Medicines: get scientific advice from MHRA

Overview

You can ask the MHRA for scientific advice fromat theany Medicinesstage andof Healthcareyour productsmedicine’s Regulatorydevelopment Agencyor (regulation. 

You can ask for written advice only, or a meeting. After some meetings the MHRA) atwill anyprovide stagea written summary of theadvice initial(see developmentthe Types of yourmeeting medicine,section beforefor youmore information haveon submittedwritten youradvice applicationprovided after meetings). 

You can ask for specific advice on a marketingsingle authorisationdevelopment (MA)programme (productor licence)product andlifecycle, duringor thebroader pre-submissionadvice periodnot forlimited to a variationsingle todevelopment anprogram existingor MA.product lifecycle.  

MeetingsYou can alsoask befor helda meeting with the MHRA toonly, discuss:or a joint meeting with the MHRA and the National Institute for Health and Care Excellence (NICE). 

• pharmacovigilance
• advertising
• proposals

  The toMHRA changeadvice labellingis orbased packageon leaflets

• post-authorisationthe regulatoryquestions and documents you provide. The advice relatingcannot toaccount afor productfuture range

YouScientific canadvice requestfrom athe broaderMHRA scopeis scientificnot advice.legally Thisbinding wouldfor coverfuture broaderapplications issuesof andthe woulddiscussed product. You should not relateconsider tothe onlyadvice 1as developmentan programmeindication orof product.a future agreed position. 

You

Process canand alsotimelines 

After you have aasked jointfor meetingadvice, withthe MHRA andwill Nationalacknowledge Instituteyour forrequest Clinicalwithin Excellence10 (NICE).working days.  

ScientificThe time it takes to get written advice givenor byadvice via a meeting depends on the subject matter and expertise needed. We strongly encourage early planning and sending of advice requests. 

For meetings, you must send your final questions list and briefing document to the MHRA isat least 3 weeks before the meeting date. If you do not legallydo bindingthis, forthe anymeeting futurewill applicationbe ofdelayed.  

After some meetings the productMHRA discussed,will eitherprovide ona written summary of advice (see the partTypes of meeting section for more information on written advice provided after meetings). If offered, the MHRA orwill thesend company.this Advicefinal can’tadvice beletter takenwithin as6 indicativeweeks of anythe futuremeeting agreedtaking position.place. 

MHRA expertise on offer  

The MHRA’s answershas areextensive basedexperience and expertise to answer questions on your medicine’s lifecycle. To get the submittedbest questionsadvice and documentationaccess andthe cannotmost accountrelevant forexperts, futurethe changesquestions andyou developmentssend in scientificadvance knowledgeshould orbe regulatoryclear requirements.and specific. 

For advice on writing questions, go to the Supporting document guidance section.  

Types of advicemeeting 

Scientific advice meeting 

The questions you ask MHRA haveprimary toadvice beservice asis precisetargeted andscientific clearadvice asfor possible.individual products. 

TheWhile questionswe shouldoffer addressadvice specificat scientificany issuesstage on:of your medicine’s lifecycle, we particularly encourage organisations to request advice at the following points:  

• quality

  first aspectsin (eghuman thestudies: chemical,get pharmaceuticalguidance andon biologicaltranslating testingsafety necessaryand tonon-clinical demonstratedata theinto qualitykey ofclinical atrial medicinal product)designs 

• non-clinical

  design aspectsof (egpivotal theclinical toxicologicaltrials: receive advice from clinical trials and pharmacologicalmarketing testingauthorisation necessaryassessors toon demonstratedesigning thepivotal studies, ensuring appropriate safety ofstudies aand medicinalclinical product)endpoints are chosen to determine safety and efficacy 

• clinical

  chemistry, aspectsmanufacturing (egand endpoints,control trial(CMC)/biological duration,process targetrequirements population,for choicemarketing ofauthorisation: comparatorget etc)

• pharmacovigilanceadvice plansfrom quality and post-authorisationpharmaceutical safetyassessment studyteams protocols
• anon applicationchemical and biological processes for anew variationactives, orpharmaceutical renewalformulations, and stability protocols 

• advice

  design beforeof publishingbioequivalence advertisingstudies for ageneric medicinalmedicines: productidentify the best approaches to bioequivalence studies for off-patent medicines 

• changes

  reclassification toand labellingrepurposing ofprogrammes: packagingreceive leafletsadvice foron medicinalclinical productsand orregulatory aaspects productto rangeensure high-quality applications through these programmes 

WeThe preferattendees thatand theformat questionsof these meetings can vary but will be mutually agreed in advance.  

These meeting are prospectivetypically andwell concernstructured. theMeetings futurelast developmentup ofto a90 medicinalminutes. 

We product.provide written advice after the meeting. 

Broader scope meetingsadvice meeting 

AThe broaderMHRA accepts requests for advice across the entire medicine lifecycle, focusing on our areas of expertise. Broader scope meetingadvice ismeetings are usually not about a product-specificspecific request.product. Examples include:of meetings include: 

• general approaches to product developmentdevelopment 

• overall product development plans wherewith therecomplexities are very broad issues that may go beyond what can be discussed at a routine scientific advice meetingmeetings 

• complex

  discussion issues of complex drug/device combination productsproducts 

• choice

  choosing (includingstudy relativeendpoints, including pros and cons) of study endpoints in particular indicationscons 

• practical issues of study design, management and analysisanalysis 

• risk management plans and other post-licensing aspectstopics 

• legal reclassification of products from prescription-only medicine (POM) to pharmacy (P)(P) medicine or from P to general sales list (GSL)(GSL) 

WeThe willattendees stilland needformat someof briefingthese material for broader scope meetings beforecan thevary meetingbut andwill abe generalmutually ideaagreed ofin theadvance. sortsThey ofcan issues/questionsinclude thevarious sponsor(s)contributors wishsuch toas discuss,external butexperts theand meetingpatient willrepresentatives. beBoth muchparties lesscan structuredinvite thanparticipants. typicalSome scientificmeetings advicework orbest pharmacovigilancewhen advice meetings.

It may be appropriate for the sponsor(s)sponsor togives givea an extended presentation andfollowed thenby there can be a discussion aroundby the issueswider raised. Meetings will still be planned for up to 90 minutes.group.  

These meetingsmeeting mayare includetypically aless varietystructured ofthan contributorstypical includingscientific externaladvice experts and lay or patientpharmacovigilance representatives.meetings. EitherMeetings orlast bothup partiesto can90 invite participants. The overall composition of the meeting will be by mutual agreement.minutes. 

MHRASince will charge a fee for broader scope meetings.

As these meetings are more wide-ranging and more speculative, the MHRA willdoes not giveprovide written advice after the meeting.afterwards. 

These

Joint meetings are requested in the same way as standard scientific advice meetings.

Meetings with the MHRA and NICE   

YouThe MHRA can choosealso toparticipate askin for a joint scientific advice meetingmeetings with the MHRA and the National Institute for HealthcareHealth and Care Excellence (NICE).). 

AtIn these meetingsmeetings, you willcan be able to discuss clinical study designdesigns that canmeet satisfyboth regulatory and NICE’s health technology assessment requirements. You can also get optional input from the MHRA Clinical Practice Research Datalink (CPRD). 

The (CPRD).attendees and format of these meetings can vary but will be mutually agreed in advance. Meetings last up to 3 hours. 

FollowingAfter the meeting, the MHRA and NICE will each produce separate advice documents to answer the respective questions raised.raised. 

A

Ask casefor studyscientific detailingadvice  

The aAsk successfulfor joint scientific advice meetingform thatwill theguide MHRAyou andthrough NICEthe hadsteps withto therequest Universitya ofmeeting Birminghamor written advice.

Ask

Use this form for scientificany type of advice

Submit theor MHRAmeeting -request. RequestThe forfirst scientificpage adviceof the form (MS Wordexplains Document,what 267you KB)will need to scientific_advice@mhra.gov.uk.prepare before you start. 

On

After the form is completed 

The MHRA will aim to acknowledge your request within 10 working days.  

If you shouldrequested include:a meeting, a mutually agreed date will be set. 

• therapeutic

  You area

• scopemust ofdeliver advicethe beingrequested sought
• numberdocumentation, ofincluding companyyour staffbriefing expecteddocument and final questions list, to attendthe (noteMHRA thatat forleast a3 weeks before the meeting withdate.  

  After some meetings the MHRA Divisionwill provide a written summary of Vigilanceadvice and(see Riskthe ManagementTypes of Medicinesmeeting (VRMM)section thefor companymore attendeesinformation shouldon bewritten limitedadvice toprovided 4)

• preferredafter meetingmeetings). datesIf andwritten datesadvice tois avoid
• aavailable, draftthe listMHRA will send this within 6 weeks of the proposedmeeting questions

Supporting document guidance 

AThe mutually-agreedAsk datefor scientific advice form will thenprompt beyou set.to Theupload finalsupporting briefingdocuments. documentIf includingit allis thenot possible to submit these documents listedat belowthe shouldtime beof deliveredrequesting toadvice, MHRAyou nocan lesssend thanthem 10afterwards workingby daysemail. beforeYou themust dateprovide ofdocuments theat meeting.least 3 weeks before a meeting. 

Documents

Briefing document 

You shouldneed submitto 1send electronicthe copyMHRA ofa the briefing document, including:or small number of briefing documents relating to your questions before we can give advice.  

• the

  Briefing finalmaterials proposedshould questionsbe togethercollated withinto youra positionsingle onor eachsmall questionnumber inof Worddocuments. format

• anYou should submit electronic copycopies, ofand include:  

  • any presentation tothat will be given at thea meeting

  • anyscientific appendicesadvice meeting  

  • labelling and leaflet artwork examplesexamples, if the meeting is about changes to labelling and leaflets for a product or range of productsproducts  

  TheTo appendices,provide iffurther relevant,relevant context to your questions, you can include:also upload appendices as part of the briefing documents. Appendices should be limited to essential information only, but can include: 

  • relevant background informationinformation  

  • relevant information relating to theyour questions (eg(for example, relevant study protocols)protocols)  

  • content of

    previous scientific advice received (from the MHRA or other relevant international authorities)authorities 

  • relevant guidelinesguidelines  

  The

  Questions appendicesyou shouldneed beadvice limitedon 

  You need to essentialsend information.the ExtensiveMHRA information,a inlist excess of thatquestions specifiedyou inneed relevantadvice summarieson inbefore thewe Commoncan Technicalgive Document,advice.  

  Your shouldfinal notquestions belist included.

  Weshould willfocus tellon youthe howfuture manydevelopment, papervariation copiesor ofrisk themanagement briefingplan documentfor andyour anymedicinal presentationsproduct. Questions should befocus submitted.on specific scientific issues such as: 

  The meeting

  • MHRAquality staffaspects, willfor haveexample, reviewedchemical, yourpharmaceutical documentationand beforebiological thetesting meetingto andshow willthe eitherquality haveof provisionala advicemedicinal orproduct 

  • non-clinical furtheraspects, questionsfor example, toxicological and clarificationpharmacological fortesting to show the meeting.safety of a medicinal product 

  • Youclinical canaspects, givefor aexample, briefendpoints, presentationtrial butduration, thistarget shouldpopulation, bechoice keptof ascomparator 

  • pharmacovigilance shortplans asand possiblepost-authorisation (usuallysafety onlystudy 10protocols 

  • applications tofor 15variations minutes)or renewals 

  • advice before publishing advertisements for a medicinal product 

  • changes to allowlabelling maximumor timepackaging leaflets for discussion.medicinal Aproducts briefor presentationa ofproduct range 

  Before the issuesmeeting 

  If (andyou perhapshave controversies)requested surroundinga eachmeeting, questionyou maymust besend helpfulyour tobriefing begindocument and final questions list to the discussion.MHRA Onlyat inleast exceptional3 circumstancesweeks shouldbefore anythe informationmeeting date. If you do not indo this, the briefingmeeting documentwill be presented.delayed.  

  TheMHRA meetingstaff will normallyreview lastyour nodocuments moreand thanmay 90contact minutes.

  Youyou shouldwith takeprovisional notesadvice ofor thefurther meeting.questions. 

  AfterAt the meetingmeeting  

  We Successful willmeetings sendoften thestart answerswith toa yourshort questionspresentation within(10 30to working15 daysminutes) ofby the meeting.

  Youperson shouldor sendorganisation usasking yourfor notesadvice. ofThis thepresentation meetingoften withindelivers 15an workingoverview days of the meeting.issues Theseor notescontroversies willsurrounding betheir forquestions.  

  If informationpossible, onlyyou andshould willinclude notthe beinformation commentedcontained on.in Theyour finalpresentation adviceas willpart beof the briefing documents provided into the MHRA advicein letter.advance. 

  Meeting process 

  YouThe canmeeting askmay usbe recorded to clarifyhelp theproduce advicea wewritten give.advice Thisletter, willwhich bewe doneprovide byfor emailsome ortypes teleconference.of Thismeeting clarification(see willthe notTypes coverof themeeting impactsection offor themore adviceinformation on otherwritten aspectsadvice ofprovided yourafter developmentmeetings). planAny orrecordings onwill otherbe developmentfor strategiesMHRA youuse mayonly; considerwe inwill thedelete lightthem ofafter we provide the advicewritten received.scientific advice. 

  SubsequentYou meetingsshould andtake follow-upnotes meetingsduring willthe bemeeting chargedand atprovide them to the sameMHRA rateno aslater thethan initial15 meetingworking (subjectdays toafter the scopemeeting. 

  After of the advice requested).

  meeting  

  TheYou adviceshould providedsend isus withoutyour prejudicemeeting tonotes applicablewithin legislation15 relatingworking todays particularsof andthe documentsmeeting whichtaking shouldplace. beUnless submittedyou inhave supportrequested ofbroader anyscope marketingadvice, authorisationthe (orMHRA other)will application;send ita isscientific alsoadvice withoutletter prejudicewith answers to anyyour intellectualquestions property(see rightsthe toTypes thirdof parties.

  Fees

  Feesmeeting section for scientificmore advice.

  Meetingsinformation requestedon bywritten MHRAadvice orprovided coveredafter bymeetings). agreedWe waivers will notsend bethis charged.

  Youletter willwithin be6 invoicedweeks forof yourthe scientific advice after your meeting.meeting.  

  AsIf ofyou 1need Januaryclarification 2021,on athe waiveradvice fromprovided, scientificyou advicecan feesask isus availableby toemail UKor basedan Smallonline andmeeting.  

  When Medium-Sizedasking Enterprisesfor asclarifications setyou outshould innot expand the Humanscope Medicinesof (Amendmentthe etc.)original (EUadvice Exit)sought Regulationsor 2020.

  Theask MHRAnew Feesquestions Regulationsbased provideson optionthe foradvice ‘smallgiven. companies’If toyou applydo, forthis paymentadditional easement.advice Relevantwill rulesbe refercharged toat ‘smallthe companies’same rate as definedthe byoriginal sectionmeeting. 

  Limitations 382of (3)MHRA ofadvice  

  The theMHRA Companiesworks Acthard 2006to (asprovide amended).useful, accurate and expert advice. 

  PleaseHowever, referthe toadvice Theprovided Medicinesis (productsgiven forwithout Humanprejudice. Use)This (Fees)means Regulationsit 2016

  Howdoes tonot applyoverride forany Smalllaws andabout Mediumthe Companydetails status

  Applicationsand mustdocuments beneeded emailedfor toa sales.invoices@mhra.gov.ukmarketing includingauthorisation a(or copyother) ofapplication. theIt company’s latestalso auditeddoes accounts.not Applicationsaffect forany SMEintellectual statusproperty mustrights bethat madebelong prior to submittingthird anparties. 

  Fees  

  Fees application for a scientific advice.  

  Paying meeting. Iffees 

  When conditionsyour specifiedadvice arefee met,is thenconfirmed itby shouldthe beMHRA, assumedyou thatwill SMEreceive statusa willlink beto approved.pay.  

  TheYou MHRAneed Financeto departmentpay willat assessleast the3 SMEweeks statusbefore applicationyour andmeeting confirmdate, ifor ayour companymeeting meetsmay thebe necessarydelayed. 

  Fee requirements,exemptions andfor soUK-based isSMEs  

  UK-based eligiblesmall toand receivemedium-sized relevantenterprises easements(SMEs) orwith waivers.approved Should SME status bedo approved,not thehave companyto mustpay thenfor submitscientific theadvice. approvalThis letteris fromaccording to the MHRAHuman FinanceMedicines department(Amendment withetc.) their(EU scientificExit) adviceRegulations meeting application.2020. 

  PleaseSMEs refermust toapply Paymentfor easementsSME andstatus waiversfrom forthe SmallMHRA andto Companiesbe –eligible GOV.UK for furtherthis detailsfee waiver. 

  ContactContact  

  scientific_advice@mhra.gov.uk