All change at the European Pharmacopoeia, the Strasbourg-based organisation responsible for European pharmaceutical quality standards
Arthur Rogers/Strasbourg, France
All change at the European Pharmacopoeia, the Strasbourg-based organisation responsible for European pharmaceutical quality standards, and its parent body, the European Directorate for the Quality of Medicines & HealthCare (EDQM).
A new 36.3 million euro (?24.6) headquarters incorporating 1800 m2 of laboratory space was inaugurated on 20 March, offering state-of-the-art accommodation and technical facilities for the pharmacopoeia’s 160 personnel, of whom half are scientists.
Conformity with Strasbourg standards covering quality, nature, composition and concentration is a mandatory requirement for authorisation of a medication in Britain and 35 other countries.
The Pharmacopoeia operates mostly in a triangular arrangement with the European Union and its London-based European Medicines Agency (EMEA).
’The EMEA evaluates new medicines for their safety and efficacy, the EDQM is responsible for standardisation, and the European Commission handles legislative regulation of the pharmaceutical sector,’ explained Agn?s Artiges, who retires as EDQM’s director in June.
In non-EU states party to the 1964 European Pharmacopoeia Convention, authorisations are granted according to national legislation.
Strasbourg standards cover all medicines regardless of origin, whether chemical, biological or herbal.
The Pharmacopoeia itself describes a wide range of active substances, excipients and even materials used in containers, and includes more than 2000 monographs on preparations and substances, nearly 300 general methods of analysis, and 2400 reagents.
EDQM responsibilities nowadays extend to organs and substances of human origin, blood and blood derivatives.
’Sooner or later, standardisation of quality control will be put in the Pharmacopoeia for nano-particles which may be used in pharmaceuticals,’ Artiges told Chemistry World.
’New medicines using nano-technology will be considered firstly by the EMEA, and when the time is right, we will prepare a new chapter of the Pharmacopoeia, for quality control.’
In the nearer future, the Pharmacopoeia’s new quarters will host a three-day international conference in June when 400 delegates will discuss the next steps toward harmonising the European, American and Japanese pharmacopoeias in order to establish worldwide drug quality standards.