EMA

Croatia becomes a new member of the European medicines network

On 1 July 2013 Croatia joined the European Union. Croatia is now part of the European medicines network and its representatives will be fully involved in the activities of the seven Scientific Committees of the European Medicines Agency (EMA) as well as the Agency's other activities. Preparation for the participation of Croatia in the EMA's activities began in 2007, when the European Commission's Instrument for Pre-accession Assistance (IPA) programme for Croatia was put in place. Under the framework of the IPA, the Agency worked with the Croatian national competent authorities to prepare their participation in the EMA's activities and contribute to the creation of information-exchange systems to support its integration into the European medicines network.

Public consultation open on guideline on the acceptability of names for human medicines

The European Medicines Agency has released the sixth revision of the guideline on the acceptability of names for human medicinal products processed through the centralised procedure for public consultation. The current update of this guideline provides further recommendations on the requirements for acceptability and submission of proposed (invented) names.

European Medicines Agency issues six key recommendations to tackle the issue of medication errors

The European Medicines Agency (EMA) has issued six key recommendations to tackle the issue of medication errors causing harm in the European Union (EU). These recommendations are described in the medication-errors workshop report. This workshop was held by the Agency from 28 February to 1 March 2013 to raise awareness of this important public-health issue. The Agency, in collaboration with the European Commission and the EU regulatory network, will now develop an action plan, which it will publish before the end of the year.

European Medicines Agency simplifies processing of fee reductions for orphan medicines

The European Medicines Agency has cancelled the procedure by which sponsors of medicines with an orphan designation need to inform the Agency of their intention to submit an application in order to be eligible for a fee reduction. This forms part of the Agency's effort to reduce administrative burden for applicants and streamline the procedures for fee reductions. Medicines that have been granted orphan designation by the European Commission on the recommendation of the Agency's Committee for Orphan Medicinal Products (COMP) are eligible for fee reductions for a range of regulatory activities.

Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh

Following the recent recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has endorsed by majority the PRAC recommendation to suspend the marketing authorisations of tetrazepam-containing medicines across the European Union (EU). The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national marketing authorisation procedures across the EU.

Stem cell therapy treatments

Concerns have been raised in the media about certain stem cell therapy treatments. These sorts of new techniques potentially offer exciting possibilities to patients for the treatment of a range of difficult or previously untreatable conditions. Like all treatments, these techniques also come with benefits and risks. Specific rules were introduced in the European Union (EU) in 2007 to ensure that medicines involving cell therapy are subject to appropriate authorisation, supervision and controls in order to reduce and manage those risks.

European Medicines Agency publishes report on patient recruitment and geographical location of clinical trials

Almost 62% of the patients in pivotal trials submitted in marketing-authorisation applications (MAAs) to the European Medicines Agency between January 2005 and December 2011 were recruited outside of the European Economic Area (EEA) and Switzerland, according to an analysis performed by the Agency. The report on clinical trials submitted in MAAs to the European Medicines Agency provides an overview of the distribution of the numbers of patients, investigator sites and pivotal clinical trials included in MAAs submitted to the Agency, as well as the number and location of sites that were inspected.

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