Additionally, per GAfREC , EC members receive no payment for contributing to the application review process at scheduled meetings or for attending these meetings.
A head office represents each of the health departments within the four 4 UK nations and serves as the appointing authority for the recognized ECs. The official RES head offices i. This group works together across the four 4 nations of the UK, and provides a coordinated research approvals system and consistent policy and good practice standards. See GBR for upcoming meeting dates.
According to the G-CTApp , the clinical trial sponsor takes responsibility for the initiation, management, and financing or arranging the financing of that trial. Clinical trials can also be sponsored by two 2 or more persons or organizations, which is referred to as joint or co-sponsorship. In all cases, evidence should be provided with the application that the legal representative is willing to take on that role and is established at an address in the UK or a country on the approved country list.
For example, a copy of correspondence between the sponsor and legal representative on appropriately headed paper could be supplied, or a copy of a contract. Where the legal representative is also a co-sponsor, this should be separately recorded on the application form and details given of the allocation of sponsorship responsibilities. Evidence of insurance or indemnity cover should be provided.
Further, no amendment will need to be submitted in the UK if the sponsor retains the UK legal representative for the UK study.
Note that per GBR-9 , in the case of international studies, an application must be made to an EC in the UK, whether or not the study has a favorable ethical opinion from a committee outside the UK and whether or not it has started outside the UK.
See Clinical Trial Lifecycle topic, Submission Content subtopic for detailed submission content requirements. Per the GBR , the clinical trial application will be validated on receipt and an acknowledgement letter will be sent to the person submitting the application. If the application is valid, then the assessment period will begin. This starts from the date of receipt of a valid application. If the application is not valid, then the applicant will be told of the deficiencies.
Nothing will happen to the application until the missing components are provided. To express an interest, email cwow hra. All documents must have copy and paste functionality. MHRA does not currently accept password-protected documents.
The information in the submission package will be used to validate the application and incomplete applications will be rejected. In addition, the naming of files is important and clearly naming files will reduce validation issues. See Clinical Trial Lifecycle topic, Submission Content subtopic for documentation to be included in the application package.
See the Ethics Committee topic for detailed coverage of EC operations and responsibilities. MHRA Requirements. Per the G-PIPs , UK marketing authorization holders who sponsor a study that involves the use of the authorized medicinal product in the pediatric population, must submit to the MHRA results of the study within six 6 months after the trial ended. EC Requirements. EC reviews are booked through the Online Booking Services and will be booked in the first available slot for an EC that is suitable for the type of study.
ECs are geographically located across the UK. Applicants are strongly encouraged to attend meetings in person. Some studies must be reviewed by an EC that is flagged for the type of research to take place. Refer to GBR for detailed submission and booking instructions.
Clinical Protocol. According to GBR , the clinical protocol should contain the following elements:. For complete protocol requirements, refer to GBR MHRA Approval. Clinical Trial Application Submission. For Phase I trials, the average is 14 days. Additionally, responses for Phase I healthy volunteer studies will be reviewed within an average of 14 days, and studies using gene therapy, somatic cell therapy including xenogenic cell therapy products or products containing genetically modified organisms will be reviewed within 90 days or receipt of the original application.
This includes trials involving medicinal products licensed in any European Union EU Member State that meet the following criteria:. Type A trials include studies in which the potential risk associated with an investigational medicinal product is determined to be no higher than that of standard medical care. If the MHRA raises objections, the submission is treated as a standard request for authorization. Ethics Committee Approval.
When an EC requires further information before confirming its opinion, it may give a provisional opinion, and it is permitted to make one 1 written request for further information, clarification, or changes to documentation.
The time it takes for the EC to receive a complete response to the request does not count against the day timeline. Studies using gene therapy, somatic cell therapy including xenogenic cell therapy products or products containing genetically modified organisms will take 90 days, or days if a specialist group or committee is consulted.
Per GBR-9 , the ethical review includes an assessment of the suitability of each site or sites at which the research is to be conducted in the United Kingdom UK. In rare cases when this is not required, adequate arrangements must be in place for supervision of the study in the UK.
As stated in the MHCTR , all investigators must possess appropriate qualifications, training, and experience. These model agreements replace the versions. See GBR for the notes that provide further background, an overview of the changes from the versions, and more information on how and under which circumstances the templates should be used. While the versions of these templates will still be accepted in IRAS GBR , applicants are encouraged to adopt the versions at their earliest opportunity.
Applicants are advised to use the templates without modification. Any proposed modifications will not be accepted unless first agreed to by the UK Contracting Leads. Proposing modifications to the templates is likely to result in significant delay. Feedback on the content of the templates and their use by sponsors should be provided to mCTA hra.
This agreement has been developed as a single, UK-wide agreement template, meaning that it can be used irrespective of where the sponsor and research site are established. It is designed to be used without modification or negotiation. The mNCA has been developed for a range of interventional research scenarios, including clinical trials, medical device studies, research using patient data, and research using human tissue. The terms and conditions are suitable for all such scenarios and only the completion of highlighted sections, including the schedules of the agreement, will differ depending on the study involved.
It is also acceptable for the letter to be signed by a vice-chair or a member of the staff supporting the EC acting under delegated authority from the Chair.
The letter is emailed to the applicant within the relevant time limit for review of the application. These amendments may not be implemented without a favorable opinion from the EC. As per the G-CTReg and GBR , the sponsor or investigator is required to register the clinical trial in a publicly accessible database as a condition of a favorable ethical opinion.
Registration should occur before the first participant is recruited and no later than six 6 weeks after recruitment of the first participant. In the long term, the HRA has made a commitment to register clinical trials on behalf of sponsors and researchers in its Make It Public research transparency strategy.
If trial registration is deferred for example if it is an adult phase I trial , then contact the HRA at study. The registry number s , if available, should continue to be used in section A. If this number is not available at the time of application, email the MHRA at clintrialhelpline mhra.
The applicant should also let the EC know the registration number as soon as possible. If sponsors wish to harmonize the implementation date of an RSI in a trial that includes European Union EU and UK sites, then they can use the date when approval is granted in all member states and the UK.
The report may be made orally or in writing, and followed by a detailed report no later than 24 hours after the event. Per GBR-1 , the investigator and the sponsor share responsibility for the assessment and evaluation of adverse events with regard to seriousness, causality, and expectedness. Any additional relevant information should be sent within eight 8 days of the initial report.
The sponsor must also report any non-fatal or non-life-threatening SUSARs no later than 15 calendar days following first awareness of the event. The DSUR should include:. Phase 4 national UK only trials of licensed products, which commanded a low fee from the MHRA, and where all participants have completed treatment and are only in the follow-up stage will also be suitable for submission of a short format DSUR.
Per GBR , a sponsor or investigator may take appropriate urgent safety measures USMs to protect research participants against any immediate hazard to their health or safety, without prior authorization from a regulatory body. The main EC, and the MHRA for clinical trials for investigational medicinal products CTIMPs , must be notified immediately no later than within three 3 days in the form of a substantial amendment that such measures have been taken and the reasons why.
If key details are not available during the initial call, then the sponsor should inform MHRA no later than three 3 days from the date the measures are taken by email to clintrialhelpline mhra. Written notification in the form of a substantial amendment is also required. The substantial amendment covering the changes made as part of the USM is anticipated within approximately two 2 weeks of notification to the MHRA.
Any potential reason for delay of substantial amendment submission should be discussed and agreed upon with the MHRA at the time of initial notification or through a follow-up call. Submission of the substantial amendment must not be delayed by additional changes outside of those taken and required as an urgent safety measure. Unrelated and unacceptable changes may result in rejection. The International Council for Harmonisation's Guideline for Good Clinical Practice E6 R2 GBR recommends establishing a DMC to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.
In accordance with GBR and GBR-9 , the chief investigator CI is responsible for submitting progress reports annually, or more frequently if requested by the ethics committee EC , on the status of a clinical trial.
Per GBR , a progress report should be submitted to the EC 12 months after the date on which the favorable opinion was given. Progress reports are only required for studies that are more than two 2 years in duration and for Research Tissue Bank and Research Databases.
There is no requirement to submit a progress report for proportionate review studies and where the study is two 2 years or less in duration. An electronic copy should be emailed to the EC within 30 days of the end of the reporting period. The G-CTAuth further specifies that a declaration of the end of a clinical trial should be sent to the MHRA within 90 days of the global end of the trial and within 15 days of the global premature end of the trial.
Note that only the global end-of-trial notification is required to be submitted. However, a facility may inform MHRA of the local UK end of trial via the end-of-trial notification form, but these local notifications will not be officially acknowledged and the MHRA Submissions automatic email confirmation should be considered as evidence of submission.
If a local end of trial is submitted, we would still expect to receive relevant safety updates and substantial amendments for the ongoing trial until the global end of trial notification is received. An exemption to this requirement must be requested via a substantial amendment for approval.
The amendment must clearly state to what documents the proposal relates and provide a robust rationale for the request. All safety documentation must be submitted unless there are no other trials ongoing with the same product in the UK.
Any trial activities such as follow-ups, visits must be completed before the submission of the global end-of-trial declaration form. If the end-of-trial declaration has been received within a reporting period, or within 60 days following the data lock point, the corresponding DSUR will not be required. Sponsors should publish summary results within this timeframe in the public register s where they registered the clinical trial. While it is not required to submit this clinical trial summary report to the MHRA, sponsors must send a short confirmation email to CT.
Submission mhra. An acknowledgement letter will not be sent for this submission. There is no standard format for final reports. However, the minimum information to be provided to the EC should include whether the trial achieved its objectives, the main findings, and arrangements for publication or dissemination of research.
The sponsor must ensure that the trial design meets appropriate standards, and arrange for the trial to be properly conducted and reported. In addition, per GBR , the sponsor is the individual, organization, or partnership that takes on overall responsibility for proportionate, effective arrangements being in place to set up, run, and report a research project.
Any trial-related responsibilities transferred to a CRO should be specified in a written agreement. The CRO should implement quality assurance and quality control. If this is not the case, then the sponsor must have a legal representative who is so established. The legal representative:. When this applies, the MHCTR requires one 1 of the parties to submit the clinical trial application for authorization to the Medicines and Healthcare Products Regulatory Agency MHRA , and to specify who is responsible for carrying out the following functions:.
A change in sponsor or legal representative for a UK trial is a substantial amendment requiring submission to both the MHRA and the ethics committee.
GBR-7 provides guidance on key data protection requirements to consider in the post-Brexit environment. Among other things, it describes how data can continue to flow to and from the UK, as well as controller responsibilities. IRAS enables researchers to enter the information required by all UK review bodies only once, rather than having to complete several separate application forms to obtain these permissions and approvals.
See the Clinical Trial Lifecycle topic , Submission Content subtopic for documentation to be included in the application package.
As set forth in the MHCTR and the MHCTR , it is a legal requirement for an insurance and indemnity provision to be made to cover the liability of the investigator and sponsor for trial related injuries. See GBR for detailed information on the NHS indemnity responsibilities for clinical negligence involving investigators and participants. See the Sponsorship topic , Compensation subtopic and Informed Consent topic , Compensation Disclosure subtopic for specific details related to sponsorship compensation obligations.
The investigator, in turn, communicates this information to the relevant ethics committees ECs. The International Council for Harmonisation's Guideline for Good Clinical Practice E6 R2 GBR also provides guidance for sponsors on providing compensation to research participants in the event of trial-related injuries or death. See the Informed Consent topic, Compensation Disclosure subtopic for additional information.
QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed. A serious breach is defined as one that is likely to effect to a significant degree: the safety or physical or mental integrity of the trial participants; or the scientific value of the trial. Further, the sponsor should investigate and take action simultaneously after the MHRA notification.
Notifications should primarily be sent to the following email address: GCP. SeriousBreaches mhra. The sponsor must show that each activity of processing data has a lawful basis under this legislation, in addition to the common law basis. For health and social care research, the lawful basis is determined by the type of organization that is the data controller for the processing:. As described in the G-GDPR , with regard to transparency, the sponsor should understand whether personal data is collected indirectly from a third party or directly, as these determine the actions to take to comply with data protection requirements.
In most cases, the sponsor will need to provide transparency information about the legal basis and other details of processing personal data.
For details on complying with security and storage requirements, see GBR For additional information about consent and individual rights, see the Informed Consent topic, Documentation Requirements and Required Elements subtopics. The DPO assists the sponsor with monitoring internal compliance, informs and advises on data protection obligations, provides advice regarding Data Protection Impact Assessments DPIAs , and is a point of contact for participants and the supervisory authority.
To safeguard personal data within electronic health record EHR systems, G-EHRAccess provides guidance on updating these systems to ensure access by sponsors and their representatives e. In addition, the sponsor must maintain SOPs that cover system setup, installation, and use. The SOPs should describe system validation and functionality testing, data collection and handling, system maintenance, system security measures, change control, data backup, recovery, contingency planning, and decommissioning.
With respect to the use of these computerized systems, the responsibilities of the sponsor, investigator, and other parties should be clear, and the users should receive relevant training. The sponsor should inform the investigator s and the institution s in writing when trial-related records are no longer needed. The documents must be readily available to the MHRA upon request, and be complete and legible.
The storage system used during the trial and for archiving irrespective of the type of media used should allow for document identification, version history, search, and retrieval. The sponsor should ensure that the investigator has control of and continuous access to the data reported to the sponsor. If or when the sponsor performs an audit, the purpose of the audit should be to evaluate trial conduct and compliance with the protocol, SOPs, GBR , and other applicable regulatory requirements.
The sponsor should appoint auditors to review the clinical trial. The sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The extent and nature of monitoring is flexible and permits varied approaches that improve effectiveness and efficiency. The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring. The sponsor should document the rationale for the chosen monitoring strategy e.
In addition, the sponsor can contact the MHRA to put a trial on temporary halt or terminate a trial. If a sponsor suspends a trial temporarily, the MHRA must be notified. The notification should be made as a substantial amendment using the notification of amendment form GBR , clearly explaining what has been stopped and the reasons for the suspension.
To restart a trial that has been temporarily suspended, the sponsor must make the request as a substantial amendment using the notification of amendment form, providing evidence that it is safe to restart the trial.
Per the G-CTAuth and GBR , to terminate a trial, the sponsor must complete the end of trial declaration form GBR and include a brief explanation of the reasons for ending the trial, particularly when the trial has been terminated early. According to GBR , if it is discovered that noncompliance significantly affects or has the potential to significantly affect participant protection or reliability of trial results, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions.
Further, the sponsor should also inform the EC promptly and provide the reason s for the termination or suspension. As delineated in GBR , in the event of a multicenter clinical trial, the sponsor must ensure that:. GBR recommends establishing a Data Monitoring Committee DMC to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial. As set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6 R2 GBR , the sponsor is responsible for selecting the investigator s and the institution s for the clinical trial, taking into account the appropriateness and availability of the study site and facilities.
The MHCTR indicates that the sponsor must also ensure that the investigator s are qualified by training and experience. Additionally, the sponsor must define and allocate all study related duties and responsibilities to the relevant parties participating in the study.
Per GBR , if a multicenter trial is going to be conducted, the sponsor must organize a coordinating committee or select coordinating investigators. GBR provides guidance, background information, and templates of the commercial and non-commercial versions of the Organizational Information document. Foreign Sponsor Responsibilities. Additional foreign sponsor requirements are listed in Section 5.
See the Informed Consent topic, Required Elements subtopic for details on what should be included in the form. The MHCTR and G- ConsentPIS also specify that the oral and written information concerning the trial, including the ICF, should be easy to understand and presented without coercion or unduly influencing a potential participant to enroll in the clinical trial. In addition, the PIS forms part of the transparency information that must be provided to participants under the data protection legislation for the use and processing of personal data.
A physical or electronic copy of the signed consent form will still need to be provided to the participant. To record consent electronically, electronic signatures will be needed. Because there are different forms and classifications of electronic signatures, the researcher should determine what is appropriate for the particular study.
GBR-6 sets out the legal and ethical requirements for seeking and documenting consent using electronic methods also known as eConsent in the UK , as well as expectations regarding the use of electronic signatures. It also enables their informed consent to be documented using electronic signatures.
This approach can supplement the traditional paper-based approach or, where appropriate, replace it. Language Requirements.
Documentation Copies. The requirements vary depending on the point of collection of personal data directly or indirectly and the timing of the study i. A proportionate approach adopts procedures commensurate with the balance of risk and benefits so that potential participants are not overwhelmed by unnecessarily lengthy, complex, and inaccessible information sheets.
Participants should be provided with succinct, relevant, truthful information in a user-friendly manner that promotes their autonomy.
Specifically, the methods and procedures used to seek informed consent and the level of information provided should be proportionate to:. Note: the regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source. See the Informed Consent topic, Compensation Disclosure and Vulnerable Populations subtopics and the Specimens topic, Consent for Specimen subtopic for further information.
Compensation for Participation in Research. Compensation for Injury. See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF, and the Sponsorship topic, Compensation subtopic for information on sponsor requirements. The Right to Participate, Abstain, or Withdraw. The Right to Information. The Right to Privacy and Confidentiality. This is a key transparency requirement under the data protection legislation. These exemptions must be balanced with what is fair to participants.
As indicated in the G-GDPR , exemptions to data subject rights are not automatic, but must be considered on a study-by-study basis. It is important, therefore, to take into account the relevance of data rights to a particular study in the Participant Information Sheet PIS when offering or limiting the rights available to research participants.
If data rights have been previously offered or limited to participants that are not appropriate under UK-GDPR , then the PIS may need to be revised as a non-substantial amendment. The Right to Safety and Welfare. Special circumstances include medical emergencies and when a participant is mentally incapacitated.
Medical Emergencies. This situation also requires the EC to issue its approval beforehand. Mentally Incapacitated Persons. If the treatment to be provided is a matter of urgency and obtaining prior consent is not possible, incapacitated adult participants may be included in the trial once EC approval has been obtained. In Scotland, the provisions of Section 51 of the AIA govern the inclusion of adults lacking capacity in research. The G- ConsentPIS states that the UK allows adults not able to consent for themselves to be recruited into clinical trials without prior consent in emergency situations if the following conditions exist:.
GBR-3 , GBR-4 , and GBR characterize vulnerable populations as those who are dependent on others and are unable to express their opinion freely or make their own decisions. These participants may include children, persons with mental or physical incapacities, persons with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, prisoners, detainees, refugees, members of a group with a hierarchical structure, such as students, subordinate hospital and laboratory personnel, pharmaceutical industry employees, members of the armed forces, and persons kept in detention.
Additionally, precautions against possible physical and mental harms should be exercised. All pediatric participants should be informed to the fullest extent possible about the study in language and terms that they are easily able to understand. The rights of the minors should also be respected for their voluntary decision to participate in a clinical study. The G-ConsentPIS provides style guidance and suggestions for presenting age-appropriate information in the participant information sheet.
If the child does not assent, this should be respected. For women, researchers must give a clear warning to potential participants when there is a risk of harm to an unborn child or risk when breastfeeding. The information should include the need for pregnancy testing, contraceptive requirements, and how to report a pregnancy during the study.
The PIS should also provide information about what will happen if a participant becomes pregnant, including whether and how the researcher will monitor the pregnancy. For men, researchers must provide clear warnings and advice if the research treatment could damage sperm and consequently pose a risk to possible pregnancies. Information concerning the importance of careful contraception and what to do if their partner becomes pregnant is essential.
Specific advice for pregnant partners may be needed, including information on any compensation arrangements. Further, the G- ConsentPIS finds that the risk of harm caused during pregnancy is most likely when recruiting young people to a clinical trial for an investigational medicinal product CTIMP. In this case, there should be consent from someone over the age of 16, and the following should be done:. As set forth in GBR , any research studies involving women capable of becoming pregnant and breastfeeding women require additional safeguards to ensure the research conforms to appropriate ethical standards and upholds societal values.
According to GBR , the following conditions are required for research to be conducted with this population:. Per the International Council for Harmonisation's Guideline for Good Clinical Practice E6 R2 GBR , prisoners are considered vulnerable because incarceration could affect their ability to make a voluntary decision regarding participation in research.
A research study involving prisoners should ensure that these prospective participants are informed and are given the opportunity to make their own decisions without any interference from a higher authority. The ethics committee must also ensure that the study will be independently monitored to assure the dignity and rights of the prisoners involved in the research.
As per the MHCTR and GBR-9 , a recognized ethics committee EC within the Health Research Authority HRA , must approve the participation of adult research participants who are incapable by reason of physical and mental capacity to give consent, and must obtain advice from professionals with expertise in handling this patient population.
This consent should only be provided once the legal representative s or guardian s has had an interview with the investigator s to understand the trial objectives and risks, been provided with a point of contact for further information, and been informed of the right to withdraw the participant from the trial at any time. The G- ConsentPIS provides additional country-specific information on legal representative requirements.
As delineated in the MHCTR , a clinical trial of an investigational product may involve participants with mental incapacities under the following conditions:. This includes a product with a marketing authorization when it is used or assembled formulated or packaged in a different way from the approved form; when used for an unapproved indication; or when used to gain further information about an approved use.
The QP must satisfy the qualification and experience requirements delineated in the aforementioned sources. There will be a one-year transition period from January 1, to implement this guidance. The IB must contain all of the relevant information on the investigational product s IPs known as investigational medicinal products IMPs in the United Kingdom UK obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data.
See Section 7 of GBR for detailed content guidelines. As defined in GBR , the sponsor is also accountable for supplying the IMP, including the comparator s and placebo, if applicable. See Investigational Products topic, Product Management subtopic for additional information on IP supply, storage, and handling requirements. Per GBR , the sponsor must maintain a Certificate of Analysis to document the identity, purity, and strength of the IP s to be used in the clinical trial.
Per GBR , labeling for IPs must ensure protection of the participant and traceability, to enable identification of the product and trial, and to facilitate proper use of the IP.
As specified in GBR , for an IP to be used in a clinical trial, it must be properly labeled in the official language of the country where the trial is being conducted. As set forth in GBR , the following labeling information must be included on the primary package label or any intermediate packaging , and the outer packaging:. As per the MHCTR , a sample of the labeling is required as part of the clinical trial application submission.
See Clinical Trial Lifecycle topic , Submission Content subtopic for detailed clinical trial application submission requirements. Furthermore, according to GBR , the IP must also be suitably packaged in a manner that will prevent contamination and unacceptable deterioration during transport and storage.
The IB must contain all of the relevant information on the investigational product s IPs known as investigational medicinal products IMPs in the United Kingdom UK obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse event data.
The sponsor should also update the IB as significant new information becomes available. The sponsor must ensure the following:. As delineated in GBR , IPs should remain under the control of the sponsor until after completion of a two-step procedure: certification by the Qualified Person QP and release by the sponsor for use in a clinical trial.
Both steps should be recorded and retained in the relevant trial files held by or on behalf of the sponsor. Shipping of IPs should be conducted according to instructions given by or on behalf of the sponsor in the shipping order.
De-coding arrangements should be available to the appropriate responsible personnel before IPs are shipped to the investigator site. To help ensure the continuity of supply of medicines for clinical trials from January 1, , the BrexitLtr-IPs indicates that the UK will unilaterally recognize certain European Union EU regulatory processes for a time-limited period.
Record Requirements. As per GBR and GBR , the sponsor should inform the investigator s and institution s in writing of the need for record retention and should notify the investigator s and institution s in writing when the trial-related pharmacy records are no longer needed. Additionally, the sponsor must ensure sufficient quantities of the IP s used in the trial to reconfirm specifications, should this become necessary, and should maintain records of batch sample analyses and characteristics.
Sponsors would have to apply to MHRA, as well as to the EU concerned states; but MHRA would take every effort to ensure this parallel submission is as streamlined and efficient as possible for example by using the same application dossier.
MHRA and UK ethics committees are already internationally recognised for their robust yet timely assessment of trial applications, and the UK would provide an assessment outcome no later than the European timeframe. The current regulatory approval legislation will stay in place until such time as any changes are needed, so there will be no interruption in UK clinical trials approval whether for academic or industry-led clinical trials.
This is testing a new process that will result in a single UK decision on a clinical trial consisting of the current ethics opinion and MHRA clinical trial authorisation , in addition to a single clinical trial application route that incorporates both the Research Ethics Service and MHRA. Following the agreement in March of the implementation period, work to finalise the Withdrawal Agreement as a whole is continuing — with the intention to do so by October, alongside the framework for the future partnership.
The Government has always been confident that we will get a good deal - and now that good deal is clearer and closer than ever. The Government recognises that in the unlikely scenario of no deal between the UK and the EU, it would be important to reach a suitable resolution to the supply chain questions that would arise, particularly regarding Investigational Medicinal Products.
The Government has been consistent in saying that a key priority through the negotiations is to ensure that the UK remains one of the best places in the world for science and innovation. The Life Science Industrial Strategy set out a clear ambition to remain at the forefront of innovation, which includes a commitment to increase the number of clinical trials and to ensure the UK remains an attractive location for trials to take place, with a view to getting medicinal products licensed in the UK and elsewhere.
We are fully committed to continuing a close working relationship with the EU, in the interests of public health and safety. Technical information on what the implementation period means for the life science sector. Department of Health and Social Care statement on the implementation period. Book your coronavirus vaccination and booster dose on the NHS website.
To help us improve GOV. It will take only 2 minutes to fill in. Cookies on GOV. UK We use some essential cookies to make this website work. Accept additional cookies Reject additional cookies View cookies. Hide this message. Home Brexit. Part of Brexit. News story Clinical Trials Regulation. This news article was withdrawn on 31 January For current information on clinical trials see Clinical trials for medicines.
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