EDQM CO

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a branch of the Council of Europe responsible for establishing quality standards and ensuring the quality, safety, and efficacy of medicines and healthcare products in Europe. EDQM plays a significant role in safeguarding public health by setting standards and providing guidance on the quality of pharmaceuticals and related substances. EDQM was established in 1964 as a response to the thalidomide tragedy to ensure the quality and safety of pharmaceutical products in Europe. Let us now examine core attributes of the EDQM in a formal context:

Pharmacopoeias: EDQM publishes and maintains the European Pharmacopoeia (Ph. Eur.), which contains quality standards and monographs for pharmaceutical substances and dosage forms used in Europe. It is an official reference work in the European Union (EU) and numerous other countries.
Quality Standards: The European Pharmacopoeia sets quality standards for the identification, purity, strength, and quality of active substances, excipients, and finished pharmaceutical products. Compliance with these standards is a requirement for marketing authorization in Europe.
Certification: EDQM provides certification for reference standards, which are used by laboratories to ensure the accuracy of their testing methods and results. These reference standards are essential for quality control and analytical testing.
Pharmacovigilance: It monitors and evaluates the safety of medicines in Europe through its Pharmacovigilance Program.
International Impact: While EDQM primarily serves European countries, its standards and guidelines often influence and align with global pharmacopeial standards, contributing to global harmonization efforts.

The European Directorate for the Quality of Medicines & HealthCare plays a crucial role in ensuring the quality, safety, and efficacy of medicines and healthcare products in Europe. Its standards and activities are essential for the pharmaceutical industry, regulatory agencies, and healthcare practitioners to maintain high standards of healthcare and public safety. At FGT, we are committed to facilitating the acquisition of EDQM reference standards at a cost-effective rate. However, the availability of these standards may be influenced by the manufacturer’s method of analysis. It’s important to note that we can provide either USP or EDQM standards based on client requirements.