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Editorial
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Author: Dr Michaela Gottwald, FORUM
Institut für Management GmbH
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On 13 January 2025, a webcast took place as part of the Online Pharma FORUM, this time on the topic of "The New German Medical Research Act".
... Read more
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News from ICH |
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The ICH E6(R3) "Good Clinical Practice" Guideline reaches Step 4 of the ICH process. It provides a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities
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News from European Commission |
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The European Commission published the new EU rules on EU-HTA.
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The European Commission published the EU-HTA implementation plan.
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The EU Commission published the outcome of the PICO exercises (EU-HTA).
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Dr Paul de Boissieu (HAS) addresses the topic "Joint clinical assessment according to the implementing act" at the course "JCA Dossiers & Joint Clinical Assessments"
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The Joint Action on Respiratory Diseases (JARED) will hold its kick-off meeting. JARED is a three-year collaboration between 14 Member States, Iceland, Ukraine and Moldova, led by Hungary and will focus on tackling chronic respiratory diseases (CRDs).
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News from EMA |
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The first full version of the European Shortages Monitoring Platform (ESMP) became available on 29 January 2025. To access the platform, please follow the link:
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From now on all clinical trials in the European Union (EU), including ongoing trials that were approved under the previous legal framework, the Clinical Trials Directive (CTD), are governed by the Clinical Trials Regulation (CTR).
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The Draft reflection paper "on the use of information in European Union herbal monographs and assessment reports for borderline issues" can be commented on by 1 May 2025.
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EMA has published an EU-IN Horizon Scanning Report on "Nanotechnology-based medicinal products for human use".
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Veterinary news |
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The draft reflection paper "on the qualification of non-mutagenic impurities" can be commented on by 30 April 2025.
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EMA published a concept paper for the development of a guideline on quality aspects of mRNA vaccines for veterinary use. It can be commented on by 8 April 2025.
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Kind regards,
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Dr Rebekka Bitsch
Your contact for
Regulatory Affairs (Human)
+49 6221 500-565 |
Dr C. Michaela Gottwald
Your contact for
Regulatory Affairs (Veterinary)
+49 6221 500-610 |
Dr Birgit Wessels
Your contact for
CMC
+49 6221 500-652 |
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Verena Planitz
Your contact for
Global Regulatory Affairs
+49 6221 500-655
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