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

European Pharmaceutical Review

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 10,12 The THR scheme is also limited to products used for oral or external use and/or inhalation.

Marketing 103
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European Commission revokes marketing authorisation for Novartis’ crizanlizumab

European Pharmaceutical Review

Novartis said the decision to revoke the authorisation was based on a review of crizanlizumab under Article 20 of Regulation (EC) No 726/2004. However, the STAND results did not suggest new safety concerns with crizanlizumab.

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EU proposes new blood, tissues and cells Regulation

European Pharmaceutical Review

The European Commission (EC) has issued a draft proposal for a new EU Regulation on blood, tissues and cells (BTC) to help increase the safety and quality of substances of human origin (SoHO). The EC noted that the EDQM’s standards “will now become the primary means to meet the EU standards of quality and safety for BTC.”.

Safety 116
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Pharmaceutical industry: 2023 in retrospect

European Pharmaceutical Review

During 2023, there were five revisions to the European Medicines Agency ’s (EMA’s) Questions and Answers (Q&As) for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products. These changes are summarised in Table 1.

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New Bill could enhance UK clinical trial regulation

European Pharmaceutical Review

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. If achieved, this would boost the UK’s competitiveness as a leading international site for trials.

Ethics 105
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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. This is reflected in the legal basis for biosimilars under Article 6 of Regulation 726/2004 and Article 10(4) of Directive 2001/83 (as amended by Directive 2004/27).

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Preparing for stricter standards on substances of human origin

European Pharmaceutical Review

Covered SoHO activities are “action[s], or series of actions, that [have] a direct impact on safety, quality or efficacy of SoHOs.” This will enable better monitoring of the safety and quality of these products, but it may also require additional investments in IT infrastructure.

Safety 75