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Summary: AMNOG 2023 & EU-HTA
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Author: Dr Henriette Wolf-Klein, FORUM
Institut für Management GmbH
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On 26 January 2023, the online meeting "AMNOG 2023 & EU-HTA" took place. Marcus Guardian, Chief Operating Officer of the EUnetHTA Secretariat went into the details of the roadmap to the launch of EU-HTA in 2025. A large part of the EUnetHTA21 deliverables have already been published, accepted by the EU Commission and now forwarded to the HTA Coordination Group. The coordination group can now adopt the guidelines, but also modify them.
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News from the European Commission |
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A Commission decision adopted on 26 January will contribute to improve the quality of medicines in the EU. It allows trusting on the quality of active substances produced in Canada.
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On 23 January 2023 the European Commission published the "EU survey on the implementation of the Clinical Trial Regulation".
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If you are new to the field of clinical trials, the comprehensive two-day introductory course "Clinical Trials in a Nutshell: The European Legal Framework" offers an ideal start on 23 and 24 March.
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News from the ICH |
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The ICH Q9(R1) Guideline on Quality Risk Management has reached Step 4 of the ICH Process on 18 January 2023. This Guideline is intended to provide guidance on the principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.
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A Step 2 Informational Presentation has been developed by the M13 Expert Working Group, in follow up to the ICH M13A draft Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms reaching Step 2b of the ICH Process in December 2022.
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News from the EU Commission |
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The EU Commission has published an updated rolling plan for the implementation of the HTA regulation.
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News from the EMA |
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From 31.01.2023, applications for new clinical trials must be submitted centrally via the Clinical Trials Information System (CTIS).
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EMA published a Risk Mitigation Plan with regard to the Clinical Trials Information System.
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The Product Lifecycle Management Portal – Human Variations eAF Guide to navigation (Draft)Version 1.2 is published.
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You may be interested in the online seminar "Updates on EMA Electronic Application Management" on 26 April, which addresses the impact of ISO IDMP on regulatory processes (PLM, CTIS, IRIS).
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News from BfArM and PEI |
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The Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz (Federal Health Bulletin - Health Research - Health Protection) is a monthly health science journal whose editorial office is located at the Robert Koch Institute. The editors are the Federal Institute for Drugs and Medical Devices (BfArM), the Paul Ehrlich Institute (PEI), the Federal Center for Health Education (BZgA) and the Robert Koch Institute (RKI).
Volume 66, Issues 2, February 2023 with a focus on "Technical, Legal and Ethical Framework Conditions of Digitisation in Healthcare - Highlights of an Accelerated Development" has been recently published.
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News from the EDQM |
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Two texts dealing with pharmaceutical technology, one revised and one new, have recently been published in Pharmeuropa 35.1 for public consultation.The first is the Revision of the harmonised general chapter 2.9.3. "Dissolution of tablets and capsules", the second a new general chapter 2.9.55. "Characterisation of powder behaviour during compression".
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Veterinary news |
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The Draft Guideline "on quality, safety and efficacy of veterinary medicinal products specifically designed for phage therapy" can be can be commented until 31 Mai 2023.
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From 2023, all EU Member States are obliged under Article 57 of the European Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) to record the quantities of antimicrobial medicinal products (prescription, use or supply) used in all cattle, pigs, chickens and turkeys and to notify them to the European Medicines Agency (EMA) the following year.
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The FORUM seminar "Pharmacovigilance for veterinary medicinal products - focus on quality management system" informs about the design of the QMS, implementation of SOPs in critical PV areas and makes your system "vGVP-inspection ready".
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Kind regards,
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Dr Tatjana Mende
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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