556 results
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Specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products
Last updated: 12/05/2022 -
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Quality of herbal medicinal products/traditional herbal medicinal products
Last updated: 12/05/2022 -
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Fees payable to the European Medicines Agency
Last updated: 01/04/2022 -
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Use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs)
Last updated: 01/10/2021 -
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Herbal medicinal products: questions and answers
Last updated: 02/08/2021 -
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Procedures for monograph and list entry establishment
Last updated: 15/05/2021 -
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Procedure on management of proposals from interested parties for Community list entries or Community herbal monographs
Last updated: 15/04/2020 -
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Contamination of herbal medicinal products/traditional herbal medicinal products with pyrrolizidine alkaloids
Last updated: 28/02/2019 -
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Non-clinical documentation in applications for marketing authorisation / registration of well-established and traditional herbal medicinal products
Last updated: 25/02/2019 -
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News: Guidance for pharmaceutical companies to prepare for UK's withdrawal from EU
Last updated: 19/06/2018 -
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News: Revised guideline on clinical studies for Alzheimer's disease medicines
Last updated: 28/02/2018 -
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Assessment of clinical safety and efficacy in the preparation of EU herbal monographs for well-established and traditional herbal medicinal products
Last updated: 28/11/2017 -
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News: New guidelines on good manufacturing practices for advanced therapies
Last updated: 24/11/2017 -
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Development of a reflection paper on new analytical methods/technologies in the quality control of herbal medicinal products
Last updated: 31/10/2017 -
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News: Revised guideline on first-in-human clinical trials
Last updated: 25/07/2017 -
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Workshop on revising the guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicines
European Medicines Agency, London, UK, 28/03/2017, Last updated: 09/03/2017 -
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Press release: Revising the guideline on first-in-human clinical trials
Last updated: 15/11/2016 -
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News: New layout for EMA scientific guidelines
Last updated: 02/08/2016 -
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Use of herbal medicinal products containing pulegone and menthofuran
Last updated: 27/07/2016 -
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Polycyclic Aromatic Hydrocarbons in herbal medicinal products/traditional herbal medicinal products
Last updated: 29/06/2016 -
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Targeted consultation on the guideline for development of new medicinal products for the treatment of rheumatoid arthritis
European Medicines Agency, London, UK, 07/06/2016, Last updated: 09/06/2016 -
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Template for a public statement when no European Union herbal monograph is established
Last updated: 21/03/2016 -
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Herbal medicines: regulatory and scientific support
Last updated: 20/03/2016 -
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News: Guidance for the publication of clinical data
Last updated: 03/03/2016 -
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News: Consultation on revised guideline on medicines to treat Alzheimer's disease
Last updated: 01/02/2016