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on the CMDh website . Active Substance Master File Worksharing. In January 2024, the CMDh approved an update to the document " The worksharing procedure for the assessment of Active Substance Master File [...] topics. NEWSTICKER 30.06.2024 RECENT COMMITTEE NEWS Medicinal products containing estragole as an active substance or excipient. The CMDh reminds marketing authorisation holders/registration holders of [...] medicinal products ((T)HMPs) containing plants or their preparations containing estragole either as an active substance or as an excipient to check whether their medicinal products comply with the guidance published
a so-called "specification". In this specification it is determined whether or to what extent the active ingredient content may be reduced so that the indicated efficacy is still fully guaranteed. Quality [...] added depending on the dosage form. For example, in the case of tablets, the time during which the active substance is released must be defined, or in the case of parenteral administration - such as infusion [...] storage conditions (e.g. for vaccines and insulin), this can lead to a loss of quality. For example, active ingredients in solutions can precipitate due to cold, and the consistency of ointments can change
patches Proper disposal of transdermal patches is particularly important as large amounts of the active ingredient may still be present in the patch after use. It may have serious consequences up to and [...] of patches if they chew on them, respiratory arrest may occur. Even transdermal patches with other active ingredients such as nicotine or hormones can cause serious side effects. To protect others and the
safety and efficacy of a vaccine are reviewed based on preclinical and clinical data. The official activities form a very complex safety net at all levels in the life cycle of a drug or vaccine: clinical trials
clinical trial must be sufficiently qualified by education, training and experience to perform their activities. For medical procedures or medical care reserved for a physician a qualification as a physician [...] training). National fees March 28, 2023 Member States may charge fees for the performance of the activities resulting from Regulation (EU) 536/2014. However, Member States should avoid having to make multiple [...] different bodies involved in the assessment of the clinical trial application. Therefore, fees for activities under Regulation (EU) 536/2014 are collected by the Federal Office for Safety. In accordance with
Tasks and Activities Tasks of BASG according to GESG Activities of BASG Tasks of BASG according to GESG Pursuant to Gesundheits- und Ernährungssicherheitsgesetz ( GESG ) § 6a. (1) The Federal Office for [...] Office for Safety in Health Care gives scientific advice on the development of medicinal products. Activities of BASG Scientific Advice Admission of Clinical Trials Marketing Authorisation and Lifecycle Management