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Editorial
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Author: Dr Henriette Wolf-Klein, FORUM
Institut für Management GmbH
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An online Pharma FORUM episode with Dr
Peter Bachmann took place on 19 November 2024. The focus was on the
EU pharmaceutical legislation, but ePI and variation regulation were
also addressed during the programme – a regulatory sweep, so to
speak.
At the conclusion of the programme, Dr Bachmann highlighted the
upcoming changes to variations from 1 January 2025. Type IA
variations will only be submitted as a grouping in the Annual Update
(with a few exceptions). Worksharing will also become mandatory.
... more
An update on variations (including the new Variation Regulation) will be given in German language in our seminar "Update Variations" on 24 March 2025.
Details
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News from ICH |
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The ICH M15 draft Guideline on General
Principles for Model-Informed Drug Development reached Step 2b
of the ICH Process on 6 November 2024 and entered the public
consultation period.
Details
The ICH E6(R3) Annex 2 draft Guideline on Good Clinical Practice
reached Step 2b of the ICH Process on 6 November 2024 and entered
the public consultation period.
Details
The ICH has issued a Request for Information (RFI) for a "Global
Post-Approval Chemistry, Manufacturing, and Controls (CMC)
Collaborative Assessment Cloud Solution".
Details
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News from European Commission |
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The Health Emergency Preparedness and
Response Authority (HERA) has launched the HERA Stakeholders
Hub, a secure and multifunctional platform designed to enhance
collaboration across the European pharmaceutical sector.
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News from EDQM |
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The EDQM provides further guidance to
applicants for the preparation of their dossiers to obtain a
Certificate of Suitability (CEP) for a sterile substance. This
document clarifies the conditions for acceptability of this type of
dossiers and describes the documentation to be provided.
Details
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News from EMA |
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A harmonised Technical Guidance for eCTD
Submissions in the EU has been published and comes into effect
on 1 March 2025 (version 6.0).
Details
The concept paper "on the need for revision of the addendum on
weight control in children to the guideline on clinical
evaluation of medicinal products used in weight control" can be
commented on by 28 February 2025.
Details
The guideline on the clinical requirements for non-replacement
therapy in haemophilia A and B has been adopted by CHMP on 2
December 2024.
Details
The draft guideline on "the clinical investigation of human
normal immunoglobulin for subcutaneous and/or intramuscular
administration (SCIg/IMIg)" can be commented on by 31 May 2025.
Details
The Draft to the "Data Quality Framework for EU medicines
regulation: application to Real-World Data" can be
commented on by 31 January 2025.
Details
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News from BfArM and PEI |
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The Pharmacovigilance Department of the BfArM informs
about a simplification in the submission of training material
for which there is a harmonised version in the BfArM register (in
German).
Details
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Veterinary news |
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The guideline on stability testing for
applications for variations to a marketing authorisation for
veterinary medicinal products comes into effect on 1 June 2025.
Details
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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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