Uitgelicht en gespot op internet (week 50, 2020)

Een verzameling van nieuwsberichten die de afgelopen weken zijn gespot op het internet:

Associatie van Contract Research Organisaties in Nederland (ACRON)


From January 1st, 2021, for all clinical trials recorded in EudraCT that are ongoing in the EU/EEA:

  1. Sponsors established in the United Kingdom prior to 31 Dec 2020, must as of 1 January 2021 be legally established in the EU/EEA or have a Legal representative who is legally established in the EU/EEA.
  2. Legal representatives established in the United Kingdom prior to 31 December 2020 can no longer act as a legal representative of a UK sponsor as of 1 January 2021.
  3. Qualified persons established in the United Kingdom other than in Northern Ireland can no longer certify batch-release of an IMP for use in EU/EEA as of 1 January 2021 and must be established either in the EU/EEA or in Northern Ireland.

Sponsors are requested to update these requirements in sections B.1, B.2 and/or D.9.2 of the Clinical Trial Application (CTA) form, as appropriate, using the EudraCT application … . The amended XML file of the CTA will then need to be submitted to all the relevant National Competent Authorities where the trial is submitted/ongoing.


In addition, from January 1st, 2021 sponsors will be able to perform the following changes in the CTA:

  • Update section B.2 with a EU/EEA legal representative, for trials with sponsors based in UK
  • Update section D. specifying “Northern Ireland” in the country field

When submitting the updated XML file of the CTA to the National Competent Authority, the sponsor is requested to make a reference to the relevant substantial amendment form already submitted.

-Bron: EudraCT Public website d.d. 7 december 2020




Data sharing

Decentralized Trials & Research Alliance (DTRA) 

European Data Protection Supervisor (EDPS)

European Medicines Agency (EMA), Clinical Trials Information System (CTIS), ECTR


International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Ministerie van Volksgezondheid, Welzijn en Sport (VWS)

Patient Focus Development



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