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Editorial
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Author: Dr Henriette Wolf-Klein, FORUM Institut
für Management GmbH
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On 25 June 2024, an episode of the Online Pharma FORUM focused on "Approval Strategies in Europe," featuring Dr Ulrich Granzer from Granzer Regulatory Consulting & Services. The webcast addressed submission options within the EU, with comparisons to the US, and highlighted recent updates to regulatory frameworks in Europe.
... more
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News from ICH |
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The ICH has released new introductory training videos for ICH E8(R1) and updated training materials for ICH Q9(R1) on Quality Risk Management.
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News from European Commission |
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The European Commission launched an online public consultation on the draft implementing act on joint scientific consultations on medical devices and in vitro diagnostic medical devices at Union level under the Health Technology Assessment (HTA) Regulation.
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News from EMA |
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EMA announced that the non-Centrally Authorised Products (non-CAPs) data are now available in the Human variation web-based eAF within the Product Lifecycle Management (PLM) Portal.
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EMA published the interim report "Proof-of-concept pilot on using data from clinical studies in medicines evaluation". It contains the experience gained with submission and analysis of patient-level data from clinical studies from September 2022 to December 2023.
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The Concept paper "on clinical evaluation of therapeutic radiopharmaceuticals in oncology" can be commented on by 31 January 2025.
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News from CMDh |
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Guidance is available on the implementation of the amended Variations Regulation (EU) 2024/1701 for variation applications implemented and submitted from 1 January 2025.
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An update on variations (including the new Variation Regulation) will be given in German language in our seminar "Variations für Praktiker" on 28 November. Registration is still possible.
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News from BfArM and PEI |
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The annual meeting of representatives of the Paul Ehrlich Institute and the Pharma Deutschland Association took place on 30 October.
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Veterinary news |
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The guideline on quality data requirements for applications for biological veterinary medicinal products intended for limited markets will come into effect on 1 May 2025.
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The guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 will come into effect on 1 May 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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