EDQM is founded in 1949 includes 47 member countries.its headquarters is in Strasbourg. main purpose of foundation of this council is for Protection of Human Rights & pluralist democracy & rule of law.
European Directorate for the Quality of Medicines & HealthCare (EDQM)
It is for to an access to good quality medicines and healthcare. it is very important to get EU/EDQM approval for Exporting medicine or pharmaceutical products in EU.Knowledge is a searchable database of information on a given substance or general method of analysis and also contains information such as: the monograph’s revision history; the chromatogram in pdf format; the links to the reference standard catalogue number; the trade names of some reagents, such as chromatography columns and biological kits; and access to the list of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) that have been granted for this substance.
Pharmeuropa Bio & Scientific Notes contains all the news in the biological standardisation area and scientific articles linked to the work of the European Pharmacopoeia.
Human medicines: regulatory information
This section of the website provides information on the regulation of medicines for human use in the European Union (EU). It particularly concerns the centralised procedure, where the European Medicines Agency (EMA) plays a key role.
The navigation menu contains three main sections corresponding to the key medicinal product lifecycle stages:
Regulatory information on herbal products is in a separate section, as these products are regulated differently in Europe.
For further information on EU legislation and procedures for the regulation of human medicines, see volumes 1-4 and 9-10 of the rules governing medicinal products in the EU.
Some regulatory topics span the product lifecyle. The entry pages on these topics provide an overview of the topic and direct users to relevent content in the product lifecycle sections.
- Accelerated assessment
- Adaptive pathways
- Advanced therapies
- Antimicrobial resistance
- Biosimilar medicines
- Clinical data publication
- Clinical trials
- Compassionate use
- Conditional marketing authorisation
- Data submission (Article 57)
- Ethical use of animals in medicine testing
- Falsified medicines: overview
- Generic and hybrid application
- Herbal products
- Innovation in medicines
- Medical devices
- Medicines for older people
- Marketing authorisation application
- Medicine shortages
- Medicines for use outside EU (Article 58)
- Orphan designation
- Paediatric medicines
- Parallel distribution
- Pharmacovigilance fees
- Plasma master file (PMF) certification
- Pre-authorisation guidance