Uitgelicht en gespot op internet (week 37, 2022)

• Convergence: EU official says no delay to CTIS implementation, despite industry concerns (15-09-2022). Regulatory Focus.
• EU Clinical Trial Regulation: Get Ready to Adapt! (september 2022). Global Forum.

• CTEG Meeting Minutes d.d. 06-07-22

Agenda

• • • Updates on Q&A
      • a. Patient facing documents
      • b. Transition trials
      • c. Labelling of the IMPs
      • d. Reference to CTD
    • Templates
      • a. Statement GDPR compliance
      • b. Updates Part II template
      • c. Update QP template
    • Interpretation of Art 61 § 5
    • DCT project work
    • Updates on the Delegated Regulation on labelling requirements for unauthorisedinvestigational and unauthorised auxiliary medicinal products for human use
    • ICH-GCP guideline updates
    • Call for a speaker for a workshop on Digital health Technology 8th and 9th November
    • AOB
      • Interplay between CTR (EU) 536/2014 regulation and Regulation (EU) 2017/745 or /746 on (In vitro)medical devices
      • Labelling language

• Best Practice Guide for Sponsors of document naming in CTIS (16 september 2022 gepubliceerd).

In order to simplify the re-submission process to CTIS CTCG accepts that the CT numbers within the documents uploaded into the system are shortened concerning the last 2 digits which only show how often the sponsor created previous submissions and re-submitted the applications.

In case of a decision letter the full number including the last 2 digits will be reflected.

If the full number is reflected in the documents and a re-submission takes place, there is no expectation that these numbers are immediately corrected within the documents during the ongoing procedure. This can be done at a later stage when the documentation is updated during a SM procedure.

bron: HMA CTCG Key documents list

• SAFE CT – Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials (september 2022).

The new Clinical Trial Regulation EU No. 536/2014 and Implementing regulation (IR) which came into force on 31 Jan 2022introduced the concept of safety cooperation and work-sharing among Member States (MSs)

Joint Action (JA) 12 of the EU4Health Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials or SAFE CT supports these new concepts through provision of additional resources and expertise necessary to implement the new regulation.

The goal of this JA is to establish and maintain cooperation in safety data assessment in clinical trials via building capacities and performing training activities in the participating MSs. The experience gained during the JA will be used to update and improve the procedures on cooperation and training in safety surveillance in clinical trials.

The project is currently in grant agreement preparation phase and will run for 36 months (with a retrospective start date from 01/05/2022 – 01/04/2025).

bron: HMA CTCG SAFE CT

• CTCG recommendation to sponsors on managing the impact of the war in Ukraine on clinical trials (Updated July 2022).

• Protection of personal data and commercially confidential information (CCI) for documents uploaded and published in the Clinical Trials Information System (CTIS): Workshop on draft guidance (updated 12-09-2022).

• Gedelegeerde Verordening (EU) van de Commissie van 6 september 2022 tot wijziging van Verordening (EU) nr. 536/2014 van het Europees Parlement en de Raad wat betreft etiketteringsvoorschriften voor niet-toegelaten geneesmiddelen voor onderzoek en niet-toegelaten auxiliaire geneesmiddelen voor menselijk gebruik. (EN)