The European Medicines Agency (EMA) provides regulatory and scientific support to help acadmeics develop medicines
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Quality, preclinical and clinical aspects of Gene Therapy medicinal products
Published by EMA
Non-ClinicalQualityclinicalGenetically Modified Cellsomatic cellAdvanced TherapyGene TherapyCell TherapyGuide for the development and evaluation of Gene Therapy Medicinal Products (GTMPs) intended for use in humans and presented for Marketing Authorisation Application (MAA). Its focus is on the quality, Safety and efficacy requirements of GTMPs.
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Recommendation paper on decentralised elements in clinical trials
Published by EMA
Decentralised Clinical TrialsRecommendations that aim to facilitate the conduct of decentralised clinical trials (DCTs) while safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected
View this resource Bookmark this resourceComputerised systems, electronic data, validation, audit trail, user management, security, electronic clinical outcome assessment (eCOA), interactive response technology (IRT), case report form (CRF), electronic signatures, artificial intelligence (AI)
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European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance
Published by EMA
protocol assistanceScientific AdviceThis guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have.
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Predictive biomarker-based assay development in the context of drug development and lifecycle
Published by EMA
EMAPredictive BiomarkersThe proposed concept paper is intended to be developed into a guideline which will replace the reflection paper on co-development of pharmacogenomic biomarkers and assays in the context of drug development. The guideline will provide recommendations on the interface between predictive biomarker-based assays including CDx, and the development and lifecycle of a medicine.
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Active substance
Published by EMA
Active SubstanceComparability and BiosimilarityPlasma-Derived Medicinal ProductPlasma Master FileVaccineThe European Medicines Agency’s scientific guidelines on biological medicinal products help medicine developers prepare marketing authorisation applications for human medicines.
View this resource Bookmark this resourceThe European Medicines Agency’s scientific guidelines on biological medicinal products help medicine developers prepare marketing authorisation applications for human medicines.
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Qualification of novel methodologies for drug development: guidance to applicants (EMA/CHMP/SAWP/72894/2008). 2013
Published by EMA
Scientific AdviceEMA QualificationThe EMA Qualification process is a new, voluntary, scientific pathway leading to either a CHMP Qualification opinion or a qualification advice on innovative methods or drug development tools
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