual recognition and decentralized systems when processing applications for UK or Great Britain approvals. This also offers a 67-day turnaround, but with the possibility of a marketing authorization (MA) being issued within 42 days.

Both procedures involve the submission of all the documentation provided to the EU or national authorities when seeking marketing authorization for the product from the MHRA, which is now a fully standalone medicines and devices regulator following the end of the Brexit transition period on 31 December 2020.

The ECDRP

The ECDRP, which will operate for two years until the end of 2022, allows the MHRA to rely on MA decisions taken by the European Commission (EC) with a view to issuing an MA valid in Great Britain (England, Scotland and Wales). Under the Northern Ireland Protocol, EU MAs will continue to be valid in Northern Ireland, as will EU medicines regulations, while Great Britain goes its separate way.

The intention is for the MHRA to complete its assessment of a GB MAA as soon as possible after the EC decision, and in any case within 67 days – the same timeframe allowed for the EC to make centralized approval decisions after receiving the CHMP opinion.

To use the process, the applicant should submit a letter of intent to submit an ECDRP MAA at least four weeks before submission, once the company is confident of receiving a positive CHMP opinion, “for example after receiving confirmation that no major concerns remain.” The letter should be accompanied by “all iterations of the CHMP assessment reports that have been received to date.”

Once the CHMP opinion has been delivered, the ECDRP MAA should be submitted to the MHRA as an electronic Common Technical Document (eCTD), and should include “the entire dossier as reviewed by the CHMP (and approved by the EC if the EC decision has already been received), including the full responses to CHMP questions.”

If orphan designation is sought, an application form should be submitted. Where submissions will trigger pediatric study requirements, applicants should ensure that the latest EU and/or Great Britain pediatric investigation plan (PIP) waiver opinion/decision or class waiver decision is included in the dossier.

 

The MHRA “will aim to determine the GB MA as soon as possible after EC approval, and by Day 67 at the latest provided that the EC decision has been received" – MHRA

 

The procedure also offers an incentive to file early with the MHRA. If the company provides the CHMP opinion within five days of its adoption, the date of the opinion will be designated day 0 of the ECDRP. The MHRA “will aim to determine the Great Britain MA as soon as possible after EC approval, and by Day 67 at the latest provided that the EC decision has been received.”

If the application is filed more than five days after the opinion, day 0 will be the date of the UK’s validation of the MAA, which means “determination may be delayed.”

The applicant is responsible for confirming the EC decision to the MHRA, and for confirming the opinion of the EMA’s orphan drugs committee (COMP) on orphan designation.

Any issues identified during assessment will be notified to the applicant by Day 46 “and should be resolvable within the 67-day timetable without clock-stop,” the MHRA says. In the unlikely event of major objections or substantial amendments to the product information, “the timetable will move to the standard national procedure timetable.”

The MRDCRP

The mutual recognition and decentralized reliance procedure (MRDCRP) is also intended to produce an MHRA decision in 67 days, although it differs from the ECDRP in a number of respects. For example, the EU procedure must have resulted in an MA decision before the UK process can begin. Moreover, it can be used to apply for either a UK marketing authorization (a product license, or PL) or a Great Britain MA (PLGB), and unlike the ECDRP there appears to be no limit on how long the procedure will remain in place.

To use the procedure, the applicant must send the MHRA the entire dossier of the product approved for marketing in the EU, including the full company responses to questions from the reference member state (RMS) or concerned member state (CMS), as well as all iterations of the RMS assessment reports and the MA grant letter from the RMS. Similar requirements for notifying orphan designation requests and pediatric requirements apply as in the ECDRP.

The MHRA says the first round of assessment of the dossier should be completed by Day 42, “at which point the MA will be granted if no concerns are raised." Any issues will be sent to the applicant, at which point the clock will be stopped for up to 28 days to allow it time to respond. “If there are no outstanding points at Day 65, the MA will be granted within 67 days of MAA validation.”

If the MHRA has major objections, substantial amendments to the product information are needed, or there are other concerns outstanding at Day 65, the timetable will move to the standard national procedure timetable.

Read also

;

Next steps

Whether you’re a small biotech start-up, research firm, generic manufacturer or a global pharmaceutical giant, you need focused, independent insight and opinion on market developments.

Our team is always happy to hear from you. Please call us at:

  • US Toll-Free   : +1 888 670 8900  
  • US Toll             : +1 212-600-3520
  • UK & Europe : +44 (20) 805 20700
  • Australia        : +61 2 8705 6907

Or please submit your inquiry via the form so that we can provide you the best possible customer service.

Have an immediate and specific information need?

Browse and buy from 1000s of analysis and research reports now: