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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

This suggests that any of the modelled changes to the regulation could lead to a decrease in the number of OMPs developed… Some of the assessed changes to the regulation could undermine the business model under which OMP?focused Maarten has significant competition law experience in a variety of sectors. About the author. References.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

4,6 Traditional Herbal Registration The Traditional Herbal Medicines Directive (Directive 2004/24/EC) is implemented in the UK by the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 and came into force on 30 April 2011. 13 Currently, over 350 herbal remedies have been granted a THR licence. 2012/1916).

Marketing 103
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New Bill could enhance UK clinical trial regulation

European Pharmaceutical Review

If achieved, this would boost the UK’s competitiveness as a leading international site for trials. Mansfield also listed the main elements of The Future Clinical Trials Bill.

Ethics 105
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The Evolution of Biosimilars from Their Beginning Until Now—And What’s Next

PM360

At Roche at the time, his job was to lead a task force which was given the objective of planning a strategy to preserve and protect the companies billion-dollar originator biologics franchises as well as build a plan which would counter the introduction and use of biosimilars. Look, competition is healthy.

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New Prescription Migraine Drugs Aren’t Resonating with Patients—Here’s How Pharma Can Boost Uptake

PM360

However, patient uptake hasn’t matched rising market competition. Among surveyed patients, nearly half (47%) couldn’t remember a single preventive migraine brand name, and the leading brand patients did recall— Topamax —is an older drug that was approved for migraine in 2004. What Marketers Can Do.

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The EU HTA regulation: a new frontier for access to innovative technologies

European Pharmaceutical Review

Article 15 proved that transparent and effective assessments of new technologies were crucial to ensure fair competition between stakeholders that operate in the EU. In addition, he was Head of the Legal Service at the European Medicines Agency from 2004 to 2012. effectiveness and therapeutic efficacy.

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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

1 However, as most biosimilars are developed by means of a complex biotechnological process in living organisms, this inevitably leads to differences between the biosimilar and the reference product. Marie Manley leads Sidley’s Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law.