Blog & Article
- 20th November 2025
Journal Articles
Journal Article
The EU legislation for substances of human origin (SoHOs) has been revised, bringing blood products, tissues and cells under one regulation.
Journal Article
Combination-product growth has surged globally as both physicians and patients request fewer invasive procedures in favor of user-friendly treatment delivery options.
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Advances in the cancer treatment space have renewed hope for breakthroughs with personalized cancer vaccines (often also called personalized immunotherapies). More recently, there have been promising results in a number of areas, including pancreatic cancer, melanoma, and non-small cell lung cancer (NSCLC).{1} According to analysts, significant growth is expected for cancer vaccines, with one report noting that the global market for cancer vaccines should grow from $10.21 billion in 2023 to $30.16 billion by the end of 2033.{2}
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The steps to commercialization readiness are complex, multi-faceted and often left too late in the launch strategy of a pharmaceutical product. This can be particularly problematic in Europe where the diversity of national legislation can make supply chain logistics very challenging. Among the issues faced, particularly for non-EU countries, are defining the product’s logistics, identifying stakeholders who will be involved in the supply chain in Europe, and ensuring that all these individuals are ready to assume their roles soon after the product’s approval (Marketing Authorization) with the relevant Licences and Quality Technical agreements in place.
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One of the biggest challenges when launching a product in the EU is understanding the complex regulatory landscape. Besides the overarching European legislation, each country has its own national requirements for the supply of medicinal products.
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The advancement of bioinformatics has allowed for an explosion in the field of precision medicine over the last decade. There are more and more drugs that address a specific subset of patients, not least within oncology. In parallel, the centralisation process of determining clinical benefit is approaching fast, and Joint Clinical Assessment (JCA) as part of EU HTA regulation will be implemented for new oncologics and ATMPs (advanced therapy medicinal products) in January 2025. As several emerging therapies could be treatment game-changers, quick patient access without delay is of outermost importance.
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Targeted medicines have already had a dramatic effect on treatment for many patients, with advances in technology instrumental in helping to ensure they reach individuals that will benefit from them.
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While regulatory authorities are increasingly adopting reliance programs to asses applications, few offer the opportunity to take advantage of simultaneous assessment and approval timelines across borders and jurisdictions.
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The electronic Common Technical Document (eCTD) is 16 years old, approved by the International Council on Harmonisation (ICH) to Step 4 in 2008. It’s old enough to drive a car in the US. It’s had some small changes over the years but is still pretty much the same as it was in the George W. Bush era. It’s had a huge impact on the speed and accuracy of regulatory submissions for pharma … but it could be better. That same year, the US Food and Drug Administration (FDA) started looking at a next-generation submission format, which would become eCTD 4.0. That standard
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Combination products are integral to the healthcare system and play an increasingly important role in patient safety and medicinal usability, enhancing therapeutic benefits and improving outcomes.
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Technology transfer is a sophisticated and complex undertaking that requires careful planning to ensure successful transition and regulatory compliance.
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The concept of ‘vigilance’, as it applies to medical devices, relates to the identification, reporting and trending of serious incidents as well as any corrective actions related to safety. It is distinct but related to the supporting post-market surveillance processes which focus on the monitoring of information to provide periodic confirmation that the benefit of a medical device outweighs the risk. These are not new concepts, however the requirements for vigilance and postmarket surveillance were not clearly delineated or articulated within the original Medical Device Directive (MDD) or In Vitro Diagnostics Directive (IVDD).