Category Clinical trials

HPRA Newsletter 76 – Includes information on transition to the CTR, Brexit and multilingual DCP packaging pilot

Issue 76 (February 2024) of the HPRA Medicinal Products Newsletter has been published. As usual, it is packed with information and includes (but is not restricted to) the following information: 1) Clinical trials applications – Important dates and information Applicants…

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Following public consultation, MHRA to streamline clinical trial approvals in biggest overhaul of trials regulation in two decades

Last updated:16 August 2023 See updates at the end of the post. The UK MHRA will introduce a series of new measures with support from partners to make it faster and easier to gain approval and to run clinical trials…

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Swissmedic position paper on Decentralised Clinical Trials with medicinal products updated

Last updated: 22 December 2022 Swissmedic has updated its position paper on Decentralised Clinical Trials (DCTs) with medicinal products from version 1.1 to version 2.0 of 15 December 2022. According to Swissmedic, revisions and clarifications have been added where necessary.…

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TGA publishes new guidance on the GCP inspection of clinical trial sites for investigational products

The TGA has published new guidance entitled Good Clinical Practice (GCP) inspection program – Guidance for GCP inspection of clinical trial sites for investigational biologicals and medicinal products Clinical trials of medicines and biologicals regulated under the Clinical Trial Notification…

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