EMEA and civil society

The European Medicines Agency (EMEA) held a workshop with the media on the 9 June 2008
Thomas Lonngren, Director of the chief European medicines regulator said that the information leaflets in medicines packaging is scaring patients out of taking their medicines. He said that a more positive messaging is needed to encourage patients to take their medicines.
"We should reconsider how we are writing the packaging leaflet so they (patients) can see the benefit (of the drug)." Mr Lonngren (...)

Representatives of European patients’ and consumers’ organisations have expressed their appreciation for the work being done by the European Medicines Agency (EMEA) to involve them in its core activity areas.
Over 92 % of people polled in a recent survey for EMEA say they are either satisfied or very satisfied with their overall interaction with the EMEA, with the remaining 7 % expressing neither satisfaction nor dissatisfaction.
Patient and consumer representatives expressed (...)

This article is updated with information relative to the ’clinical trials meeting’ organised by the EMEA on 3 October 2007.
Outcomes of the clinical trials meeting
The activities of the meeting on clinical trials organised by the EMEA on 3 October 2007 focused on strengths and shortcomings of the current legal framework. No general consensus was risen in this matter. In particular, the debate was characterised by diverging opinions on the directive’s quality.
A call for simplification and a (...)

During 2007, the EMEA Patient and Consumer Working Party (PCWP) will meet four times.
MEETING OF 16 FEBRUARY 2007
On 16 February 2007, the EMEA Patient and Consumer Working Party met for the first time this year.
The main item on the agenda was the election of the two co-chairs for the next 3 years and the setting up of working groups to tackle certain issues in more detail.
After a rigorous election procedure, Nikos Dedes from EATG was elected as co-chair from the patient and consumers’ (...)

The European Medicines Evaluation Agency issued a consultation in November 2006 to review the draft “Guideline on the readability of the label and package leaflet of medicinal products for human use”.
European Directive 2004/27/EC, which modified Directive 2001/83/EC, introduced important requirements to medicines’ packaging, in order to minimize medication errors and ensure the rational use of drugs.
The EMEA is now in the process of implementing the requirements set up in the (...)

2006 had four meetings of the EMEA/CHMP Working Group with Patients’ & Consumers’ Organisations in London, of which EPHA is an active member. Background documents can be found at the EMEA Working group with patient and consumer organisation’s website
The EMEA is still eager to receive new applications from organisations wishing to participate in its activities, specially those organisations representing patients of cardiovascular diseases and those working on paediatric medicines. (...)

This article has been updated with a summary of the EMEA/CHMP discussion in December 2005.
The European Medicine Evaluation Agency (EMEA) is a decentralised body of the European Union with headquarters in London.
EMEA’s main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.
The EMEA is divided in different Committees. The most relevant for human health is the Committee for Medicinal (...)

The European Medecines Agency (EMEA) has issued draft guidelines on the development of "similar biological medicinal products", the so-called biosimilar medecines.
The draft guideline follows two existing EMEA documents adopted in 2003 and aims at describing the EMEA approach to the development and approval of these products.
The final guidelines will define what is a biosimilar medicine and will be a "user guide" for applicants that claim biosimilarity of their products.
The aim of this (...)

The European Medicine Evaluation Agency (EMEA) is a decentralised body of the European Union with headquarters in London.
EMEA’s main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.
The EMEA is divided in different Committees. The most relevant for human health is the Committee for Medicinal Products for Human Use (CHMP). Giving the importance of this committee, EMEA decided to set (...)

The European Medicines Evaluation Agency (EMEA) has released recommendations for improving information for patients. The document was drafted together with stakeholders groups and covers three main areas:
information provision adapted to patients’ needs
developing appropriate communication tools
increasing public awareness on drugs and EMEA’s roles
EPHA has been involved in developing the recommendations on pharmacovigilance.
Patient information has been a key political issue and the (...)