EMA

Paper calls for continued support for development of advanced therapies

The European Medicines Agency needs to continue reaching out to academic institutions, charities and small companies developing advanced-therapy medicines, according to a paper published in the journal Molecular Therapies earlier this month. The paper, written by members of the Committee for Advanced Therapies (CAT), its secretariat and other European Medicines Agency staff, found that the main sponsors of clinical trials of advanced-therapy medicines performed in the European Union (EU) between 2004 and 2010 often have limited financial resources and a limited capacity to navigate regulatory procedures.

European Medicines Agency launches electronic application form pilot

The European Medicines Agency has launched a pilot of electronic application forms for submissions of centralised marketing authorisation applications. The pilot, which runs for four months until mid-July 2012, allows pharmaceutical companies to apply for initial marketing authorisation applications for human medicines, and variation and renewal applications for human and veterinary medicines, using an interactive PDF form.

European Medicines Agency focuses on new legislation in 2012 work programme

This year, the European Medicines Agency's activities will concentrate on the implementation of the pharmacovigilance legislation and preparations for the new legislation on falsified medicines, according to the work programme 2012, published last week. The document, adopted by the Agency's Management Board at its meeting on 15 December 2011, forecasts a stable number of applications for marketing authorisation for human and veterinary medicines in 2012.

European Medicines Agency and European Commission extend confidentiality arrangement with Japan

The European Medicines Agency and the European Commission have extended their confidentiality arrangement with the Japanese medicines regulatory authorities for a year. The extended arrangements allows the Agency to continue to exchange information on the regulation of human medicines with Japan's Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) until February 2013.

European Medicines Agency publishes guideline on use of pharmacogenetics in evaluating pharmacokinetics of medicines

The European Medicines Agency has published a guideline advising pharmaceutical companies how to integrate studying the role of genetic variability between patients during the development of medicines. The guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products clarifies the requirements for the analysis of the effect of genetic variability on the way the human body handles medicines.

European Medicines Agency counts down to introduction of new pharmacovigilance legislation

The European Medicines Agency, together with the European Member States and the European Commission, is preparing for the introduction of the new pharmacovigilance legislation in July this year, which will bring the biggest change to the legal framework since the establishment of the Agency in 1995. Over the next five months, the Agency will finalise its preparations for the inaugural meeting of the new Pharmacovigilance Risk Assessment Committee (PRAC), planned for 19 July 2012.

European Medicines Agency and European Food Safety Authority commit to greater co-operation

The European Medicines Agency (EMA) and the European Food Safety Authority (EFSA) have today signed a memorandum of understanding setting out their commitment to fostering co-operation on areas of common interest. The new agreement builds on the existing collaboration between the agencies, setting out a number of activities to ensure that they make best use of their resources while avoiding duplication of effort.

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