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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

4,5,6 However, these benefits are contingent on the ability to generate comprehensive, high-quality analytical and PK data packages. Since establishing a dedicated pathway for biosimilars in 2004, the EU has aimed to balance rigorous evaluation with the practicalities of fostering competition and improving patient access to biologics.

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Nitrosamine contamination in medicines: risk, regulation and reality

Hospital Pharmacy Europe

Packaging components such as nitrocellulose blister materials combined with certain inks may also promote nitrosamine formation. Article 23 and Annex I of Directive 2001/83/EC and Article 16 of Regulation (EC) No 726/2004. 11 Evaluating the risk: what do we really know about nitrosamines? Acad Emerg Med 2014;21:704–11.

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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Food and Drug Administration (FDA), 2004. Figure 2 outlines four main topics where PAT can play an important role: (1) Industry 4.0

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Regulating decentralised manufacturing in the UK – a legal perspective

European Pharmaceutical Review

In the EU, the EU pharmaceutical package of reform 5 includes a proposed new Directive, 6 which will replace the current Medicines Directive (2001/83/EC). Available from: [link] Human Medicines Regulations 2012 and Medicines for Human Use (Clinical Trials) Regulations 2004. Under the Human Tissue Act 2004.

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Life sciences VC Omega Funds closes $647m funding round

Pharmaceutical Technology

EU’s Pharma Package falls short of Europe’s goal of global competitiveness Why can’t the US figure out weight loss drug prices? Ross Law July 21, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook According to Omega Funds, it has raised $2.5bn since launching in 2004.

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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

It is too early to say because we have not seen the whole package of measures yet. THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION; 2004. One of the key priorities of the EU’s strategy is to encourage innovation to solve unmet medical needs. THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION; 2006.

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FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements

The FDA Law Blog

All packaged foods served or sold on transportation carriers (e.g., 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., labeling of major food allergens in bulk foods, dietary supplements, protein-free ingredients, and foods produced through genetic engineering); and.