The European Directorate for the Quality of Medicines (EDQM), the organisation responsible for the European Pharmacopoeia, was praised by speakers from the European Commission and the European Medicines Agency (EMA) during the plenary session, with speeches focusing on its role as a reference for the drug industry.
Andrezej Rys from DG Health and Consumers told attendees that although the regulatory environment in which the EDQM orperates has changed since the organisation was set up, its underlying role and that of the wider EU healthcare system has not.
"After the thalidomide scandal in 1965 a directive was enacted requiring that every memeber state check the quality, efficacy and safety of medical products sold in Europe," Rys said, adding that "while the rules [covering medicines] have grown over the years, the basic principles remain unchanged."
"The European regulatory framework has suceeded in providing a high level of protection for patients and the work of your organisation [the EDQM] has been very valuable in this regard. The links between the EDQM and the European Union go back a long way" Rys said, citing the European pharmacopoeia, Certificates of Suitability (CEPs) as key to the relationship.
Fight fakes
Rys also said the EDQM has a major role to play in preventing the sale of counterfeits.
"The commisison is working on the final implementation of the FMD and speaking about safety features that will allow the identification of individual parts of medicines... it is paramount that information on cases of falsification taking place in the legal supply chain reach the commission swiftly in order for us to adopt legislation accordingly.
"We continue to count on the OMCL and EDQM in this regard," he went on to say, adding that establishment of "OMCL working group on falsified medicines is testament to how EDQM is rising to face new challenges."
Collaboration
Anabela de Lima Marcal, head of complicance and inspections at the EMA, also praised the EDQM, particularly for its willingness to collaborate.
"In terms of EMA and EDQM coopertion, there are three main areas in which we collaborate closely: sampling and testing of products; assessments relating to the quality of medicines; and GMP-related issued.
"In terms of the sampling and tesing programme...is to verify the compliance of centrally authourised products with quality specifications. This programme has been running with the EDQM since 1998...and we have approximately 550 centrally authorsed products that have been tested" she said.
The EDQM also advises the EMA on its other developmemt programmes according to Marcal, who said the organisation had provided siginficant input into its risk-based product testing work.
Going forward Marcal said future collaborations between the EMA and EDQM are likely to involve more small molecule generic drugs, biological medicines and harmonization of procedures.