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EMAUKEU

EMA prepares new system for detecting adverse drug reactions

06.03.2012 - The European Medicines Agency (EMA) calls it “the biggest change to the legal framework since the establishment of the Agency in 1995.” This year, the EU drug regulators are preparing new so-called pharmacovigilance measures to give every patient living in an EU member state the chance to report adverse drug reactions (ADRs) to their respective national regulatory authority.

An information campaign on direct reporting will be launched by the EMA and member states later this year. Preparations to implement the new pharmacovigilance rules (Regulation (EU) No 1235/2010 and Directive 2010/84/EU – adopted in December 2010) will begin in mid-July. The new rules will create many additional documentation tasks for drug developers and the Agency. 
Up to now, the EMA has focussed its post-marketing drug safety monitoring on the 568 centrally-authorised medicines for human use. But starting this year, the EU drug watchdog will step-by-step also include pharmacovigilance data from nationally authorised medicines. The London-based drug experts estimate the new responsibility will mean having to cope with at least 80,000 additional ADR reports per year. About 3,000 analyses will come in from the detection of new safety signals from EU-approved medicines, while a further 624 post-marketing safety studies per year will have to be assessed. 

“New rules governing the monitoring, identification and assessment of adverse events caused by pharmaceuticals will be launched in Europe in July 2012,” announced the EMA. A new committee named PRAC (Pharmacovigilance Risk Assessment Committee) will be responsible for the implementation of the new drug safety rules – and it has an ambitious working plan. First of all, PRAC will implement a procedure for protocol approval of safety studies on drugs that have already been approved at the EU level. Second, the committee will establish a process for the coordination of pharmaco­vigilance inspect­ions. Third, it will revise the process for the detection of adverse drug signals so that data inputs from nationally approved medicines can be included. 
Following meetings with the industry, the EMA is expected to publish details soon on the requirements for the electronic submission of a revised pharmaco­vigilance system master file. However, electronic submission of the safety data will have to be in place by 2015 at the latest. Until detailed guidance from PRAC is available, the EMA has published provisional information to help companies navigate through the new rules (“Information on transitional arrangements for pharmacovigilance legislation”). Additionally, the EMA published a draft concept paper defining Good Pharmacovigilance Practice (GVP).

http://www.european-biotechnology-news.com/news/news/2012-01/ema-prepares-new-system-for-detecting-adverse-drug-reactions.html

Industry reportGermany

27.04.2016 More revenue, more jobs, more financing, more R&D expenditure – all signs point towards sustainable growth in the German biotech sector. These are the results of the most recent company survey 2016, published by biotechnologie.de. The report was once again conducted alongside the biotech standards defined by the organisation for economic cooperation and development (OECD).

Clinical ResearchFrancePortugal

21.04.2016 An expert panel’s final report on the fatal drug trial earlier this year in France states that the death of one of the participants was most likely caused by the drug’s toxicity and not by any violation of the rules.

Immuno-oncologyNetherlandsBelgium

21.04.2016 For up to US$685m (€606m), Dutch ArgenX has outlicensed its human antibody programme ARGX-115 to AbbVie. The pre-clinical immuno-oncology candidate targets a protein believed to contribute to immunosuppressive effects of T-cells.

RegulatorySwitzerlandEU

20.04.2016 The US government is forking out up to US$100m to get Basilea Pharmaceutica’s broad-spectrum antibiotic ceftobiprole on the US market. In the EU, ceftobiprole is already available.

Immuno-oncologyUK

19.04.2016 British drug developer Heptares Therapeutics and mAb maker Kymab Ltd have partnered up in yet another immuno-oncology collaboration. The companies plan to discover antibody meds targeting a superfamily of receptors.

FinancingSwitzerlandFranceEUGermanyDenmark

15.04.2016 Not every company is put off by the current stock market climate. Swiss biopharma company GeNeuro has gone public at Euronext Paris, raising €33m in the process. Others, meanwhile, have to find different ways to raise money.

Event ReviewSwitzerlandBelgiumEU

13.04.2016 Despite political disturbances, 2015 was a good year for the biotech scene in Switzerland. Net sales increased by 5.1% to CHF5,133m and 400 additional people found jobs in the sector. As usual, the new numbers were presented at the annual Swiss Biotech Day – which set new records as well.

FinancingGermanyNetherlandsEU

12.04.2016 German-Dutch life science investment specialist Forbion Capital Partners has raised more than €180m for its venture capital fund Forbion Capital Fund III. Once more the money will primarily go to European start-ups.

Event ReviewGermanyEU

08.04.2016 Do you win by being innovative?, was the question asked at this year’s DIA Euromeeting in Hamburg. In a relaxed and cooperative atmosphere, regulators, physicians and patients had ample opportunity to interact with the healthcare industry.

M&AIrelandEU

07.04.2016 Pfizer and Allergan have called off their merger, cancelling plans to relocate the US pharma giant to Ireland to avoid US taxation. The US government has put a spoke in Pfizer’s wheels - an unfair move, Allergan says.

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