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EMA recommends 15 medicines for approval following December meeting
The EMA's human medicines committee has released its results for the December meeting, suggesting which therapies should receive marketing authorisation.
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Regulation & Legislation
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The Editors’ views: European Pharmaceutical Review’s 2020 round-up
Junior Editors of European Pharmaceutical Review, Hannah Balfour and Victoria Rees, discuss some of the most noteworthy news and announcements from this year.
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European Pharmaceutical Review Issue 6 2020
This issue focuses on whether our vaccine innovation capabilities will prepare us for future outbreaks, how Raman spectroscopy can be used to rapidly detect SARS-CoV-2 and the development of high-throughput glycoanalytics for biopharmaceuticals. Also included are articles on opportunities in the global API market and how to successfully identify defects…
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The future of RIM is cross-functional integration
By digitalising manual workflows and leveraging machine-learning algorithms to monitor events and offer data-driven insights, automation and AI can make regulatory information management (RIM) more effective and less time-consuming.
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UK Government issues guidance after allergic reactions to Pfizer COVID-19 vaccine
Following reports of the Pfizer/BioNTech COVID-19 vaccine causing anaphylaxis, the MHRA has said those prone to allergic reaction should not receive the jab.
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Health Canada authorises emergency use of Pfizer’s COVID-19 vaccine
Canada becomes the third country to approve Pfizer and BioNTech’s mRNA COVID-19 vaccine BNT162b2 for emergency use - after UK and Bahrain.
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Whitepaper: Combining rapid and EP bioburden testing
A combined testing procedure to overcome the manufacturing bottleneck caused by the time needed for compendial bioburden testing according to EP.
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Whitepaper: SARS-CoV-2 vaccines and biosafety
Upholding biosafety standards in coronavirus vaccine development and manufacturing despite the acute worldwide need.
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EMA and HMA publish joint strategy on medicine regulation for next five years
The EMA and HMA have published their joint strategy for the next five years, detailing how the regulatory network can continue the supply of safe and effective medicines.
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Fact sheet: 5 Secrets to a successful cleaning validation program
Here are five ways to ensure a successful and compliant cleaning validation program.
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Consistent data matters: lessons from the pandemic and the case for accelerating IDMP adoption
As ISO IDMP data standards gradually progress to implementation in Europe, Lise Stevens asks what bearing they might have had in the context of the global COVID-19 crisis.
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Whitepaper: Tips to improve SEC for mAbs and ADCs
Practical Tips for Monomer/Aggregate and Fragment Content Monitoring of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs).
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Whitepaper: Single-use systems underline the rising significance of extractables and leachables studies
Single-use systems come with their own extractables and leachables challenges. Although there are no formal guidelines yet, safety must be assessed.
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iPDF: Pharma analysis & QC interactive detailed workflow
Secure your Pharma analysis & QC - Take your journey through our small molecules and biologics analysis & QC regulatory compliant portfolio.
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EMA begins rolling review of Janssen’s COVID-19 vaccine candidate
The European Medicines Agency's CHMP has started a rolling review of Ad26.COV2.S, Johnson & Johnson's COVID-19 vaccine.
