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).



26.11.2015 Bioeconomy movers and shakers from every corner of the globe met this week at the world’s first Global Bioeconomy Summit in Berlin to discuss, debate and define better ways to ensure the bioeconomy succeeds on an international level.


24.11.2015 After weeks of speculation it is official: US pharma major Pfizer and Irish Botox maker Allergan will merge. With the deal, Pfizer is planning to dodge the high US taxes, causing indignation among US politicians.


23.11.2015 Amidst talk of the IPO window closing and cancelled flotations, diagnostics firms are still striking a chord with investors. Swedish Immunovia and German Curetis are successfully raising public money.


20.11.2015 French Sanofi and British AstraZeneca are giving open innovation a go: The two pharma giants will exchange thousands of compounds – for free.


19.11.2015 French gene editing company Cellectis has granted Servier the rights to bring cancer immunotherapy UCART19 to market. Servier in turn has teamed up with Pfizer to hurry development along.


17.11.2015 The first Italian accelerator specifically for biotech projects has been launched with help from Sofinnova Partners. The plan of BiovelocITA: to help Italy grow into one of Europe’s strongest biotech markets.


13.11.2015 Scientists in Bath, UK, have developed a medical dressing that turns fluorescent green when it detects infection. The researchers hope that the smart burns dressing will help fight antibiotic resistance.


13.11.2015 Out with the old: Roche is discarding four sites with 1,200 staff in an effort to restructure its manufacturing network for small molecules. Instead, a new manufacturing site will be built in Switzerland.


10.11.2015 Algae have many skills, but cancer fighting was not one of them – until now. Researchers from Australia and Germany have genetically engineered diatom algae to accurately deliver chemotherapeutic drugs.


10.11.2015 AstraZeneca has plucked Californian biopharma company ZS Pharma from under Actelion’s nose. The UK company is paying US$2.7bn (€2.5bn) to acquire ZS and its promising hyperkalaemia treatment currently under US regulatory review.


All Events


Strasbourg (F)

BioFIT 2015

Current issue

All issues

Product of the week


Stock list

All quotes


  • EPIGENOMICS (D)2.26 EUR20.86%
  • SAREUM HOLDINGS (UK)0.21 GBP10.53%


  • THERAMETRICS (CH)0.04 CHF-20.00%
  • CO.DON (D)2.35 EUR-7.84%
  • DIAMYD MEDICAL -B- (S)9.40 SEK-6.00%


  • PLETHORA (UK)5.50 GBP76.3%
  • CELLECTIS (F)30.25 EUR34.9%
  • PROTHENA PLC (IE)73.19 USD34.8%


  • EPIGENOMICS (D)2.26 EUR-48.5%
  • EVOCUTIS (UK)0.09 GBP-40.0%


  • KARO BIO (S)37.80 SEK5300.0%
  • CHRONTECH PHARMA (S)0.34 SEK1600.0%
  • GALAPAGOS (B)46.32 EUR258.0%


  • BIOTEST (D)15.77 EUR-80.4%
  • EVOCUTIS (UK)0.09 GBP-78.6%

No liability assumed, Date: 27.11.2015