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Editorial
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Author: Dr Henriette Wolf-Klein, FORUM
Institut für Management GmbH
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On 4 December 2024, the Online Pharma FORUM hosted a webcast on the topic of eSubmission with Mr Karl-Heinz Loebel, PharmaLex GmbH. Mr Loebel discussed the innovations in the areas of eCTD, PLM, process management in IRIS, the ESMP, ePI, and the EMA IRIS Dataverse.
... Read more
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News from ICH |
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The ICH Q4B(R1) guideline on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions has been adopted.
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News from European Commission |
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The European Commission adopted an implementing regulation setting out the rules for joint scientific consultations on medicinal products for human use at the Union level, under the Health Technology Assessment (HTA) Regulation.
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The Commission has launched a public consultation and a call for evidence on the EU’s legislation on medical devices and in vitro diagnostic medical devices, as part of the targeted evaluation of these rules.
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News from EDQM |
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The European Pharmacopoeia (Ph. Eur.) Supplement 11.8 is now available and will be applicable in 39 European countries as of 1 July 2025.
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News from EMA |
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EMA has published an ePI pilot report.
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If you are interested in ePI implementation, check out our German language seminar “Elektronische Produktinformation (ePI) für Humanarzneimittel” taking place on 12 March 2025, online.
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The expected start date of the strongly recommended use of the PLM Portal web-based eAF submissions to the National Competent Authorities for non-CAPs variations is now planned for February 2025. This updated timeframe is based on the latest projections by EMA’s development teams.
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EMA and HMA have updated their principles for identifying and disclosing commercially confidential information and personal data in marketing authorisation applications for human medicines.
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News from BfArM and PEI |
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The BfArM has published the German language presentation slides from the webinar “Update on Variation Regulation” held on 19 December 2024.
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The BfArM has published an updated overview form for notifications in parallel distribution pursuant to Section 29 of the AMG.
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Issue 4 – December 2024 of the Bulletin on Drug Safety has been published.
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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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