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Editorial
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Author Verena Planitz, FORUM Institut für Management GmbH
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In the latest episode of the PharmaFORUM Webcast International on 9 July 2024, key updates and procedures regarding China′s regulatory landscape were presented by Jenny Zhang (CSL Vifor, China). Enclosed is a summary of essential points regarding clinical trial applications (CTA), pre-submission activities, and marketing authorization applications (MAA) to consider.
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News from ICH |
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TThe ICH M12 guideline on drug interaction studies provides recommendations to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical pharmacokinetic drug-drug interaction (DDI) studies during the development of a therapeutic product. It comes into effect on 30 November 2024. On the date of its coming into effect, ICH M12 will supersede the EMA Guideline on the investigation of drug interactions – Revision 1.
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News from European Commission |
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A new version of the EU eCTD M1 Specification is now published. The version 3.1 sees the introduction of a new annex detailing the list of accepted file formats.
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From 26 June to 24 July 2024 the feedback period is open for the draft implementing regulation on procedural rules for how the member state coordination group on health technology assessment (HTA) and the European Commission will work with the European Medicines Agency (EMA). This includes sharing information about joint clinical assessments of medicines and medical devices, as well as joint scientific consultations on these products.
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Dr Willi Schnorpfeil will give a talk on “Access to gene therapies in DE: Challenges of the EU HTA” during the training “Market Access ATMPs” on 26th November 2024.
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The European Commission has published guidance on the clinical evaluation of orphan medical devices.
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The amendments of the Variation Regulation are published in the Official Journal of the European Union.
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On day II of the seminar “CMC Management in Regulatory Affairs” from 12th-13th November 2024 our three experts will inform you about the relevant details on the management of post-approval changes.
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News from EMA |
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The newest information on CTIS was published in the CTIS newsflash on 14 June 2024.
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The EMA/CMDh provides an update of Appendix 1 for nitrosamines.
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You will receive an update on the topic "Impurities in pharmaceuticals - focus on nitrosamines" on 14 November 2024.
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News from BfArM |
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The bulletin on drug safety issued 2/2024 has been published by the BfArM and PEI.
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Veterinary news |
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The QRD guidance on the use of approved pictograms on the packaging of veterinary medicinal products authorised via the centralised, mutual recognition and decentralised procedures has been updated.
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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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