Re-shaping a regulatory agency fit for the future

07-05-2013

The first details of the planned reorganisation of the European Medicines Agency (EMA) have been announced. Rooted firmly in the Agency’s overall public and animal health mission, the changes reflect a renewed focus on three key elements: how to better support the scientific work of the EMA ...

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06-05-2013

The European Medicines Agency (EMA) has been ordered by the General Court of the European Union not to provide documents as part of two access-to-documents requests until a final ruling is given by the Court. These interim rulings were made as part of court cases brought by two pharmaceutical ...

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30-04-2013

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 ...

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EMA to give advice to European Commission on public and animal health impact

17-04-2013

The European Medicines Agency (EMA) will provide advice on the impact on public health and animal health of the use of antibiotics in animals. The request was made by the European Commission as part of its ‘Action Plan against the rising threats from Antimicrobial Resistance ...

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21-12-2012

Gyros AB announced its quality management system has received ISO 9001:2008 certification. The Gyros platform is used by biopharmaceutical companies and their service providersto improve productivity and efficiency during the development of biotherapeutics and vaccines, boosting time-critical ...

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17-09-2012

Gerresheimer Medical Plastic Systems Dongguan Co. is an FDA-inspected medical device manufacturer for the production of a new inhaler. As part of the product’s drug approval on the American market, the entire value creation chain was carefully examined in accordance with the strictest ...

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18-07-2012

CellGenix’ quality management system was certified in April 2012 on the requirements of DIN EN ISO 9001:2008 standard by the TÜV Rheinland Cert GmbH. To highlight CellGenix’ commitment to quality and service the certification of ISO 9001:2008 covers all relevant functions of the company, ...

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Better protection of public health through strengthened EU system for medicines safety

04-07-2012

The European Medicines Agency welcomes the start of new European Union (EU) legislation on pharmacovigilance. This new piece of legislation aims to promote and protect public health by strengthening the existing Europe-wide system for monitoring the safety and benefit-risk balance of ...

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27-06-2012

The Merck Animal Health (known as MSD Animal Health outside the United States and Canada) foot-and-mouth disease (FMD) research and vaccine manufacturing site in Cologne (Germany) is among the first facilities worldwide that have been certified according to the new standard CWA 15793:2008 on ...

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19-06-2012

Dalton Pharma Services announced that the company has received GLP certification from The Standards Council of Canada.SCC accreditation is recognized around the globe. In Canada, SCC administers the OECD GLP initiative. OECD (Organization for Economic Development and Co-operation) has 34 ...

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