MHRA International Recognition Webinar November 2023

Summary

In November 2023, the MHRA conducted a webinar to discuss the new International Recognition Procedure (IRP) launching in January 2024. The IRP aims to streamline the approval process for medicinal products authorized by trusted international regulators. The webinar detailed the IRP's procedures, eligibility criteria, and its application across the product lifecycle. Key speakers included MHRA executives and experts who elaborated on submitting applications, managing risk plans, and adhering to national pharmacovigilance requirements. The event emphasized the IRP's role in enhancing global regulatory collaboration.

Highlights

• The IRP will replace multiple existing procedures to improve efficiency in product approvals 🚀.
• Recognition A offers a swift 60-day timeline, while Recognition B provides up to 110 days with possible extensions ⏱️.
• Speakers detailed the need for a pre-submission eligibility form six weeks prior to application 📆.
• The emphasis on using Slido for questions ensured a smooth Q&A session despite a large attendee count 🤔.
• Guidance and support documents are available to assist with the transition to the new IRP framework 📚.

Key Takeaways

• The IRP launches in January 2024, simplifying processes for products authorized by recognized regulators 🌍.
• Eligibility for streamlined processes through the IRP involves a detailed pre-submission eligibility form 📄.
• The IRP covers a broad range of products but excludes homeopathic and certain herbal products 🌿.
• Expect two main routes for applications: Recognition A and B, each with specific timelines and criteria 🕒.
• The webinar highlighted the importance of using Slido for Q&A, emphasizing organized themes for efficient interaction 💬.

Overview

The MHRA is set to revolutionize international medicinal product approvals with its International Recognition Procedure, launching in January 2024. Explained in their recent webinar, this initiative simplifies the process for medicines approved by trusted global regulators. This innovative approach is designed to enhance collaboration and ensure efficient, timely approvals, making pharmaceutical innovations more accessible.

During the engaging session, MHRA experts outlined the necessary steps to leverage the IRP, covering eligibility, timeline nuances, and application processes. Key distinctions were drawn between Recognition A and B pathways, emphasizing the flexible yet structured approach to manage varying product approval needs. This ensures swift navigation through the approval maze, with a specific focus on adherence to new guidelines and procedural timelines.

Overall, the webinar not only provided detailed guidance on the transition towards the IRP but also demonstrated MHRA’s commitment to integrating global regulatory insights into their national frameworks. The effective use of Slido for Q&A sessions illustrated how technology facilitates better communication and interaction, ensuring that participants' questions were addressed in an organized manner.

Chapters

• 00:00 - 00:30: Introduction and How to Participate The chapter introduces participants to a webinar on international recognition procedures. It provides instructions on how to participate, specifying that participants are connected via their computer's speaker system by default. It suggests alternatives for joining the session, although these alternatives are not fully detailed in the provided transcript.
• 00:30 - 01:00: Audio Options and Submitting Questions This chapter covers how to use audio options and submit questions during a webinar. It explains that attendees can select 'telephone' in the audio pane to view dial-in information. Additionally, participants can submit text questions at any time using Slido, accessible at www.slido.com with the event code 'hasag IWI webinar 23'. The questions will be collected and addressed during the Q&A session at the presentation's end.
• 01:00 - 01:30: Speaker Introduction - Julian Beach The chapter titled 'Speaker Introduction - Julian Beach' begins with a note informing the audience that questions will not be accepted via the chat function of the GoToWebinar platform. Following this, Julian Beach, the interim executive director of the Healthcare Quality and Access Group at MH, is introduced as the first speaker. Julian starts by thanking the introducer and welcoming everyone to the webinar, which focuses on International recognition and the launch of an undefined initiative planned for January 4, 2022.
• 01:30 - 02:00: International Recognition Procedure Overview The chapter focuses on providing an update on the launch of an international recognition procedure. The presentation is introduced with acknowledgment to the participants, aiming for an engaging and interactive session. Several colleagues from the MH are introduced, including Shery Hopper, the Deputy Director of Innovative Medicines, and Andrea Johnson, the Deputy Director involved in the process. The goal is to keep attendees informed about the advancements and strategies related to international recognition.
• 02:00 - 03:00: Participants and Agenda This chapter discusses the participants involved in a certain authorization life cycle. Mentioned are Allison Shaw from safety and surveillance, JZ Vinda Singh from Innovative Medicines, Jackson from the GMP inspectorate, and Liz Baker, who was formerly at the MH. Liz Baker is noted for helping with the launch of a procedure. The chapter expresses gratitude for the contributions of these individuals.
• 03:00 - 16:00: Shirley Hopper - International Recognition Procedure The chapter titled 'Shirley Hopper - International Recognition Procedure' covers an overview of the international recognition procedure, which includes familiar content for the audience. The key topics include the eligibility form and application submission process, eCTD guidance, updates on fees, and the publication of key performance indicators.
• 16:00 - 25:00: Andrea Johnson - Eligibility Checker The chapter titled 'Andrea Johnson - Eligibility Checker' involves an update on existing guidance. This is followed by an interactive Q&A session, starting with pre-submitted questions. Due to the large number of participants, individual questions might not be addressed. However, efforts will be made to cover as many questions as possible centered around the same themes.
• 25:00 - 31:00: Submission Process and Guidance The chapter titled 'Submission Process and Guidance' begins with an introduction to using the Slido function for submitting questions, emphasizing its preference over the chat function. Shirley Hopper is then introduced, who will be providing an overview of the international recognition procedure. The chapter aims to guide the reader through the submission process, helping them understand the importance of using designated functions for efficient communication and the subsequent steps involved in gaining international recognition.
• 31:00 - 35:00: Updates on Fees and Key Performance Indicators The chapter discusses the publication of guidance at the end of August, marking the first such publication. This guidance includes a list of acceptable reference Regulators. Additional follow-up guidances have since been released, which will be further elaborated upon by Andrea.
• 35:00 - 39:00: Existing Guidance and Closing Remarks The chapter discusses the existing guidance related to regulatory frameworks in Europe. It mentions the involvement with regulators through access and Oris, indicating prior collaborations. There is a reference to the access Consortium approvals being applicable for IRP, specifically mentioning MH. These points seem to serve as concluding remarks about the regulatory processes and pre-existing relationships with these regulatory bodies.

MHRA International Recognition Webinar November 2023 Transcription

• 00:00 - 00:30 hello everyone and welcome to today's webinar International recognition procedure before we get started I'd like to go over a few items so you know how to participate in today's event you have joined the presentation listening using your computer speaker system by default if you would prefer to join Over the the
• 00:30 - 01:00 telephone just select telephone in the audio pane and the dial-in information will be displayed you will have the opportunity to submit text questions via slido at www.slido.com using the event code hasag IW I webinar 23 you may send in your questions at any time during the presentation we will collect these and address them during the Q&A session at the end of today's presentation
• 01:00 - 01:30 please note that we will not be accepting questions via the goto webinar chat function it is now my pleasure to introduce your first Speaker Julian Beach interim executive director of healthc care quality and access group MH thank you and good morning um and welcome to the the webinar on International recognition and the launch of this for the 1 of January 202 um 4 is
• 01:30 - 02:00 making sure I get the right year I'd like to thank you all for joining and I'm looking forward to a really good interactive session we are looking to provide an update on what we're doing for the launch of the international recognition procedure so I am joined by a number of colleagues from the MH so with me on screen I have shery Hopper deputy director of innovative medicines Allison John sorry Andrea Johnson um deputy director for
• 02:00 - 02:30 authorization life cycle also with me I have um Allison Shaw from safety and surveillance JZ vinda Singh from Innovative medicines in Jackson from our GMP inspectorate and I'm also joined by Liz Baker um who is formerly at the MH who is helping us with the um launch of this procedure so I'd like to thank all of those people for their participation
• 02:30 - 03:00 and and I look forward to a good webinar so if I can have the next slide so what we will be intending to cover is an overview of the procedure some of it you will have seen before quite a lot of it you would have seen before the eligib eligibility form and how to submit applications the ectd guidance an update on fees publishing key performance indicators
• 03:00 - 03:30 an update on existing guidance and then we will have a in an interactive Q&A session we will start that Q&A session with some pre-submitted questions so thank you to those um who have pre-submitted and then we will be looking to theme questions so the individual questions as we go through the Q&A session may not be answered because of the numbers of people on the call but what we will be trying to do is to answer as many of the same theme
• 03:30 - 04:00 questions to get as many of those answers out there for you um but as I say if you can use the slido function to submit any questions rather than the chat function on the web web tool so firstly if I can hand over to Shirley Hopper to take us through the first part of this thank you very much Julian so I'm going to provide an overview of the international recognition procedure uh next slide please
• 04:00 - 04:30 so um we publish guidance at the end of August um this was the first guidance that we published um and um as Andrea will be touching on later um we've now published a number of follow-up guidances so um this guidance um provides a list of the reference Regulators um which will be acceptable for use um for the
• 04:30 - 05:00 IRP so um these are Regulators that we have worked with before uh through I uh through access um through Oris um or um when as part when part of the uh European regulatory framework so um you'll be familiar with this list um it's also possible to use um access Consortium approvals um for IRP um if MH
• 05:00 - 05:30 um was not included in the initial work sharing procedure and the applicant chooses one of the trusted Regulators within the access Consortium as the reference regulator and you'll also note that for the European Union as well as EMA um in individual member State competent authorities um can be reference Regulators um as well as approvals um via the MRP uh DCP um and for this reason
• 05:30 - 06:00 um the international recognition procedure um will be replacing um ecdp and um the mrdc Reliance procedure uh next slide please yes so um we um are offering this procedure alongside um our national licensing routes from the 1 of January
• 06:00 - 06:30 20 24 um and these National licensing routes are unchanged so that would include our national um route um which will be unchange from that um which commenced at the beginning of January 2021 um and also the uh project Orit and the um access routs that you will be familiar with um so as I've already said IP replaces ecrp um and also the mrdc RP
• 06:30 - 07:00 um so it's open to applicants who have received an authorization from a reference regulator for the same medicinal product um there has to have been a full Standalone review by the reference regulator so we can't do recognition on the top of a previous Reliance or recognition and the authorization by the reference regulator must be within 10 years for initial marketing authorization application
• 07:00 - 07:30 and the MH will conduct a targeted assessment of the dossier um based on the uh reference regulator assessment reports um and IRP uh does cover the product life cycle um and I'll be touching on this a bit later uh next slide please so um the majority of product types are covered by IRP including new active substances uh chem and
• 07:30 - 08:00 Biologicals um also generic medicines including hybrid applications uh fix combination products um and vaccines and biosimilar um but it does not um include uh traditional herbal and homeopathic products um or um bibliographic wellestablished use applications uh next slide please okay so um there are are two different uh routs um for initial
• 08:00 - 08:30 marketing authorization applications and also line extensions um so there's recognition a which is 60 calendar days with no clock stop and recognition B which is 110 calendar days and that allows for a clock stop at Day 70 if required um and the clock stop um can be up to 60 days um for for recognition a um if
• 08:30 - 09:00 issues cannot be resolved within 60 days the timetable May revert to recognition B and for recognition B um if there are outstanding major objections um by day 110 then the recognition B timetable uh May revert to the National timetable um so the purpose of having these two uh timetables um and fees is to enable a fast approval of those IRP
• 09:00 - 09:30 applications which require limited assessment and these timetables um do compare favorably with our national assessment timetables um which currently run between 150 and 210 days um suitability for recognition A or B um will be determined by completion of the pre-submission eligibility form um and
• 09:30 - 10:00 we've just released new guidance um about this um and Andrea Johnson will provide more detail um in in in a while um but this uh form needs to be completed six weeks before submission and in a few cases MH triage may be needed to determine whether route A or B is applicable um and this will be done for
• 10:00 - 10:30 submission and applications that are unsuitable for recognition A or B um can be submitted by the national route uh next slide please so to be eligible for recognition a the reference regulator approval needs to be within two years um the manufacturing process needs to be essentially the same as that approved by the reference regulator with evidence of compliance with GMP at submission and none of the recognition B criteria
• 10:30 - 11:00 should be met next slide please so um a full description of the recognition B criteria um is provided in uh the main guidance um but some of the key um criteria are listed here um the for B the reference approval reference regulator approval should be granted within the pre previous 10 years
• 11:00 - 11:30 um and the other criteria include um if the reference regulator has granted a conditional ma or ma under except exceptional circumstances or the international equivalent of that and or this is sought in a UK or GB then a recognition B will apply recognition B will also apply if compared to the reference regulator assessment that are additional manufacturing sites or substantial
• 11:30 - 12:00 changes in the manufacturing process or the analytical methods or different proposed container closure system shelf life or storage conditions um recognition B will apply if at least one manufacturing site does not have GMP certification at the time of submission and it also applies for certain product types including atmps um orphan drugs and overthe
• 12:00 - 12:30 counter products and also there are some aspects of the risk management plan which should make um a product recognition B and I'll touch on this um next um so next slide please so um the risk management plan to be submitted to the application must follow the EU um rmp template and where appropriate um the GB or UK specific spefic rmp Annex um together with the
• 12:30 - 13:00 approved EU rmp can be used and um there is uh details of this um on our guidance um on pharmac Vig procedures now if the reference regulator has not assessed the rmp which format that we require so the um EU format or um they have assessed it in a
• 13:00 - 13:30 different format um to the one for the UK um then recognition B will apply because we will need to carry out um a full assessment of the risk management plan um and recognition B will also apply whether are UK specific risk management activities or where the reference regulator has mandated um at least one pass next slide please so um there are um National pharmac vigilance
• 13:30 - 14:00 requirements that will apply um in the case of international recognition so um there are UK requirements for um individual case safety reports and uh psurs and also IRP is not a substitute for the Mah's responsibility for submitting pharmac vigilance data and information to the MH um and keeping the license up to date with scientific
• 14:00 - 14:30 knowledge and where are new data which may impact the uh benefit risk and particularly where the clinical management of patients might be affected uh the MH should be informed as soon as possible and variations which impact on patient safety will be assessed in the context of the UK uh clinical con uh clinical situation um and we may need to require we may need to assess these V route um
• 14:30 - 15:00 if there are specific uh UK considerations next slide please so International recognition does cover the product life cycle um and uh the time frames um for IRP will be the um existing time frames for these type of applications um the exception to this is line extensions which are following the route a or the route B so for life cycle
• 15:00 - 15:30 applications that um are not a line extension recognition A or B does not apply um so you can apply for type 1B and type two variations via International recognition um you can apply for renewals including annual re of CMAs and annual reassessment of masas under exceptional circumstances um but all other types of postmarket
• 15:30 - 16:00 applications are National only um and it should be noted that it is it is the UK equivalent of um the applications so for example type 1B and type two that will apply so um during the life cycle it is recommended that the same reference regulator is used um for the IRP applications um however there may be occasions where you
• 16:00 - 16:30 may wish to use um a different reference regulator um and this is allowable um if it is Justified for example um it may be a new indication um which um would allow um earlier access for patients in the UK um and you don't need to completely eligibility form for variations that is only for initial Mas and line extensions um and for all variations you
• 16:30 - 17:00 complete the usual application form and the ectd sequence uh needs to be submitted and but you do need to include in the cover letter that this is a recognition recognition procedure and who the reference regulator is okay so I'm going to hand over to um Andrea Johnson now for the next part of the uh presentation thank you Shirley and hello um next slide
• 17:00 - 17:30 please I'm happy to announce that the eligibility Checker went live on the 20th November so it's now accessible uh from our International recognition procedure pages and you will see a boxed area where you can easily access the form uh to enable you to be able to complete it we also have provided some guidance on those pages and I'll go through that in a little uh more detail towards the end of the presentation the first thing I would
• 17:30 - 18:00 like to do is say thank you very much to the a few industry reps who actually did some testing for us so that we could get this beta version of the form out and accessible we did receive some feedback from them and we modified a couple of questions that were a little bit ambiguous and therefore we removed them um but also the general feedback was that it was easy to use um there was some other elements that they raised and
• 18:00 - 18:30 we will look to have a a view of whether we can release these later in later iterations of the version but right now we want stability of the form so we'll be leaving it how it is for a little bit um so as I've said we've included guidance to complete the form and how to submit this and it includes details of also how to submit your marketing authorization because the eligibility Checker only applies to initial applications there are some other types
• 18:30 - 19:00 of application that are not allowed via the form but we've kept them in just so that you don't end up completing the form when you don't actually need to you will get a warning saying that um it's not an appropriate way you don't need to submit this for National applications for example and for variations or certain any variations but you will have to complete it for all initial applications and that must be completed
• 19:00 - 19:30 for all of the initial applications irrespective of who the reference regulator is so even if you're using the EMA or if you're using mrdc as a reference regulator you must complete the eligibility form um just a couple of points to note the form um we had some feedback from industry Labs that on occasions they couldn't actually save the PDF because the form will give you a series of questions and then it will give you the
• 19:30 - 20:00 result and you have to save the PDF so it is worth checking with your it Department before you start completing the form just to make sure that you've got no problems with saving the outcome next slide please so I'm going to take you through how to apply uh and step by step procedure next point please so for the initial application you will need to obtain a product license number next uh
• 20:00 - 20:30 point please and to obtain that you need if you're not already registered with us you need to register to get your five-digit code if you're an existing company you should have that and get your PL number Next Step then we're going to use the form to determine which recognition procedure applies Next Step please so 6 weeks before you intend to submit your application use the eligible Checker to determine the loot the
• 20:30 - 21:00 Checker actually has inbu coding to tell us whether it's going to be an A A B A triage and you need to save as I've indicated that form so that you're ready to submit Next Step please so deciding which way you need to submit we actually have this in the guidance but in in natural fact the form includes all of the information it includes all the relevant information so it will tell you what to to do with the application form when you get it but
• 21:00 - 21:30 just to go through those points if it indicates the recognition A or B then submit the form with your MAA application via the mhr submissions platform and the human medicines Tab and that's very important I'll come on to that in the next slide but uh you must submit via that rout so if it comes out A and B and it's not a new active substance then you can just include it in your application and and uh proceed to submit that
• 21:30 - 22:00 application next please if it indicates that it's triage and there are a few questions very few questions that will actually require this then you submit the form six weeks in advance to the uh uh to the mhra recognition mailbox and we will then look at it tried make a decision and we anticipate to be able to do that within 10 days of the seat of these and once we have done
• 22:00 - 22:30 that we will inform you via email what the outcome is what you should then include is both the Tre both the eligibility form and the outcome in your MAA submission Next Step please for new active substances where the eligibility indicates as a recognition A or B we still want to see these six weeks in advance because you know nor would give us early notification that you're going to submit
• 22:30 - 23:00 a new active substance so this form will it give us that indication so even if it's an recognition a or recognition B for new active substance then please submit to the mhr recognition mailbox you won't receive anything other than a notification from US to indicate that we've received that and you can submit your application with the eligibility form in uh 6 weeks in 6 weeks time and
• 23:00 - 23:30 next one please obviously if it's a new active substance and it requires triage then we will go through the normal triage process and inform you of the outcome uh and so that you've got time to submit your application as well and include the outcome and the information and the Checker in your ectd submission um as I indicated all of this information actually appears on the eligibility form when you've completed
• 23:30 - 24:00 it so it's in the guidance um and it's on the eligibility form so hopefully easy to follow next slide please as I indicated any International recognition procedure that's for your marketing authorization application or your product life cyle applications need to come through the mhra submissions platform using the human medicines tab there is no other submission loot that
• 24:00 - 24:30 is acceptable for this when you do come on to this and if you're not if if you don't have this we have instructions of how to register so that you can actually access this but when you do come on to it you will notice for those who are more familiar with using it that there are some new regulatory activity dropdowns and descriptions to use um so if you're submitting a marketing authorization application you need to indicate whether this is a marketing authorization Nas and which looted is a
• 24:30 - 25:00 or b or if it's not a Nas which looted is a or b um and for variations and renewals obviously as Shirley has indicated there are certain types of uh variation type 1bs and type twos and some renewals that are applicable for international recognition so you choose the appropriate one there is a split in the variation type two to include if it's if you're type two includes a new indication or if it excludes a new
• 25:00 - 25:30 indication next slide please so we have updated and provided some ectd guidance next slide please I'm not going to go through every aspect of what's in the guidance but just give you some key San points the guidance actually tells you the content the format requirements of completion of an ectd and it covers both initial applications and variations and renewal
• 25:30 - 26:00 applications the guidance doesn't go into uh great detail about the types of assessment reports Etc that are required to be included but that information is included in the initial uh guidance that we provided about IRP just to give you an overview of what is required so for initial applications all modules of the ectd should be in the EU format so that's modules 1 to 5 there
• 26:00 - 26:30 will be some specific UK information that needs to be included in module one and you must include some of the information in the cover letter or the subfolder to the cover letter we in addition have asked for some data to be CL included in M1 additional and all of the requirements and all of the formats by which you should do that are covered in the ectd guidance the ectd module 2:5 should include all relevant information
• 26:30 - 27:00 required for the MH application and this will be a baseline of the required information is approved by the reference regulator at the time of submission to the mhra but also anything additional that we require for uh the mhr's submission all of these need to comply with any EU Regional requirements of the I ectd standard next slide
• 27:00 - 27:30 please variations very similar so all modules ectd should be in the EU format module 1 to5 with UK specific information in module one cover letter additional areas it's all in our guidance your cover letter because you don't fill in an eligibility form should include who the the regulator is and that you're using the the the application and indicate who that this is an international recognition
• 27:30 - 28:00 procedure ectd modules 2 to5 should include all the relevant information required for the mhr application and should be a Consolidated sequence of the required information that was approved by the reference regulator at the submission date to the MH next slide please uh next slide please thank you we have uh updated the fees so our fees
• 28:00 - 28:30 page is now updated to include the required fees for international recognition procedures so please check those out those fees follow the existing Reliance fee loots and we will keep this under review during initial phases of implementation and align any modification with the agency standard fee cycle next slide please we do intend to publish key performance indicators as we do today
• 28:30 - 29:00 next slide please and it is Our intention to use the existing Publications we provide today so for loot a and loot B that will cover the medium time to determination and the number of applications that we've received and it will also cover the time to validation for variations it will be as our existing Publications we will keep these under review during the initial phases of implementation and we'll decide whether additional
• 29:00 - 29:30 information needs to be provided as well so if you have thoughts on this you please feel free to pass them on and we can consider those move forward next slide please next slide please thank you uh so just to give you an update on the existing Gap that we've done um so Charley showed you what we
• 29:30 - 30:00 had for our initial recognition pages on the same page you will find some additional information the supplementary information was published probably around um the earlier part of November and it was from feedback that we were receiving questions Etc that were coming up on a regular basis so we updated and gave some feedback on those things so use the two things to help you to consider what you need to do for it International recognition procedures the new elements that are
• 30:00 - 30:30 there since the 20th of November are obviously the eligibility Checker itself which I showed you earlier but we've also given guidance for the eligibility Checker and submitting marketing oranization we've given guidance for the product life cycle so how to apply for variations and renewals into IRP and we've also published the ectd guidance for IRP masas and also for Life Cycle Products thank you very much to all of
• 30:30 - 31:00 the uh contributors to this and I hope that um people found this useful we will be looking to see how we can update our guidance to incorporate some of the other questions so as I mentioned that we will be um learning as this process goes forward so that we will then as we can do update guidance and issue update as to how we will be handling procedures
• 31:00 - 31:30 going forward so if there are find any other remarks from Shirley or Andrea I'd just like to thank everybody again and draw it to a close