Guidance on substantial amendments to a clinical trial
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
From 1 January 2021 either the sponsor or the legal representative of a clinical trial must be established in the UK or in a country on an approved country list. This list does include EU/European Economic Area (EEA) countries.
Changing the sponsor or legal representative of a clinical trial
If you need to change the sponsor or legal representative for a UK trial, you must make a submission to both the Medicines and Healthcare products Regulatory Agency (MHRA) and the Research Ethics Committee (REC). This change is a substantial amendment.
Find out more in our guidance.
EU law requires that the sponsor of a clinical trial or a legal representative must be established in the EU. If you need to update your details for an ongoing trial in the EU/EEA then the substantial amendment must be submitted to the EU/EEA competent authorities using your usual method.
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There is no need to submit an amendment to MHRA if:
- the sponsor or legal representative is established in the EU/EEA
- the legal representative for a multi-country study is based in the UK and you are updating details via an amendment to other competent authorities
- the sponsor is established in the UK but a legal representative is added to cover EU/EEA sites via an amendment to other competent authorities.
Investigational medicinal product (IMP) certification and importation
You need to submit a substantial amendment to add or change any IMP manufacturing, importation or certification site relevant for supply of IMP to an ongoing UK trial.
You do not need to submit a substantial amendment if the sponsor retains an existing UK IMP release site for the UK trial and includes an EU/EEA release site for trials in the EU/EEA.
The IMP supply chain from a country on the approved country list will allow direct supply to clinical investigator sites.
If the licence holder needs to be added to a trial
If the holder of a Manufacturer’s Authorisation for IMPs (MIA(IMP)) is required to be included for importation to an ongoing trial, a substantial amendment should be submitted to the MHRA to include the details of the Manufacturer’s Licence (MIA(IMP)) holder performing the ‘supply chain oversight’ role within one year of 1 January 2021.
This means that for up to one year after 1 January 2021, IMPs may be supplied direct from the EU/EEA MIA(IMP) holder to the ongoing Great Britain trial site without the GB MIA (IMP) oversight process.
Amendments relevant to the Research Ethics Committee (REC)
The Health Research Authority (HRA) has produced guidance on when amendments are required to be submitted for REC review.
Northern Ireland Protocol
Guidance on arrangements in Northern Ireland has been published.
Find out more
You can watch a recording of the Clinical Trials webinar which took place on 21 October 2020.
Contact
For further information, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. You can also email clintrialhelpline@mhra.gov.uk with urgent questions. Alternatively, contact your Trade Association by emailing:
- Association of the British Pharmaceutical Industry (ABPI): regulatory@abpi.org.uk
- British Generic Manufacturers Association (BGMA): info@britishgenerics.co.uk
- BioIndustry Association (BIA): regulatory@bioindustry.org
- Clinical & Contract Research Association (CCRA): mail@ccra.org.uk
- Ethical Medicines Industry Group (EMIG): info@emig.org.uk
- Health Food Manufacturers’ Association (HFMA): pennyviner@btconnect.com
- The National Pharmacy Association (NPA): independentsvoice@npa.co.uk
- Proprietary Association of Great Britain (PAGB): regulatory@pagb.co.uk