June 2023

Medicines and Vaccines

ICH

  1. A fully virtual multi-stakeholder workshop on ICH E6 R3 public consultation is being organised by ACT EU Priority Action 4 (PA4) on 13 – 14 July 2023. The first session on 13 July is live broadcast whilst the second session on 14 July is not publicly broadcast and attendance is by pre-registration only (closed on 16 June 2023).
  2. An overview of comments from the public consultation on the ICH M11 guideline, template, and technical specifications have been published. These comments will be sent to the ICH M11 EWG for consideration in the context of Step 3 of the ICH process.

  3. Press Release: ICH Assembly Meeting, Vancouver, Canada, June 2023. This includes details on new areas of harmonisation adopted, alongside significant advancement of ongoing activities.

    The Assembly will progress a new ICH Reflection Paper titled “International Harmonisation of Real-World Evidence Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using Real-World Data, with a Focus on Effectiveness of Medicines”. The paper, which presents opportunities for development of new ICH Guidelines, will be made available on the ICH website for public consultation recognising the value of broader input on this topic.

  4. On 27 June 2023, ICH announced a collaboration between MedDRA and WHO International Classification of Diseases (ICD). Read the press release.

CTR and CTIS

  1.  A video recording of the CTIS: Walk-in clinic held 17 May 2023 is now available to view.
  2. The launch of the multi-factor authentication (MFA) strategy for user logins to CTIS, for both Sponsor and Member State workspaces, was delayed but was implemented on 8 June 2023. Instructions on setting up MFA for EMA systems can be found here.

  3.  A CTIS bitesize talk entitled How to submit a transitional trial in CTIS was held on 21 Jun 2023 (15:30-17:00 CEST). A video recording will be made available after the event typically taking up to 60 days. A further information event on transitional trials will take place on 04 July 2023, 13:00 – 17:30 CET.

  4. Reminder: resubscribe here to receive the Clinical Trials Highlights Newsletter. The next issue will be circulated mid-July 2023 only to the re-subscribers.

  5. Sponsors can express their interest in gaining access to the CTIS Training Environment by filling in the ongoing survey. The training environment is a simulation of CTIS used in production and allows users to get familiar with system functionalities.

  6. EMA is organising a virtual CTIS: Information Day on 17 Oct 2023, from 13:30- 17:30 Amsterdam time (CET) “to support sponsors of clinical trials in preparing and proceeding with the transition to meet the deadline of 30 January 2025”. Commercial and non-commercial sponsors with experience in transitioning trials as well as representatives from EMA and EU/EEA member states will share insights and best practices.

The registration for the event is through DIA Europe and it is a paid event.
Ample time is foreseen for Q&A. Participants are invited to submit related questions by 03 October 2023 to emaevents@diaglobal.org.

FDA Guidance and News

  1. FDA is proposing to amend its human prescription drug labeling regulations to require a new type of Medication Guide—"Patient Medication Information”. Patient Medication Information would be an “FDA-approved, one-page document that follows standardized format and content requirements.” An example can also be found at the link above. The proposed rule is available for public comment for 180 days.

  2. On 6 June 2023, FDA released updates of its recommendations for good clinical practices (GCPs) which the agency says “is meant to modernise the design and conduct of clinical trials and make them more agile.” The draft guidance is adopted from the International Council for Harmonisation (ICH) recently updated E6(R3) draft guideline. The FDA draft guidance will be open for public comment for 60 days. The ICH Expert Working Group will review and consider comments on this draft guidance, as well as feedback from other ICH member countries before finalising the ICH guideline.

  3. In light of the growing interest in the therapeutic potential of psychedelic drugs in recent years, FDA published its first new draft guidance for designing clinical trials for psychedelic drugs. It highlights fundamental considerations to researchers investigating the use of psychedelic drugs for potential treatment of medical conditions such as psychiatric or substance use disorders. Comments are to be submitted until 25 August 2023.

  4. The modernised ClinicalTrials.gov is now available. To allow users time to adapt to the modernised website, the classic ClinicalTrials.gov website will remain available until it's retired in 2024.

EMA Guidance and News

  1. A recording of 16 May 2023 Clinical Data Publication (Policy 0070) re-launch - EMA webinar can be viewed online. The presentation includes details of the new Anonymisation Report Template. According to the webinar the relaunch applies to new active substances from September 2023 CHMP and includes negative and withdrawn products. Covid-19 and other public health emergency clinical data publication continues. In this Part 1 of the relaunch, there is no plan to request clinical data for products authorised during suspension of Policy 0070. Pre-submission meetings will be offered and some changes will be made to improve efficiency and continue work with Health Canada. 

Policy 0070 Relaunch Key Messages:

  • Invitation letters will be sent if your product is in scope
  • Start to prepare package early prior to CHMP Opinion – in house or vendor chosen
  • Sponsor should avail themselves of pre-submission meeting – product specific 
  • Review that any CCI proposed is not already in public domain
  • Identify any out of scope sections and mark appropriately
  • Complete QC check prior to submission – all documents present
  • Contact EMA for any specific product issues

2. EMA has published metrics on the Clinical Trials Regulation (CTR) and Clinical Trials Directive (CTD) over the period 01 to 31 May 2023, edition 14 in the form of KPIs to Monitor the European Clinical Trials Environment.

  1. CIOMS Working Group XII draft report Benefit-Risk Balance Medicinal Products is published for public consultation.

Transparency and Disclosure Resources and News

  1. 1. The PHUSE Data Transparency Summer Event took place 20-22 June 2023. and consisted of live presentations and a joint panel discussion/Q&A session. The recordings are now available on the PHUSE Engagement Hub.

  2. The EU General Court examined data anonymisation and pseudonymisation and has affirmed that even if identification is theoretically possible, data is not “personal data” if the steps needed to identify are “prohibited by law or practically impossible” or involve “a disproportionate effort in terms of time, cost …”.

Development Strategy News

  1. EMA Q&A Impact Mutual Recognition Agreement (MRA) between EU and US dated 31 May 2023 is available.

Real-World Data 

  1. EMA live broadcast on the use of RWE in regulatory decision-making on 26 June and 27 June. This was a multi-stakeholder workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use. Keep checking the page as a recording may eventually be posted. 

  2. Use of real-world evidence in regulatory decision making – EMA publishes review of its studies: This press release highlights some of the findings of a report published on 23 June 2023 on the experience EMA has gained in conducting studies with real-world data (RWD) in the past year and a half. The report is part of the Agency’s efforts, alongside the European Medicines Regulatory Network (EMRN), to enable use of RWD in regulatory decision-making.

  3. FDA has a new initiative ‘Facilitating Review of Real-World Data Studies: The Oncology QCARD Initiative’.The Oncology QCARD Initiative was designed to facilitate effective communication between study sponsors and protocol reviewers by evaluating the potential minimum elements for sponsors to consider when assembling submissions for review of a proposed study and RWD source(s). Details about the Oncology QCARD Initiative are available on the OCE Real World Evidence (RWE) website.

CORE Reference Webinar 21 June 2023 

The EMWA Webinar titled 'CORE Reference - Value for the Global Regulatory MW Community' was held on 21 June 2023.

Topics included:

  • Website (www.core-reference.org) and resources
  • Practical utility of CORE Reference, including PDF open-book demonstration
  • Transparency and disclosure in Asia
  • EMA Policy 0070 relaunch 2023
  • Q&A

The Webinar recording, transcript of the chat, and PDF of the slides are available here: https://emwa.org/education/public-webinars/.  

Please share these resources widely in your professional communities. 

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