A Safety Data Exchange Agreement is a legal written contract which ensures that all safety data regarding a medicinal product makes its way quickly and reliably back to the marketing authorisation holder so that they may fulfil their legal obligations
Latest Glossary Definitions
Target product profile (TPP)
A TPP is a format for a summary of a drug development program described in terms of labeling concepts.
Committee for Advanced Therapy (CAT)
The Committee for Advanced Therapies (CAT) is the European Medicines Agency's (EMA) committee responsible for assessing the quality, safety and efficacy of advanced therapy medicinal products (ATMPs) and following scientific developments in the field.
Ethics Committee (EC)
The ethics committee, according to Directive 2001/20/EC, is an independent body in a member state of the
Environmental Risk Assessment (ERA)
In accordance with Article 8(3) of Directive 2001/83/EC, as amended, the evaluation of the potential environmental risks posed by medicinal products should be submitted, their environmental impact should be assessed and, on a case-by-case basis, specific arrangements to limit the impact should be
International Committee for Harmonisation (ICH)
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.
Somatic-Cell Therapy medicinal Products (sCTP)
These contain cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same essential functions in the body. They can be used to cure, diagnose or prevent diseases.
Tissue Engineered Product (TEP)
A human tissue-engineered product (hTEP) means any autologous or allogeneic product which:
• contains, consists of, or results in engineered human cells or tissues; and
