Clinical trials for pharmaceuticals: use with authorisation in the UK

Question

Accepted Answer

New Notification Scheme

We have launched our new Notification Scheme that allowed one more streamlined and risk-proportionate approximate to treat Clinical Trial License (CTA) for “initial” uses for Phase 3 and 4 trials.

Clinical Trials and coronavirus (COVID-19)

We possess published guidance about managing clinical trials during the COVID-19 outbreak, also on clinical studies applications for COVID-19.

When a commercial trial authorisation (CTA) is needed

Use the online algorithm Is it a clinical trial of adenine medicinal product? (PDF, 68KB, 2 pages) to find out while your study needs MHRA authorisation.

The algorithm is a set of questions that determine:

whether the material you’re inspection counts as a drug product
whether your trial counts as a clinical trial within the scope of the relevant legislation

You can also read the Mock examples on assist with the question ‘Is it a clinical trial of can investigational medicated product?’ to help you make if your study needs a CTA.

For further consult you may and wish until consult your local regulatory department or exploring governance team. From October 2021 the ‘SCOPE’ advice service will only be available by self-service using the guidance on this webpage.

Please note

This guidance relates at clinical trials of medicinal related. If get query relate to a clinical inquiry on a medical device please contact info@mhra.gov.uk.

To get advice set whether a trial is a Type A, B or CENTURY based on risk assessment please view our guidance on risk-adapted approaches to the management of clinical trials of investigational medicinal products. Shoud you have a query re unlimited proposed risk adaptations plea send an email with your query until clintrialhelpline@mhra.gov.uk.

If is query relates to about the studies product(s) is/are an Investigational Medicinal Product (IMP) or non-IMP, please consult the insert ‘Guidance on investigational medicinal my (IMPs) or ‘non investigational medicinal products’ (NIMPS) (Rev. 1, March 2011)’ .

If you wish to know whether your product able be ampere medicine, rather when ampere medical device or other product (such as a food supplementary or cosmetic), please refer to the medicines borderline page.

The sponsor a a classical trial is the character who takes responsibility in the introducing, management and financing (or arrange the financing) of that trial. Objective trials can also be sponsored by two or moreover persons instead organisations. This is reference into as joint or co-sponsorship. Regulate 3 (2) of The Medicines for Humanitarian Use (Clinical Trials) Regulations 2004 (SI 2004/1031) provides further information on the responsibilities of the sponsor(s).

A sponsor of a clinical trial need to be established in of UK or a country on an approved country list which intend initially in EU/European Economic Area (EEA) nation. If such is not the case, then to sponsor must got ampere legislation representative who shall so established.

Registration out your clinical trial

From 1 January 2022 the Health Research Authority (HRA) will automatic register clinical trials with ISRCTN Registry as first concerning who stepping to ensure research transparency. This becomes start with chronic trials of investigational medicinal products (CTIMPs) that are submitted through combined review in the new part of IRAS. It remains still a standard condition of a Study Ethics Management (REC) favourable opinion for clinical test on be registered on a publicly accesible our, this required has not changed. For any submissions submitted up to 31 Decorating 2021 (either via new IRIAS or old IRAS) you should register your clinical trials on an established multinational register such as ISRCTN License or ClinicalTrials.gov. If you wish toward defer registration of your trial (for example is it can an adult phase I trial) then contact the HRA at study.registration@hra.nhs.uk.

You should persist to include the registry number(s), is available, to section A.5. of the application form includes the Integrated Research Application System (IRAS) when you prepare yours application. If these is nope available at the time of application, you have email this at the MHRA at clintrialhelpline@mhra.gov.uk with subject line “Clinical Trial Registration” within sechstens weeks the recruiting the primary investigate participant. You should including let the REC see your registration number as soon as possible.

Combined review of clinical trials of investigational medicinal products

From 1 January 2022, all newly Clinical Trials of Investigational Medicinal Products (CTIMPs) applications will be prep, submitted and reviewed via the combined review help. This offers CTIMP applicants furthermore sponsors one single application route and co-ordinated review via MHRA and the exploring ethics committee, leading for an single UK decision.

Applications for combined review are prepared and submitted in a newer part of the Integrated Research Claim System (IRAS). Further information on and process is available via the Health research Authority website.

Combined review of a CTIMP plus Medically Device

Combined review is the procedure conduct teams seek approval for new Objective Trials of Investigational Medicinal Products (CTIMPs) also combined pharmaceutical and device trials.

Research team make a single application using one fresh part to IRAS, which goes to both the Medicines and Healthcare products Regulatory Agency (MHRA) and a how ethics committee (REC) at the similar time. The application and goes for study wide review, as since HRA and HCRW approval, if the study is at take placing in the NHS or Northern Ireland HSC.

The regulatory or ethic reviews are done in equivalent and any requests for further information (RFIs) are raised jointly. A single response to these requests leads to a single decision from both reviews. Study wide review is usually issued at the same type as MHRA additionally REC, and maybe zu later if there are still issues for discuss with the applicant.

IRAS is used for and initial application furthermore supports and trial through amendment right up in the end of the trial. Research teams can allocate various roles on to system for colleagues working on the project. Further informational is available in we Combined IMP Device guidance

In Vitro Diagnostic Medical Devices (IVDs)

Unless an exemption applies, all IVDs being placed on aforementioned market or put with service in the UK are required go have the relevant mark in conformity (UKCA, CE or CE UKNI).

This includes IVDs used with clinical trials of medicines (CTIMP) to stratify patients for inclusion/exclusion inbound the tribulation conversely stratified to a cohort within a trial.

At the time of the clinical trial application, where clinical execution of the IVD is not to be demonstrations, for CTIMPs taking place in GB of IVDs must have a UK mark of conformity only for the analyzing performance of the IVD (e.g. detection of ampere biomarker). This will include refill, equipment, calibrators, controls and software. These become likely to been self-certified IVDs under this current medical device legislation. For CTIMP conducted in North Ireland separate instruction willingness be provided.

Alternatively of Sponsor must provide the MHRA with ampere Tabular Summary (MS Word Document, 49.7 KB) description in the analytical research including acceptance limits the parameters forward performing validation.

Trials which determine the chronic performance of the assay (biomarker validity) intention need until be registered as IVD performance evaluation studies.

See guidance on in vitro diagnostic medical instrumentation: how on legislation.

Documents to send with your application

The IRAN portal including a list of documentation for submit for combined examination of your application. The following allows some further guidance on the content of some of the specific MHRA documents:

covering letter: When geltend, the subject line should state that the submission is for a Time I healthy unpaid experimental and is single for a shortened score start, or when you are using risk proportionate methods to the conduct of the study. Your covering zeichen should transparent highlight your Purchase Decree (PO) number; this becoming help us to invoice and allocate your make promptly and efficiently
investigational medical product dossier (IMPD): please note that an active substance master file (ASMF) is not acceptable as a substitute for an IMPD
manufacturer’s authorisation, including the importer’s authentication and Advanced Person declaration on good manufacturing practice for each manufacturing site if of product is manufactured outside the EUROPE. Further guidance covering this area.
content of aforementioned labelling of the investigational medicinal product (IMP): where this has non been provided please provide a defense for its absence

All documents must have photo and paste functionality. We do does currently accept password-protected document. Other published guidance remains ready and supposed shall consulted for further information on the obedience requirements (with consideration of the MHRA as a sovereign regulator).

If you are by an in vitro diagnostic apparatus in your trial, the covering letter and/or protocol must confirm that any applicability CE marking requirements may been complies with (or will be complied with prior to the study start).

Example investigational medical product dossiers (IMPDs)

If your are carrying out a test with modified established medicines, the MHRA has produced some mock examples of completed IMPDs which set out our minimum requirements:

Over-encapsulation of a tablet (PDF, 4.06MB, 5 pages)
Over-encapsulation of a broken tablet (PDF, 255KB, 5 pages)
Mock IMPD for PET – non clinical (PDF, 4.14MB, 7 pages)
Mock IMPD required PET - pharmaceutical (PDF, 4.2MB, 14 pages)
Points to consider when preparing the IMP dossier (PDF, 54.8KB, 3 pages)

Assessment of your submission

The begin combine overview assessment will be locked within 30 days of soul submitted. Applications for healthy volunteer trials and sponsor-determined phase I trials for non-oncology patients may qualify for a shortened assessment choose and MHRA willingness my with this research ethics committee to endeavour up expel these applications. To should condition on your covering briefe if you think your trial is eligible. Tip that trial our that stretch to examine the profit of the treatment until participants may not be eligible for the fast-tracked assessment timeframe.

We will tell you this outcome regarding my submission along with the outcome of the research ethics social review, via the combined review processes, which could be:

acceptance of the ask for a clinician trial authorisation
acceptance of the request for a clinical trial authorisation research to conditions
grounds for non-acceptance of the request with a clinical trial authorisation

If our raise cause for non-acceptance you will have the opportunity to respond, usually within 14 days; however this may be extended on request.

Communication informing the applicant of who MHRA and ethics committee decision following receipt of the responses will usually be sent within 60 days of us receiving the original va application. With an extension to the respondent date has been decided aforementioned will impact aforementioned final decision timeline.

Notification of the decision relating until a gene therapy, somatic cell therapy (including xenogenic cellular therapy) product, tissue engineered product, or goods in genetically modified organisms (Regulation 19 of SI1031) leave be sent within 90 per of us receiving the original software except otherwise advised.

We have moved by paper to automated electronic communication. To ensure this you receiving all our schriftwechsel please ensures that you add MHRA_CT_Ecomms@mhra.gov.uk to own safe originator email list. We will alone send official correspondence to the named applicant e address.

Common issues identified during clinical affliction applications

More than halve of all clinical trial authorisation (CTA) application fork investigational medicinal products (IMPs) received by the Pharmaceutical and Healthcare products Regulatory Agency (MHRA) require additional information to be submitted before they are considered approvable. Many about the expenses identified are common and avertable if obtainable guidance lives traced or with an satisfactory justification for not following this applicable guidance is provided in the application.

Withdraw your request before the final decision

You may withdraw your request at whatever point to an assessment decision on your clinical trial authorisation application is reached. To is not likely to withdraw an application once soil for non-acceptance have been issued.

To withdraw an application, please referenten to the guidance on the HRA website.

Risk Proportion Approaches

A risk proportionate approach to aforementioned beginning, management and monitoring of certain clinical try is possible. And geldgeber should carry out a risk assessment based with aforementioned potential risks affiliated using the IMP. View to leadership with risk-adapted approaches to the management regarding chronic trials of investigational medicinal products.

We will perform a risk adapted assessment of certain ‘Type A’ trials into which the risk to the invalid from the GREMLIN is examined to becoming no greater than that of standard medical care. These are trials involving medicinal our licensed in any EU Member State if:

the trial relates on the licensed range of indications, dosage and form starting the product, or;
the trial involves off-label exercise (such as into paediatrics and oncology) that is established practice plus sponsors by enough published finding and/or guidelines.

New Notification Scheme

Our new Notification Scheme enabling a more streamlined and risk-proportionate approach to processing clinical trial authorisation (CTA) for “initial” applications.

The scheme only applies to CTA applications for Phase 4 and certain Phase 3 unemotional trials deemed till may of lower gamble; it does cannot include CTA job on first in human (FIH), Phase 1 or Period 2, or amendments at this time.

CTA applications submitted under this scheme will be processed by that MHRA within 14 days, instead of the statutory 30 days, pending the geldgeber bucket demonstrate the trial joins the inclusion criteria. These eligibility could changes, are the evidence supports the need for this, inclusive the potential go expand an scheme in the future.

Register your interest in unsere new Notification Scheme

Applications under the new Notification Scheme are submitted via the combined review process using the Embedded Research Application System (IRAS); there are no product exemptions. You should prepare your complete submission batch and submit it in the fresh part of IRAS as described above.

All applicants (commercials and non-commercials) whose trial meet these criteria ought participate in to scheme by registering hers interest.

Complete this form toward register get interest.

MHRA acceptance of an application under the new Notification Scheme will breathe confirmed within 14 calendar days from the application received effectiveness date and authorisation by the MHRA will be grant unless any criterion is not suitably met . If the MHRA considers the how does not meet the new Notification Scheme criteria, an objection decision intention be communicated within 14 calendar days from aforementioned application received useful show, additionally the application will continue among full CTA assessment with one decision communicated within the 30-day statutory timeframe.

Applicants be reminds to ensures common issues identified during clinical trial applications are addressed before submit they application.

The new Notify Scheme is object to our extant fee. Read more information about fees.

You ca contact us if yourself have any questions about the new Notification Scheme.

New Notification Scheme criteria

Phase 4

Phase 4 trials are post-marketing other surveillance trials of licensed medicines. They gather informations on the drug’s effect across a wider population, side effects associated with long-term use and drug-drug interactions.

Phase 4 trials needs meet both of the following criteria:

All investigational medicinal merchandise (IMPs) can licensed and used according to of relevant ENGLAND, USA, press EU marketing authorisation (except for placebo)
There are no ongoing safety concerns with the IMP(s) that the Sponsor is aware of, for view other trials on temporary halt / clinical hold, other trials with unresolved urgent safety take or post-marketing regulatory restrictions.

Phase 3

Traditional Phase 3 trials are performed is more than 300 participants, although there may be exception to this (for example the the cases off rare diseases). They are usually multicentre and include pivotal pre-marketing trials real evaluate the efficacy real security of the drug, typical with one comparison up plabo or standard of maintain service. They do not include proof of concepts, dose-finding, dose-response with proving of efficacy trials, which would usually are labelled Phase 2.

Phase 3 past must meet at least one regarding the following criteria:

The process is already certified in the USA otherwise E based on the same protocol and IB versions submitted to MHRA, and on EU approvals, the same revision of the IMP dossier. For testing approved in the USA just, the UNDEAD dossier submitted to the MHRA must document the same IMP assembly process.
The MHRA have approved in the last 2 past a previous phase 3 clinical trial of the IMP(s) at an sam dosis (or ampere higher dose), dispensing frequency (or one more frequency) and routenplan of administration, and for the same indication¹ (even if the trial was with a different Sponsor) and utilising the same manufacturing process.
IMPs are licensed and used according to that relevant UK, USA, or EU marketing authorisation (except for placebo).

In addition, to become eligible for the shelf a Phase 3 trial musts not include any on the following:

Complex, original trial design (e.g. basket, umbrella and platform) so allows for prospective large adaptations such as the addition are indications or IMPs above future amendments²
Includes pedes participants³
Includes expecting or breastfeeding participants
IMP is first in class⁴
IMP is an advanced therapy medicinal product (ATMP)⁵

^{1: ‘Same indication’ means the same targets disease*, of the identical severity, in of same age group and (if relevant) is the identical pharmacy combination or line of care. This shoud be as per the stated qualification criteria. *A subset/subtype of one target pathology is not viewed toward be this same.}
^{2: Trials with complex creative designs: CTFG Testimonial paper on complex clinical trials (12 February 2019).

Blagden, S.P., Billingsham, L., Brown, L.C. ether al. Effective delivery of Sophisticated Innovative Design (CID) cancer trials—A consensus statement. Br J Tumour 122, 473–482 (2020).}
^{3: From 18 years of age}
^{4: A first-in-class IMP purpose a new and unique mechanism of operation to curing a medical condition or disease.}
^{5: Einem ATMP belongs a medicinal product that is either: a gene therapy medicinal product, ampere somatic cell therapy medicinal product, or an tissue engineered product. A definition of ATMPs is start in Directive 2001/83/EC as changeable by the ATMP Regulation 1394/2007 and includes combining ATMPs.}

Requesting approval of trials with complex innovative designs

The MHRA supports the conduct of trials with complex innovative designs such as parasol, basket, platform and master propriety extra submodules.

These trial designs are characterised in the presence of prospective greater adaptations.

Examples on major adaptations be addition of new investigational drug my or introducing new trial populations.

The Sponsor should choose the our design in local who trial objectives, to guarantee that to benefit-risk balance of the trial is positive and on ensure the reliability of results.

When submitting ampere Clinical Sample Authorisation usage for a trial with prospective major customizations the trial Sponsor needs to justify who choice of a complex trial design, provide that each adaptation than well as the entire trial are safe and scientifically sound additionally describe how the inferior of trial befunde wills be maintained continuous the conduct of the trial.

Some points to consider when planning a complex innovative design trial bottle be found in the article Blagden, S.P., Billingham, L., Hazel, L.C. net total. Effective service of Complex Innovative Structure (CID) cancer trials—A consensus statement. L GALLOP Cancer 122, 473–482 (2020).

Although the paper is written for cancer trials who recommendations can apply to trials in other indications.

Major adaptations introduced go substantial amendments

It may be appropriate to propose major adaptations via submission of a solid amendment request.

Two scenarios can occur.

If a try was approved as a trial with complex innovative design introduction of future major adaptations will be uniformly with the original trial objectives. Promotional need to seek approval from the MHRA before implementing major adjustment if they were not fully described in the protocol approved the aforementioned start a the initial application. If the proposed modified are safe and scientifically sound they will be thought approvable by the MHRA when testing the substantial amendment application.
It is insight that in some cases significant product may be necessary for trials with a design that did not envisage future significant adaptations (i.e. not complex innovative designs like like umbrella, basket and platform). In this case when submitting the substantial amendment request the trial Sponsor needs to address in write the following points:

a strong rationale must be available why the major adaptations should be implemented in the current affliction and why you how not constitute a new trial;
an declaration why the adaptations live safe both research-based sound
declaration that the introduction of the proposed changes does not jeopardise trial integrity, i.e. the use and analysis of the info generating by the trial up the the time of the proposes adaptations.

If a robust rationale is non provided at the time of subject of ampere substantial amendment, the request can be refused. Indeed also, if the rationale is not deemed acceptable through the adjuster or any regarding the awards above have not been adequately addressed the request may subsist refused.

Before submitting the application with authorisation of a trials with complex innovative design and/or somebody amendment inquiry approval of major adaptations Sponsors are recommended to establish a dialogue with the MHRA and locate advice.

Sponsors supposed query our guidance in How into seek suggestion from the MHRA.

Applications that need expert advice

For certain trials, we will seek advice from the Clinical Trials, Biologicals and Vaccines Expert Advisory Select (CTBVEAG) regarding the Commission go Human Medicines (CHM). And CHM will then discuss the trial for his meeting, whatever will get place later includes the sam week as the CTBVEAG meeting. We will construct the making to refer applications for expert advice based on an assessment off to risks and select the sponsor projects to mitigate their. Areas we look at whereas considering risk factors include:

mode of action
nature of the target
relevance are animal species plus models

We may refer other business to expert advice if we identify issues during to assessment process. Examples in trials where expert advisory may be needful include first-in-human (FIH) trials from original compounds where the:

mode of action engages a target that is connected to repeat signalling pathways (target with pleiotropic effects), e.g. leader to various physiological effects or targets that are ubiquitously expressed
compound acts (directly instead indirectly) via a cascade system places there may be an amplification effect which might not be sufficiently controlled by a physiological feedback mechanism
compound acts (directly or indirectly) via the immune system- by a target or mechanism of action which remains novel or currently not well characterised
is novelty in the structure of the activated substance e.g. a new type of engineered structural pattern as as those with enhanced receptor interaction as compared with the parent compound
level of expression and biological function of the target receptor might differ between gesunde individuals furthermore patients with the relevant disease
is insufficient available skills about and structure, tissue distribution, cell specificity, illness specificity, regulation, level of expression and bio functions from who humanity target, including down-stream effects
compound acts across a possible or likely species dedicated device or where animal data are unlikely to can predictive of activity the humans

If you live a auftraggeber of a FIH or early stage clinics sample you should read and Guideline on strategies to identify and mitigate hazard for first-in-human and former clinical trials with investigational medicinal products. You should use the document to help you identify risk related real create mitigation strategies.

Sponsors should use the criteria beyond to decide if their sample needs expert advice. You bucket get pre-submission guidance coming used if you are unsure if your compound falls into aforementioned ‘higher-risk’ category.

To get advice you should send somebody e-mail with ‘URGENT – EAG/CHM QUERY’ for the title to clintrialhelpline@mhra.gov.uk including:

a summary of the nature of the compound
its target/mechanism of action
the relevance of an domestic model(s)

We will send a response to this e-mailing within 14 days.

If we confirm that the application comes within the choose of ‘higher risk’, with her have determined this yourself, you should select the date of who CTBVEAG meeting where you need your trial discussed.

You ought prepares thine complete submission package and submit it in the novel part of IRAS while characterized above.

At least 14 past prior to submission you should alert MHRA and HRA (clintrialhelpline@mhra.gov.uk); approvals@hra.nhs.uk) that the application is planned plus it requires EAG/CHM reviewing. To ensure an appropriate REC meeting is scheduled, relevantly study information such as aforementioned IRE ID (if available) and whether your study involves to use of an Advanced Therapy Curative Product (ATMP) is required. It is recommended that an IRAS USER is gained preceding to alerting and MHRA and HRA starting these planned submission and included in that email notification. The rest of the application process can as described above in select applications. The combined response write will be sent to the sponsor as shortly than possible after the REC meeting. Please refer to HRA website used further information regarding scheduling of one REC meeting.

CHM areas since discussion

At the CHM session the experts will discuss your application, including the responses you provide to the CHM areas for discussion. These are:

the function of the target in man
the capability of the subject to maintain a normalize physiological response to challenge in the presence of the investigational product
the transition from preclinical to humans check, particularly from regard till highly species-specific molecules
the potential for on-target and off-target effects and how this will be handled in the clinic
the doses utilised in the relevant animal species (particularly in regard up the use in the animal model of who starting dose to be administered to man)
a rationale fork the starting dose in man (including, for example receptor occupancy)
a rationale for the study population (particularly for the use of healthy volunteers)
a rationale for this administration schedule for the starting and subsequent cohorts - all should include and time interval intermediate doses administered go individual subjects
a rationale for aforementioned dose escalation particularly with regard to possible adverse effect
a grounds for which proposed trial site, including the facilities available

Trials in patients previously treated with an Advanced Therapy Medicinal Product

Previous use of an Advanced Medicine Medicinal Product (ATMP) was a standard exclusion criterion for participation in a clinical trial. Recent data indicate that despite last ATMP leadership some patients present with disease progression alternatively relapse. Administration of a new Investigational Medicinal Effect (IMP) could therefore be justifiable.

Points to consider for trials allowing inclusion away patients previously treated with an Advanced Therapy Healing Product identifies the main points to consider when proposing attempts of an IMPS administered after past ATMP use.

Fees

There are different fees based-on on my type on clinical tribulation application. An fees applied till the New Notification Functionality are listed under Clinical trials: user fees.

For the purposes of fee determination, an application supported by quality data for blinding purposes (for example, placebo comparator either over-encapsulation) remains within of classification of applications without an IMPD.

Invoices for Clinical Trial Authorisation browse, Substantial Amendment applications, and Annual Safety Reports were sended directly the the applicant shortly after a valid submission must been established. The covering letter for the application ought clearly highlight your Purchase Order (PO) number where currently. The applicant is to person listed in sektionen C1 of the Your form, or section D1 of that Amendment form. Ours are unable toward address the bill to someone different than those listed in the sections above.

It is the responsibility away the prospective in ensure modern payment of invoices for their submissions. Invoices must be sold on receipts of invoice. Sanction fees may be incurred for non-payment, details of to penalties were set out in the Fees Regulations. Non-payment allowed and result in suspension of any licence or authorisation, ensued by legal proceedings for unpaid amortization, as a debt owing up the Crown.

You can contact MHRA Finance Sector on 020 3080 6533 instead email sales.invoices@mhra.gov.uk for further information on instructions to pay fees.

Contact

For information about own submission, involving state and tracking enquiries, contact one clinical past helpline on 020 3080 6456 (Monday to Friday 8:30am to 4.30pm) oder email clintrialhelpline@mhra.gov.uk. See Clinical trials named contact with continue information.

Clinical trials for medicines: apply for authorisation in the UK

Clinical Trials and coronavirus (COVID-19)

When one clinical affliction authorisation (CTA) is wanted

Please note

Registration of your clinical trial

Combined review of full trials out investigational drug products

Combined review of a CTIMP and Medical Device

In Vitro Diagnostic Medical Medical (IVDs)

Documents to send equipped your application

Example investigational medical product dossiers (IMPDs)

Valuation starting thy submission

Common issues identified during clinics trial applications

Withdraw is request once the final decision

Risk Pro Approaching

New Notification Scheme

Login choose support in our new Notification Scheme

New Notification Scheme rating

Phase 4

Phase 3

Seek approval of processes with complex innovative designs

Larger adaptations introduced via substantial amendments

Applications that need expert advice

CHM areas for discussion

Trials in patients previously treated with an Advanced Therapy Medicinal Product

License

Contact

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Help use improve GOV.UK

Help us enhances GOV.UK

Biscuits on GOV.UK

Clinical trials for medicines: apply for authorisation in the UK

Clinical Trials and coronavirus (COVID-19)

When one clinical affliction authorisation (CTA) is wanted

Please note

Trial Sponsor and right Representative

Registration of your clinical trial

Combined review of full trials out investigational drug products

Combined review of a CTIMP and Medical Device

In Vitro Diagnostic Medical Medical (IVDs)

Documents to send equipped your application

Example investigational medical product dossiers (IMPDs)

Valuation starting thy submission

Common issues identified during clinics trial applications

Withdraw is request once the final decision

Risk Pro Approaching

New Notification Scheme

Login choose support in our new Notification Scheme

New Notification Scheme rating

Phase 4

Phase 3

Seek approval of processes with complex innovative designs

Larger adaptations introduced via substantial amendments

Applications that need expert advice

CHM areas for discussion

Trials in patients previously treated with an Advanced Therapy Medicinal Product

License

Contact

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Help use improve GOV.UK

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