Conditional Marketing Authorization

Published by IRDiRC

Regulatory Affairs Marketing Authorisation Conditional Marketing Authorisation

The CMA allows a fast access to medicines for patients, which fulfil an unmet medical need

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EMA Marketing Authorization (MA) with conditions

Published by IRDiRC

EMA Conditional Marketing Authorisation Safety Data Efficacy Data Regulatory Affairs Marketing Authorisation

A marketing authorisation may be granted with certain conditions in order to ensure the collection of additional Safety and or efficacy data.

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Core Outcome Measures in Effectiveness Trials

Published by IRDiRC

Effectiveness Trial Outcome Measure Clinical Trial Design Clinical Development Research and Drug Development Endpoint COMET

The COMET (Core Outcome Measures in Effectiveness Trials) Initiative brings together people interested in the development and application of agreed standardised sets of outcomes, known as ‘core outcome sets’ (COS). These sets represent the minimum that should be measured and reported in all clinical trials of a specific condition, and are also suitable for use in clinical audit or research other than randomised trials.

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BBMRI-ERIC – European research infrastructure for biobanking.

Published by IRDiRC

European Union Infrastructure Research and Drug Development Biobank

BBMRI-ERIC is a European research infrastructure for biobanking. We bring together all the main players from the biobanking field – researchers, biobankers, industry, and patients – to boost biomedical research

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Certification for advanced therapy medicinal products

Published by IRDiRC

Certification Regulatory Affairs Early Access Support Advanced Therapy Committee for Advanced Therapies ATMP Certification

The European Medicines Agency’s Committee for Advanced Therapies (CAT) provides a certification procedure for advanced therapy medicinal products (ATMPs) under development by micro-, small- and medium-sized enterprises (SMEs) only

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Magisterial hospital preparations – hospital exemptions

Published by IRDiRC

Regulatory Affairs Early Access Support Advanced Therapy Hospital Exemption ATMPs

Article 28 of the ATMP Regulation also empowers Member States to permit the manufacturing and use of certain non- routine produced advanced therapies that have not been authorised by the Commission under certain conditions (so-called “Hospital Exemption”) outside the scope of the Medicinal Product Directive 2001/23.

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