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EMA Good clinical practice (GCP) inspection procedures
The Good Clinical Practice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines...
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Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics
This guidance document aims to provide interested parties with appropriate guidance on procedural aspects to facilitate the consultation procedure to the European Medicines Agency (EMA) by notified...
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Global regulators agree on key principles on adapting vaccines to tackle virus variants
News 01/07/2022 On 30 June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve during a workshop...
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Draft report on the development of a harmonised approach to exposure assessment methodologies for residues from veterinary medicinal products, feed additives and pesticides in food of animal origin
In 2020, the European Commission (EC) requested EMA and European Food Safety Authority (EFSA) for advice for the development of a harmonised approach on exposure assessment methodologies for residues...
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How to Leverage EMA’s ATMP Classification
Advanced therapy medicinal products (ATMPs) have emerged as ground-breaking therapies for rare diseases and other conditions with unmet clinical needs. As of 2022, sixteen ATMPs have been approved by...
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EMA Procedural guidance for variant strain(s) update to vaccines intended for protection against Human coronavirus
8 June 2022 EMA/175959/2021 Rev.2 Human Medicines Division Regulatory and procedural requirements Introduction In order to ensure the continued effectiveness of authorised COVID-19 vaccines, it may...
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EMA Checklist for annual updates for parallel distribution - Draft Guidance
22/06/2022 EMA/405782/2020 Rev. 3 Human Medicines Division The European Medicines Agency (hereinafter 'the Agency') asks its applicants to use this checklist in advance of submission of an annual...
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Maximising on Scientific Advice Procedures in Europe
A unique opportunity to interact with medicine regulators in Europe Are you considering requesting scientific advice in Europe? We can help you navigate the various procedures within the European...
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Advice on the designation of antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans - in relation to implementing measures under Article 37(5) of Regulation
Regulatory and Procedural Guideline May 2022 EMA/CVMP/678496/2021-rev Introduction “According to Article 37(5) of Regulation (EU) 2019/6 (‘the Regulation’), the European Commission shall adopt...
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Validation checklist for initial marketing authorisation applications - biologicals other than immunologicals (applicable to submissions under Regulation (EU) 2019/6)
JUNE 2022 EMA/278419/2022-Rev.1 This validation checklist is used by the Agency to validate initial marketing authorization applications for pharmaceuticals and applicants should use it as a means to...