Politics

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

CommercialisationEU

10.02.2016 In future, meds will come in packages sporting a unique barcode and an anti-tampering device. These measures are part of the EU’s new regulation to safeguard against falsified medicines.

Clinical ResearchFrancePortugalEU

05.02.2016 It is not yet clear why a man died during a first-in-man clinical trial in January. A preliminary report found several “major shortcomings” by responsible CRO Biotrial. However, all regulations were complied with.

M&ASwitzerland

04.02.2016 After having dodged multiple takeover attempts by Monsanto last year, agrobusiness giant Syngenta has now agreed to be acquired by chemical corporation ChemChina. The Swiss company also announced plans to go public within a few years.

FinancingEUUKBelgium

01.02.2016 Newly formed Medicxi Ventures, a life sciences-dedicated VC firm based in London, Geneva and Jersey, has closed a €210m investment fund to reinvest in European early-stage assets.

ResearchUKEU

01.02.2016 Altering human DNA with the efficient gene editing method CRISPR/Cas9, especially germline modifications, was long considered a taboo. Now, however, UK scientists have received official approval to tinker with embryo DNA.

M&ASwedenIceland

28.01.2016 Swedish infectious disease specialist Enzymatica has bagged Icelandic company Zymetech, who produces the patent-protected enzyme used in Enzymatica’s own common cold blocker ColdZyme.

R&DUK

27.01.2016 Three UK universities have teamed up with three pharma companies to create the Apollo Therapeutics Fund. With the tech transfer fund, the consortium aims to develop scientific research into medicines.

Clinical TrialsGermany

25.01.2016 Affimed means to put a promising drug combination to the test. With support from MSD, the German biopharma will carry out clinical trials for an immunotherapy combining treatments of both companies.

AMREU

21.01.2016 Stop squandering antibiotics and make research profitable again: at the World Economic Forum in Swiss Davos, 83 pharmaceutical companies have called for a unified approach towards the threat of antimicrobial resistance.

M&AFinland

19.01.2016 Biotie Therapies has long been expanding its business in the US. Now, the Finnish company is set to be taken over by US company Acorda Therapeutics, which is paying €321m for the shares.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • SAREUM HOLDINGS (UK)0.28 GBP12.00%
  • IXICO (UK)35.50 GBP4.41%
  • SUMMIT (UK)4.03 GBP3.87%

FLOP

  • SWEDISH ORPHAN BIOVITRUM (S)12.45 USD-23.38%
  • BIOTIE THERAPEUTICS (FI)0.14 EUR-22.22%
  • THERAMETRICS (CH)0.04 CHF-20.00%

TOP

  • VERONA PHARMA (UK)3.25 GBP22.6%
  • IXICO (UK)35.50 GBP20.3%
  • SAREUM HOLDINGS (UK)0.28 GBP16.7%

FLOP

  • BIONOR PHARMA (N)0.80 NOK-48.7%
  • PROTHENA PLC (IE)30.94 USD-42.6%
  • PLETHORA (UK)2.62 GBP-36.4%

TOP

  • CHRONTECH PHARMA (S)0.34 SEK3300.0%
  • KARO BIO (S)24.00 SEK2826.8%
  • 4SC (D)3.04 EUR257.6%

FLOP

  • BIOTEST (D)11.91 EUR-87.3%
  • NEUROVIVE PHARMACEUTICAL AB (S)8.70 SEK-85.3%
  • EVOCUTIS (UK)0.08 GBP-71.4%

No liability assumed, Date: 09.02.2016