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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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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

He focuses his practice on EU regulatory affairs, litigation and competition law issues affecting the life sciences sector in Europe. In addition to advising on EU life sciences matters, Maarten also handles competition litigation at the EU and national levels. Maarten has significant competition law experience in a variety of sectors.

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Pharma responds to proposed EU pharmaceutical legislation reform

European Pharmaceutical Review

Pinsent Masons Charlotte Weekes, Senior Associate at Pinsent Masons shared with EPR : “The Commission’s ambitious pharma legislation review is the first significant review of the European system since 2004.” “It

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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. Benefits of The Future Clinical Trials Bill Chiefly, the Bill’s goal is to increase patient participation and overall, ensure clinical trials have the highest levels of safety while enabling greater regulatory pragmatism, the author explained.

Ethics 105
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Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Pharmaceutical Technology

The revision process is reviving old conflicts in the pharma industry over fair and affordable access to medicines versus Europe’s status as a competitive home for pharma innovation. EU competitiveness Moll said the legislation revisions should instead be used to make Europe more attractive to pharma companies.

Pharma 64
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A glance back to Pharma Integrates, London 2022 – part ii

pharmaphorum

GIRFT and competition He went on: “Improvement needs competition – everything else is a proxy; it doesn’t work well. When Milburn and Blair introduced competition in 2004-2008 it did start to make a difference.” Highly unlikely.”

Pharma 76
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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

She has experience on issues arising during the lifecycle of medicinal products, including optimisation of IP regulatory rights, advertising, product liability, competition and market access issues. The Impact of Biosimilar Competition in Europe, IQVIA, December 2021. Directive 2001/83 (as amended). EMA Biosimilars Q&A.