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News from the EU Commission |
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HERA plays an important role in bringing medical countermeasures to the market in the fight against Antimicrobial Resistance (AMR), as outlined in a new study published by HaDEA.
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The eHealth Network has published the guideline on the exchange of health data under Cross-Border Directive 2011/24/EU - Patient Summary.
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News from the ICH |
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The ICH S12 Guideline on nonclinical biodistribution considerations for gene therapy products will come into effect on 30 September 2023.
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The ICH M7(R2) Guideline on the "Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk" and the accompanying M7(R2) Addendum "Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes" have reached Step 4 of the ICH Process on 3 April 2023.
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News from EMA |
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The public consultation of the concept paper "on revision of the Guideline on clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome" ends on 31 July 2023.
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EMA publishes a reflection paper to reflect the current thinking of EMA´s CHMP on single-arm trials (SATs) that are submitted as pivotal evidence for establishing efficacy in a marketing authorisation application.
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PLM: EMA published the revised “Human Variations electronic Application Form (eAF) timeline.
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On 4 October Karl-Heinz Loebel and Dr Georg Neuwirther address these topics in the German speaking course "Product Lifecycle Management (PLM) Portal in der praktischen Nutzung".
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News from BfArM and PEI |
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The PEI informs "How the safety of medicinal products is monitored - An introduction".
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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
Quality, Safety,
CMC
+49 6221 500-652 |
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