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The online conference "Biosimilars 2023 – the Aut idem rules" took place on 5 July 2023.
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Author: Dr Henriette Wolf-Klein, FORUM
Institut für Management GmbH
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| The starting point of the event was the Federal Joint Committee (G-BA) decision of 15 June 2023, which regulated the interchangeability of medically prescribed preparations of finished medicinal products with biotechnologically produced active ingredients in pharmacies and thus gave the starting signal for biosimilar aut idem.
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News from the ICH |
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The ICH E6(R3) draft Guideline on "Good Clinical Practice" reached Step 2b of the ICH Process in May 2023 and subsequently entered the consultation period.
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News from HMA |
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EMA and the Heads of Medicines Agencies (HMA) are running a pilot project to enable clinical-oncology scientists to participate in medicine regulation. The pilot focuses on scientific advice and marketing authorisation assessments for human medicines.
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News from EMA |
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The Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus will come into effect 1 January 2024.
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EMA and EU Commission have published the "Guidance on Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period".
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A webcast series consisting of the parts EU-HTA legislation, EU-HTA dossier compilation and national EU-HTA preparation in France, Italy, Spain and the UK will also cover this Guidance.
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EMA publishes a report on "real-world evidence framework to support EU regulatory decision-making".
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Veterinary news |
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The VICH GL18(R2) impurities: residual solvents in new veterinary medicinal products, active substances and excipients will come into effect in April 2024.
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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
Quality, Safety,
CMC
+49 6221 500-652 |
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