Your medicine and health products
| 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 productsSince 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.
Clinical trials with genetically modified medicinal productsSince 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. End of the validation procedure for SARS-CoV-2 antigen self-testsThe validation procedure for SARS-CoV-2 antigen self-tests with a CE-certificate ceases to apply from 23 January 2023. The associated list of recommended SARS-CoV-2 antigen self-tests with a CE-certificate is no longer available on the same date. Point of contact at authorisation holders for the supply and availability of medicinal productsThe FAMHP reminds marketing authorisation holders for medicinal products for human use to register a single point of contact (i-SPOC) for the supply and availability of medicinal products through the IRIS platform of the EMA.
New Clinical Trial Regulation: new transition phase, possible delays in the processing of substantial modifications, and information sessions for sponsorsThe 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 personsMay QPs recognised before 28 January 2022 still release batches of veterinary medicinal products? May a QPHum recognised from 28 January 2022 release batches of veterinary medicinal products? |