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EMA revises guidance on nitrosamine impurities

European Pharmaceutical Review

The assessment report of the Committee for Medicinal Products for Human Use (CHMP)’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products offers guidance and recommendations on mitigation and prevention of nitrosamine-contaminated human medicinal products.

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EU proposes new blood, tissues and cells Regulation

European Pharmaceutical Review

The new Regulation will replace the rules for safety and quality set out in Directives 2002/98/EC for blood and blood components and 2004/23/EC for tissues and cells, in addition to their implementing acts. .

Safety 116
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Realising milestones with gene therapy for SMA

European Pharmaceutical Review

Three SMN-enhancing treatments for the condition are approved by the US Food and Drug Administration (FDA) 2 , however there is no cure for SMA at present. This is often called an ‘SMN-based’ or ‘SMN-enhancing’ approach.

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

Pharmaceutical Technology

The products that are authorised in EU are largely the same as other regions,” argued European Commission Directorate-General for Health and Food Safety Florian Schmidt, during the same online event. But others do not accept that the EU is less competitive for the pharma industry than North America and Asia. You can compare timelines.

Pharma 64
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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

Marie advises clients in the pharmaceutical, biotechnology, medical devices, chemicals, cosmetics and food sectors in proceedings before both national and European courts and the regulatory agencies in the UK and across Europe. Chris was named a ‘Rising Star’ in the 2022 Legal 500 Rankings for Life Sciences and Healthcare.

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

European Pharmaceutical Review

In addition, he was Head of the Legal Service at the European Medicines Agency from 2004 to 2012. He joined BonelliErede in 2018 and specialises in regulatory and compliance matters related to pharmaceuticals, medical devices, medical technology, biotechnology, food, cosmetics and novel products.

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Nitrosamine drug substance-related impurities (NDSRIs)

European Pharmaceutical Review

The US Food and Drug Administration (FDA) requires that manufacturers establish whether nitrosamines, including NDSRIs, could be present in active pharmaceutical ingredients (APIs) and drug products, using the “three-step mitigation strategy described in the agency’s guidance”. About the author. Nitrosamine Imp -Q&A-Mar-22.pdf.