Vyvgart

Active substance efgartigimod alfa
Holder Argenx
Status Running
Indication add-on to standard therapy treatment for patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and who demonstrate inadequate response to conventional treatments, are not clinically eligible or with contra-indication to treatment with approved

Important for clinical trials sponsors: mandatory use of E-Submission Food Chain platform for clinical trials with genetically modified medicinal products

Since 1 October 2022, all Summary Notification Information Format documents submitted with applications for clinical trials with medicinal products, entirely or partly composed of genetically modified organisms covered by Directive 2001/18/EC for deliberate release, must be submitted through the E-Submission Food Chain platform.

New Clinical Trial Regulation: new transition phase, possible delays in the processing of substantial modifications, and information sessions for sponsors

The new Clinical Trial Regulation 536/2014 (CTR) entered into force on 31 January 2022. This new regulation on clinical trials applications of medicines for human use aims to simplify administration and harmonise legislation within the European Union. On 31 January 2023, a new transition phase will start and from then on all initial clinical trial applications have to be submitted via CTIS. The FAMHP is organising two information sessions on the clinical trials regulation.

Questions and answers on qualified persons

May QPs recognised before 28 January 2022 still release batches of veterinary medicinal products?
Yes, QPs that were recognised before Regulation (EU) 2019/6 came into effect on 28 January 2022 may still release batches of veterinary medicinal products in addition to batches of medicinal products for human use.

May a QPHum recognised from 28 January 2022 release batches of veterinary medicinal products? 
A QPHum may only release batches of medicinal products for human use.

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