EMA

EMA and US FDA seek potential candidate companies for joint GMP inspection programme

The European Medicines Agency (EMA) and the Food and Drug Administration of the United States of America (US FDA) continue to seek potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products. Companies that have submitted in parallel two equivalent marketing authorisation applications for the same medicinal product to both the EMA and the US FDA can request to participate in the pilot programme for joint pre-approval inspection should such an inspection be considered necessary by both agencies.

European Medicines Agency update on ongoing benefit-risk review of Avandia, Avandamet and Avaglim

The European Medicines Agency is currently reviewing rosiglitazone to determine the impact of new data from recent publications on the risk of cardiovascular problems on the benefit- risk profile of these medicines. Prescribers in the European Union are reminded to strictly follow the current restrictions in the product information. Avandia (rosiglitazone) was initially authorised in the European Union in July 2000 as second-line diabetes type-2 treatment to be used when other treatments have either failed or are unsuitable for a patient.

European Medicines Agency launches new website

The European Medicines Agency (EMA) unveiled its new corporate website, the site has been completely redesigned and rebuilt to optimize usability for the Agency's key online audiences and build on existing activities to improve openness and transparency. The Agency website now receives an average of half a million unique visits per month and is a key resource for patients, healthcare professionals, regulators and those interested in the regulation and safety of medicines in the European Union.

European Medicines Agency starts review of rosiglitazone-containing medicines

The European Medicines Agency has started a review of the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim, to determine whether new data on the risk of cardiovascular problems have an impact on their benefit-risk profile. The review by the Agency's Committee for Medicinal Products for Human Use (CHMP) follows the recent publication of further studies on the cardiovascular safety of rosiglitazone.

Call for expression of interest for health professional and patient organisations representatives

The European Commission is looking for three representatives from patient organisations and three representatives from healthcare professional organisations to join the Paediatric Committee (PDCO) as full members for a new three-year mandate. This call is intended to replace the members who were appointed for the period starting on 1 August 2008. Current members may reapply.

European Medicines Agency and European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP) launch 'ENCePP studies'

On 8 June 2010 the European Medicines Agency and the European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP) launched 'ENCePP studies'. Building on the foundations of the ENCePP network of Excellence, 'ENCePP studies' is a seal for EU-based, benefit/risk or risk studies that are carried out in compliance with the ENCePP code of conduct for independence and transparency and its methodological research standards and are entered into a publicly available electronic register before their start.

New certification procedure designed to help small and medium-sized enterprises developing innovative medicines

The European Medicines Agency's Committee for Advanced Therapies (CAT) adopted the first opinion on the certification of experimental data generated for an advanced therapies medicinal product (ATMP) under development by a small and medium-sized enterprise (SME).

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