What Is the European Medicines Agency?
The European Medicines Agency, or EMA, handles the scientific review and safety checks for medicines used by people and animals across the European Union. It’s been around since 1995 and makes sure that any medicine you find in the EU is safe, actually works, and meets strict quality standards.
What Is European Pharmacopoeia?
The European Pharmacopoeia (Ph. Eur.) is an official source which establishes legally binding quality standards to medicines and their ingredients in Europe. It is effective in ensuring that pharmaceutical substances, excipients and dosage forms address a uniform quality, safety and efficacy relationship and safeguard the well-being of the populace.
What Is a Development Safety Update Report (DSUR)?
A Development Safety Update Report (DSUR) is a formal safety report that is prepared by the pharmaceutical companies at the clinical development stage of an investigational medicinal product (IMP). It is aimed at ensuring that participant safety is maintained by giving an overall annual review of all available safety information to regulatory authorities.
What Is a Dossier Submission?
Dossier Submission is a systematized procedure for gathering and submitting documentations to legal bodies to seek authorization of pharmaceuticals, medical devices, or healthcare items. Such dossiers show that a product has attained the necessary standards of quality, safety, and efficacy prior to becoming marketed or distributed in a particular country or region.
What Is the Drug Information Association (DIA)?
A worldwide nonprofit organization, the Drug Information Association (DIA) is committed to improving healthcare by fostering collaboration and knowledge sharing among experts in the creation, regulation, and lifecycle management of pharmaceuticals and medical products.