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Fingolimod product-specific bioequivalence guidance (updated)
Last updated: 09/08/2019 -
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Quality of medicines questions and answers: Part 1 (updated)
Last updated: 05/08/2019 -
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ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk (updated)
Last updated: 30/07/2019 -
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Clinical pharmacology and pharmacokinetics: questions and answers
Last updated: 15/05/2019 -
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ICH E8 General considerations for clinical studies
Last updated: 10/05/2019 -
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ICH Q3D Elemental impurities
Last updated: 29/03/2019 -
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Investigation of subgroups in confirmatory clinical trials
Last updated: 14/03/2019 -
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Sterilisation of the medicinal product, active substance, excipient and primary container
Last updated: 08/03/2019 -
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Octreotide acetate product-specific bioequivalence guidance
Last updated: 08/02/2019 -
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Clinical investigation of medicinal products for the treatment of gout
Last updated: 08/02/2019 -
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Core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg)
Last updated: 22/01/2019 -
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Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)
Last updated: 22/01/2019 -
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ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management
Last updated: 18/01/2019 -
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Evaluation of medicinal products indicated for treatment of bacterial infections
Last updated: 14/01/2019 -
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Clinical development of fixed combination medicinal products
Last updated: 17/12/2018 -
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Quality and equivalence of topical products
Last updated: 14/12/2018 -
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Aliskiren product-specific bioequivalence guidance
Last updated: 13/12/2018 -
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Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation
Last updated: 13/12/2018 -
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Quality of medicines questions and answers: Part 2
Last updated: 11/12/2018 -
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Environmental risk assessment of medicinal products for human use
Last updated: 30/11/2018 -
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Quality of water for pharmaceutical use
Last updated: 15/11/2018 -
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Multistakeholder workshop to launch consultation on European Medicines Agency (EMA) human regulatory science to 2025
European Medicines Agency, London, UK, 24/10/2018, Last updated: 08/11/2018 -
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Questions and answers on bovine spongiform encephalopathies (BSE) and vaccines
Last updated: 08/11/2018 -
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Questions and answers on the Haemagglutination Inhibition (HI) test for qualification of influenza vaccine (inactivated) seed preparations
Last updated: 08/11/2018 -
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Quality aspects included in the product information for vaccines for human use
Last updated: 07/11/2018