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Previous Updates are available below.
| DATE | REGiON | DOCUMENT | DESCRIPTION OF CHANGE | LINK |
|---|---|---|---|---|
| April 2022 | EMA | EMA has published guidance on managing the impact of the War in Ukraine on clinical trials: Advice to sponsors on managing the impact of the war in Ukraine on clinical trials | European Medicines Agency (europa.eu) | Link | |
| April 2022 | FDA | Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics | FDA has finalised its guidance on Master Protocols for oncology | Link |
| April 2022 | FDA | The FDA forms 1571 and 1572 expired on 31 March 2022, they have been approved without change and with a new expiry date of 31 March 2025. You can get the full Notice of Action via the link | Link | |
| May 2022 | EMA | EudraLex – Volume 10 – Clinical trials guidelines | EMA has also finalised the updated guidance documents on GCP Inspections in Eudralex Vol 10 chapter IV | Link |
| May 2022 | FDA | ELECTRONIC SUBMISSION OF IND SAFETY REPORTS TECHNICAL CONFORMANCE GUIDE | FDA has also updated its tech guidance on electronic submission of IND safety reports | Link |
| May 2022 | FDA | Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry | FDA has also published draft guidance on diversity plans for clinical trials | Link |
| June 2022 | EMA | Complex clinical trials – Questions and answers | EMA . CTFG Q&A on complex clinical trials | Link |
| June 2022 | EMA | Annual Report of the Good Clinical Practice Inspectors’ Working Group 2020 | EMA publishes Annual Report of the Good Clinical Practice Inspectors’ Working Group 2020. | Link |
| June 2022 | EMA | EMA Q&A on Clinical Trials Regulation updated in May 2022 | Link | |
| July 2022 | EMA | EMA has launched a pilot project evaluating analysis of raw data from clinical trials and the impact on Marketing Authorisation Application assessment | Link | |
| July 2022 | FDA | Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-forPurpose Clinical Outcome Assessments | FDA has published another draft guidance on Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments | Link |
| July 2022 | FDA | Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations | FDA has published guidance | Link |
| Sept & Oct 2022 | MHRA | GUIDANCE FOR FORMULATING RESPONSES TO GCP INSPECTION FINDINGS | MHRA has updated its guidance on CAPAs and responding to inspection findings Microsoft Word – Change is to refer to the Inspection report template and provide an example of an acceptable response. | Link |
| Sept & Oct 2022 | MHRA | Increasing the efficiency of your clinical trial authorisation (CTA) application and reducing the need for subsequent substantial amendments | MHRA has published a Blog post on improving efficiency of CTA applications including advice on streamlining the process, avoiding common mistakes and reducing the need for amendments. | Link |
| Sept & Oct 2022 | MHRA | Guidance on pharmacovigilance procedures | “The guidance on Pharmacovigilance Procedures has been updated to include further details on submission requirements for the MHRA, in particular relating to signals, Risk Management Plans (RMPs) and Post Authorisation Safety Studies (PASS). The section on Periodic Safety Update Reports (PSURs) has been updated with new requirements for submission of PSURs for products authorised in Northern Ireland. Additional sections have included on MHRA Safety Reviews and Safety Communications.” | Link |
| Sept & Oct 2022 | EMA | High-quality data to empower data-driven medicines regulation in the European Union | EMA and the Heads of Medicines Agencies have jointly published two documents on Data Quality for Medicines. These are open for public consultation until mid November and will be finalised next year. They will address quality criteria for data and also use of real world metadata. | Link |
| Sept & Oct 2022 | FDA | Advancing Real-World Evidence Program | FDA has an initiative to help organisations to use real world evidence. “ The Advancing RWE Program provides sponsors who are selected into the Program the opportunity to meet with Agency staff—before protocol development or study initiation—to discuss the use of RWE in medical product development. The Advancing RWE Program is an optional pathway for sponsors submitting RWE proposals; established procedures to engage with the Agency will continue to be available.”. This will begin in 2023. | Link |
| Sept & Oct 2022 | FDA | FDA has published final guidance on multiple endpoints in clinical trials. It’s intended to provide additional detail to supplement ICH E9 on | Link | |
| December 2022 | ICH | Transcelerate has published a set of resources to support implementation of ICH E8(R1) | Link | |
| December 2022 | MHRA | MHRA blog post clarifying the terms and the requirements for a temporary halt | Link | |
| December 2022 | FDA | New FDA proposed regulation on the DSUR – will replace the current requirements for an annual IND safety report with the DSUR as per ICH E2F | Link | |
| December 2022 | EFGCP | eConsent Initiative | EFGCP has launched an initiative to support eConsent | Link |
| January 2023 | EMA | RECOMMENDATION PAPER ON DECENTRALISED ELEMENTS IN CLINICAL TRIALS | Recommendation paper on decentralised elements of clinical trials which was adopted by ACT on 13 Dec 2022. Oversight; Consent; IMP at home; Trial procedures at home; Data collection, management and source; Monitoring | Link |
| January 2023 | EMA | Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice | 2 step batch release including unblinding information; Shipping and control of transport and transit conditions; Site to site transfer; Contracts/Technical Agreements. Guideline on sponsor responsibilities for handling and shipping of IMP – came into effect 1 January 2023: | Link |
| January 2023 | EMA | Eudralex Vol 10 chapter 5: Q&A document | Update Q&A document: New statements in Sponsor Responsibilities to confirm that all documents relating to a transitioning trial were previously approved; updates to sections on GCLP, patient facing documents, Use of licensed IMP, transitioning single country and multinational clinical trials to the CTD. | Link |
| January 2023 | EMA | Updated Q&A in EMA GCP Compliance section: GCP Matters Q17. This covers Sponsor Oversight including measures to be taken, documentation of oversight and issue management procedures. | Link | |
| January 2023 | MHRA | Good clinical practice for clinical trials | MHRA has also updated the pre-inspection documentation materials, Inspection Dossier Template, Clinical Trial Spreadsheet and Checklist. | Link |
| January 2023 | FDA | Draft guidance on Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products | This covers use of Real World Data and historical and concurrent external control arms. It talks about considerations for design, data and analysis. | Link |
| February 2023 | MHRA | Completed Paediatric Studies – submission, processing and assessment | MHRA has published guidance on the submission of completed paediatric studies | Link |
| February 2023 | EMA | Clinical Trials Regulation (EU) No 536/2014 in practice | EMA has published a quick guide to implementation of the Clinical Trials Regulation 536/2014 | Link |
| February 2023 | EMA | EudraLex – Volume 10 – Clinical trials guidelines | The guidance on Serious Breaches is now available in Eudralex Vol 10 Chapter V and there is also a standard form which is titled “Appendix IIIb – Information to be submitted with a notification of a serious breach” | Link |
| February 2023 | EMA | Q&A on the protection of commercially confidential information and personal data while using CTIS | EMA has published a Q&A document on protection of commercially sensitive information when using CTIS | Link |
| February 2023 | MHRA | Announcement | the UK government has announced that there is to be an independent review into the UK commercial clinical trials landscape. Commercial trials have declined in recent years | Link |
| February 2023 | MHRA | Blog post | MHRA has published a blog post on manufacture of Investigational Medicinal Products. There is some guidance provided on manufacturing vs reconstitution and then a Q&A section. | Link |
| 7 March 2023 | EMA | Guidance on computerised systems and electronic records | As you would expect it covers data integrity (ALCOA++), validation, data protection, security and much more. | Link |
| 21 March 2023 | MHRA | Response to the public consultation regarding proposals for updates to UK Clinical Trials Legislation. | MHRA published their response to the public consultation which ran in 2021-22 regarding their proposals for updates to UK Clinical Trials Legislation. They outline the changes they will be taking forward into new laws and the next step is for them to draft the new legislation. | Link |
| 12 February 2023 | MHRA | Inspection metrics report for 2019-2020 | As in previous years Pharmacovigilance features highly in critical findings and particularly issues with use of Reference Safety Information. | Link |
| March 2023 | FDA | Draft Q&A document on Electronic Systems, Records and Signatures in Clinical Trials | Link | |
| 24 March 2023 | FDA | Draft guidance aimed at improving clinical trial design for oncology studies to support accelerated approval | Link | |
| March 2023 | FDA | BIMO inspection report 2022 | One thing which comes up quite a bit in the common findings is failure to maintain adequate records. | Link |
| 30 March 2023 | EMA IWG | EMA GCP IWG points to consider regarding the management of ongoing clinical trials impacted by political conflicts, natural disasters or other major disruptions | This document provides advice based on recent experience during Covid and the war in Ukraine | Link |
| April 2023 | FDA | Draft Guidance: Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision making | Technical guidance on choice and justification for COA, and interpretation of results | Link |
| April 2023 | FDA | Final Guidance: A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers | This document builds on the previous guidance document on Risk Based Monitoring, and provides additional guidance on the monitoring approach and plan. | Link |
| 11 April 2023 | EMA | Updated CTIS Sponsor Handbook | – Recording sites locally in CTIS (section 2.2.2) new; – CTIS Bitesize Talks links new; – Multi-factor authorisation in CTIS (section 2.1.1) new; – Multiple Q&A reference links added (section 10.6) updated – Glossary (section 12) updated | Link |
| 20 April 2023 | International | CIOMS Glossary of ICH Terms and Definitions | This is the 3rd version of this consolidated glossary covering all 4 work areas of ICH | Link |
| May 2023 | FDA | Decentralised Clinical Trials for drug products, biologicals and devices | Draft guidance on Decentralised Clinical Trials for drug products, biologicals and devices – FDA’s recommendations on various aspects of running DCTs | Link |
| 19 May 2023 | ICH | E6(R3) Step 2 draft | ICH GCP update has now reached step 2 for public consultation | Link |
| 26 May 2023 | UK | O’Shaughnessy report into commercial clinical trials | Results of an independent review and containing recommendations to improved the commercial clinical trial landscape in the UK | Link |
| 26 May 2023 | UK | Government response to O-Shaughnessy report | UK government response to recommendations | Link |
| 26 May 2023 | UK | HRA response to O-Shaughnessy report | HRA response to findings and recommendations | Link |
| May 2023 | FDA | Paediatric drug development | FDA has published two draft guidance documents on Paediatric drug development: revisions of the Regulatory Considerations guidance and the Scientific considerations guidance | Links |
| June 2023 | EMA | Three new Q&As: D3 Remote access to identifiable personal and health data | EMA has added 3 new questions to the GCP Considerations Q&A Page B11 covers vendors conducting services for investigators. B18 covers use of productivity apps in clinical trials, D3 covers requirements if remote access to records is needed. | Link |
| July 2023 | EMA | CTIS and personal data protection | EMA has updated this interim guidance document | Link |
| July 2023 | ICH | Reflection paper on RWE | ICH has issued for consultation this paper on terminology and principles for use of Real World Evidence | Link |
| 10 July 2023 | EMA | Guidance on data protection while using CTIS | Guidance for sponsors on how to handle personal and commercially confidential information | Link |
| 19 July 2023 | EMA | Guidance on Transition of CTs from CTD to CTR | Guidance for sponsors | Link |
| 26 July 2023 | EMA | Q&A’s on EMAs policy (0070) regarding publication of clinical data | Update on restarting this process which was halted due to Covid. Publication restarted in Sept and this document provides guidance | Link |
| August 2023 | FDA | Guidance on Informed Consent | Updated guidance on process and requirements for informed consent | Link |
| August 2023 | EMA | New Q&A on updated IBs and ICFs | Guidance on distribution of new documents to investigational sites | Link |
| August 2023 | FDA | Guidance on use of RWD/RWE in Regulatory decision making for Drugs and Biologics | Finalised guidance now available | Link |
| Sept 2023 | FDA | Considerations for the conduct of clinical trials of medical Products during emergencies | Guidance from FDA about how to manage disruptions to clinical trials due to emergency situations | Link |
| Sept 2023 | FDA | IRB review of individual patient expanded access | FDA recommendations on procedures and factors to consider | Link |
| 29 Sept 2023 | MHRA | UK wide labelling | New guidance on labelling for the UK including Northern Ireland | Link |
| 29 Sept 2023 | MHRA | UK Wide licensing | New guidance on applications for UK wide Product Licence including Northern Ireland | Link |
| October 2023 | EMA | Revised transparency rules for CTIS | New guidance and rules on clinical trials transparency – deferral system removed | Link |
| 3 Oct 2023 | MHRA | International Recognition Procedure | New provision for MAA approval taking into consideration approvals from specified Reference Regulators | Link |
| 12 October 2023 | MHRA | Notification Scheme for lower risk Clinical Trials | New notification scheme – 14 day approval for lower risk trials | Link |
| November 2023 | MHRA | Common issues with CTA applications | MHRA updated its page on Common issues with CTA applications. It’s been updated with a link to CTFG guidance on contraception and pregnancy testing in clinical trials. | Link |
| November 2023 | UK | Response to the O-Shaughnessy review | The UK government updated its response to the O-Shaughnessy review. This page provides information on the original response from May 2023 and progress on implementation since then. It also discusses next steps for the implementation of the recommendations in Lord O’Shaughnessy’s report. | Link |
| November 2023 | HRA | New requirements for information for participants | HRA in the UK finalised new requirements for information for participants. They have published new standards for information to be given to people asked to participate in research. There is a Quality Standards document and a Design and Review Principles one. These requirements will be mandatory for all submissions from 1st December!, | Links |
| November 2023 | FDA | Guidance documents providing technical specifications for submitted specific kinds of data | FDA published two new guidance documents providing technical specifications for submitted specific kinds of data: 1) Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory 2) Submitting Patient Reported Outcome Data in Cancer Clinical Trials 1 | 2 |
| December 2023 | FDA | Guidance for Industry, Investigators and Other Stakeholders: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations | This guidance provides recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products. Use of DHTs as recommended in this guidance may improve the efficiency of clinical trials for sponsors, investigators, and other stakeholders and may increase the opportunities for individuals to participate in research and make participation more convenient. | Guidance for Industry |
| December 2023 | FDA | Guidance for Industry: Data Standards for Drug and Biological Product Submissions Containing Real-World Data | FDA has created a framework for a program to evaluate the potential use of real-world data (RWD), to generate RWE to assist with the support the approval of new indication(s) for drugs already approved under section 505(c) of the FD&C Act (21 U.S.C. 355(c)); or to help support or satisfy post-approval study requirements (RWE Program). This guidance supersedes the guidance for industry entitled Draft Guidance for Industry: Data Standards for Drug and Biological Product Submissions Containing Real-World Data, Oct-2021 (IDRAC 337234). | Access the guidance here. |
| December 2023 | FDA | Draft Guidance for Industry: Master Protocols for Drug and Biological Product Development | This guidance document provides recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on the submission of documentation to support regulatory review. | Download it here. |
| January 2024 | EMA | EMA Inspections: Questions and Answers on Good Clinical Practice (GCP) | This document provides a list of questions and answers on the various GCP topics. It has been updated to update question 19 “What are the expectations for distribution of updated Investigator’s Brochures (IBs) and updated Informed Consent Forms (ICFs) to clinical sites/ investigators?” to add the reference legal framework the sponsors should refer to for the start of the use of the new Reference Safety Information (RSI). | This document supersedes the previous version dated Aug-2023. |
| February 2024 | INTERNATIONAL | Declaration of Helsinki | The World Medical Association has proposed updates to the Declaration of Helsinki (which covers ethical requirements for all medical research using human participants). This has been subject to public consultation which closed on Feb 7th. | See the proposal here. |
| February 2024 | FDA | Draft Guidance For Industry : Use of Data Monitoring Committees in Clinical Trials | This guidance provides recommendations to help sponsors of clinical trials determine when a data monitoring committee (DMC) (also known as a data and safety monitoring board (DSMB) or a data and safety monitoring committee (DSMC) or an independent data monitoring committee (IDMC)) would be useful for trial monitoring and what procedures and practices should be considered to guide their operation. | Download the document here. |
| February 2024 | FDA | CDER BIMO Metrics report for 2023 | This is the summary of findings from FDA inspections during 2023 | Link |
| March 2024 | EMA | Sponsor Quick Guide to CTR And Q&A Document on CTR | Both documents have been updated: e.g.transparency of information, notification of out-of-spec admin on ATMPs, updates to PV examples, Updates to Annexes in Q&A document. | Document 1 |
| March 2024 | EMA | Sponsor Quick Guide to CTR And Q&A Document on CTR | Document 2 | |
| March 2024 | EMA | Guidance for the Transition of Clinical Trials from the Clinical Trials Directive to the Clinical Trials Regulation. | Clarification and updates to guidance for sponsors. | Download the guidance here. |
| March 2024 | EMA | Guidance on Auxiliary Medicinal Products | This guidance has been updated with some clarifications on classification and applicability and an additional flowchart on labelling requirements for AxMPs | LinkLink |
| March 2024 | FDA | Draft Guidance: Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards, | Guidance on the content, organisation and presentation of Information for Participants with the aim of making sure participants can understand the information presented. | Link |
| April 2024 | FDA | Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry | New Guidance Document for electronic reporting of SUSARs. | Link |
| April 2024 | FDA | Guidance for Bioavailability and Bioequvalence studies (BA/BE): | There are new guidance documents in this area. | Electronic submission of IND Safety Reports from IND exempt BA/BE studies (final) |
| Data Integrity (draft) | ||||
| Handling and Retention of samples (draft) | ||||
| March 2024 | FDA | Technical Specifications Document: Study Data Technical Conformance Guide (Version 5.7) | This Study Data Technical Conformance Guide provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported data standards. | Link |
| April 2024 | FDA | Draft Guidance: Real World Evidence: Considerations regarding non-interventional studies | This covers Design, Data Sources and Analytical Approach. | Link |
| April 2024 | MHRA | MHRA Guidance: The Target Development Profile Toolkit | This document was revised on 5th April to incorporate the changes highlighted below: The following sections were deleted: – sections “Adaptive Inspections” – “Certifications “Enhanced patient engagement – “Novel methodology and innovative clinical trial design – design “Rapid Clinical Trial Dossier Pre-Assessment” and – “Forthcoming tools.” The email ID enquiries@cprd.com in the section “Clinical Practice Research Datalink (CPRD) Assisted Patient Recruitment” was updated. “Safe harbour engagement meetings” was replaced with “NICE Advice” in the section “How it works.” | Link |
| April 2024 | FDA | Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry, April 2024 | There is a new Guidance Document for electronic reporting of IND Safety Reports, which will be effective from April 2026. | Link |
| April 2024 | FDA | Draft Guidance for Industry, IRBs, and Clinical Investigators: Cancer Clinical Trial Eligibility Criteria: Performance Status; Washout periods and Concomitant medications; Laboratory Values | These are in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by CDER and CBER for the treatment of cancer. Aim is to improve diversity in oncology clinical trials. | Document 1 |
| Document 2 | ||||
| Document 3 | ||||
| April 2024 | FDA | Announcement | The Food and Drug Administration (FDA) published this notice to announce the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI aims to be a central hub within CDER that supports innovative approaches to clinical trials that are designed to improve the quality and efficiency of drug development and regulatory decision making. | Link |
| April 2024 | EMA | EMA/CHMP/150527/2024: Reflection Paper on Use of Real-World Data in Non-Interventional Studies to Generate Real-World Evidence | This Draft document provides guidance on the use of real-world data in non-interventional studies to generate real-world evidence and is open for public consultation until 31 August. | Link |
| May 2024 | EMA | Guidance for the Transition of Clinical Trials from the Clinical Trials Directive to the Clinical Trials Regulation, Version 4, May-2024 | This revised document of the European Commission provides Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation. The following changes have been made: • New section 4. • New Annex II. • Clarification of consequences of non-compliance with transition requirements, as well as on the interface with medical devices and in vitro diagnostics, and active sites. • Minor amendments to elements related to the CTIS transparency rules. • Addition of information on EE and EL in Annex I. • Sections 1, 6, 9 and 10 have been updated. | Link to the full document |
| May 2024 | International | ICH Guideline Topic M12 Step 4: Drug Interaction Studies, plus a Q&A document. | This guideline provides recommendations to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in-vitro and clinical drug-drug interaction (DDI) studies during the development of a therapeutic product. This is the final version of this guideline. | Link to the updated document |
| Link to the Q&A document |
