Regulatory

Regulatory

Contributors in Regulatory

Regulatory

The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It is an ...

EMA

Life Sciences; Regulatory

The acronym for European Medicines Agency. The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of ...

SmPC, L or PL

Life Sciences; Regulatory

summary of product characteristics (SmPC), labelling (L) and package leaflet (PL) of medicinal products

QRD templates

Life Sciences; Regulatory

The QRD templates on the EMA website give you the official wording that has to be used in the summary of product characteristics (SmPC), labelling (L) and package leaflet (PL) of medicinal products, ...

QRD

Life Sciences; Regulatory

QRD stands for Quality Review of Documents, which is a working group associated with the Committee for Medicinal Products for Human Use (CHMP).

EDQM

Life Sciences; Regulatory

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a directorate of the Council of Europe that traces its origins and statutes to an international treaty enabling an ...