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Search results (8)
ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Step 2b
English (EN) (970.26 KB - PDF)
ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 5
English (EN) (1.13 MB - PDF)
Draft ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b
This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing ICH Quality guidelines, this guideline provides clarification on CM concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug products.
This guideline applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. The principles described in this guideline may also apply to other biological/biotechnological entities.
It is applicable to CM for new products (e.g., new drugs, generic drugs, biosimilars) and the conversion of batch manufacturing to CM for existing products.
English (EN) (1.8 MB - PDF)
Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells - Revision 1
English (EN) (495.66 KB - PDF)
Draft toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications
This guidance summarises scientific and regulatory approaches that developers of medicines supported by EMA’s PRIME scheme can use to generate robust quality data for an EU marketing authorisation application, to enable patients to benefit from these therapies as early as possible.
It aims to address common challenges with meeting quality and manufacturing development data requirements during development and at the time of marketing authorisation application.
It covers medicines containing chemical, biological or biotechnologically derived substances and advanced therapy medicinal products (ATMPs).
The completed comments form should be sent to qwp@ema.europa.eu.
English (EN) (912.2 KB - PDF)
Concept paper on preparation of a guideline on the evaluation of medicinal products indicated for the treatment and prophylaxis of respiratory syncytial virus (RSV) infection - First version
This concept paper proposes the development of a guideline on the clinical evaluation of medicinal products indicated for the treatment and prophylaxis of respiratory syncytial virus (RSV) infections for which there is no regulatory guidance currently available in the EU.
English (EN) (94.71 KB - PDF)
Concept paper on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products
Currently, there is limited information on the utilisation of a genomic biomarker during follow up (post marketing) or on the effect of labelling with genomic information. Therefore, guidance is needed on the evaluation of genomic influences during pharmacovigilance activities in order to inform and improve clinical use of specific treatments. It is considered necessary to produce a guideline on the evaluation of pharmacogenomic specific issues in the conduct of pharmacovigilance. Document has republished with revised consultation dates.
English (EN) (65.2 KB - PDF)
Consultation on qualification opinion ILSI / HESI submission of novel renal biomarkers for toxicity
The European Medicines Agency qualification process is a new, voluntary, scientific pathway leading to either a CHMP opinion or a Scientific Advice on innovative methods or drug development tools. It includes qualification of biomarkers developed by consortia, networks, public/private partnerships, learned societies or pharmaceutical industry for a specific intended use in pharmaceuticals R&D.
English (EN) (709.29 KB - PDF)