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Harald Enzmann

As seen in: Nature, The Lancet, Future Medicine
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Articles by Harald Enzmann

Analysis of a decade of post-authorisation studies for medicines approved by the EMA

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By Caroline Voltz-Girolt, Carla Torre, Bruno Sepodes, Harald Enzmann, Guillem Wetherell Mateu
| Nature Verified
Medicines are granted marketing authorisation (MA) by the European Medicines Agency (EMA) based on an assessment that they have a positive benefit–risk balance, but additional data on quality, safety or efficacy may still be needed post-authorisation in some cases. These requirements are addressed through post-authorisation study measures (PAMs), which include studies or activities requested from Marketing Authorisation Holders (MAHs) by the EMA. Enjoying our latest content?
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The European Medicines Agency's EU conditional marketing authorisations for COVID-19 vaccines

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By Marco Cavaleri, European Medicines Agency, Harald Enzmann, Sabine Straus
| The Lancet Verified
Few medicines are awaited as eagerly as COVID-19 vaccines. Extraordinary efforts by scientists, regulators, and developers enabled the European Medicines Agency (EMA) to recommend the first EU conditional marketing authorisation (CMA) for the BioNTech COVID-19 mRNA vaccine (nucleoside-modified) BNT162b2 (Comirnaty) some 9 months after the COVID-19 pandemic was declared.
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Added therapeutic benefit and drug licensing

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By Hans-Georg Eichler, Harald Enzmann, Guido Rasi
| Nature Verified
COMMENT 11 April 2019 One aspect of the ongoing debate about drug pricing is the added therapeutic benefit of new drugs compared with existing — and potentially cheaper — therapies. Here, we discuss the merits and pitfalls of proposals that are being discussed with regard to the role of regulatory agencies in establishing added therapeutic benefit. Harald Enzmann & European Medicines Agency (EMA), Amsterdam, Netherlands; Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.
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The new EU regulation on in vitro diagnostics: potential issues at the interface of medicines and companion diagnostics

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By Ralf Meyer, Karl Broich, Harald Enzmann
| Future Medicine Verified
The new European regulation for in vitro diagnostics (IVD) divides the certification of IVD including companion diagnostics (CDx) by notified bodies (NB) from the market authorization of medicines. With the new regulation, CDx will require conformity assessment which is expected to include clinical evidence by NB. This is a significant change from the current situation: until now most IVD have been certified based on their manufacturers’ assessment.
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