The requirement for the target animal batch safety test (TABST) for veterinary vaccines has been formally withdrawn from the European Pharmacopoeia, effective as of April 2013.
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The European Medicines Agency (EMA) is holding a one-day workshop on parallel scientific advice with health-technology-assessment (HTA) bodies on evidence-generation in human-medicine development. The workshop is a joint undertaking of the EMA, HTA bodies and developers. Registration open until 30/08/2013. Places limited.
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The European Medicines Agency (EMA) is inviting expressions of interest in attending its workshop on parallel scientific advice in drug development with health-technology-assessment (HTA) bodies on 26 November 2013.
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The Committee adopted by consensus a positive opinion for an extension of the existing authorisation for Econor (valnemulin) from Novartis Animal Health GmbH concerning the addition of a new target species, rabbits for reduction of mortality during an outbreak of epizootic rabbit enteropathy.
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The Pharmacovigilance Risk Assessment Committee (PRAC) made recommendations on four safety referrals at its June 2013 meeting.
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The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded following a review of the available evidence that the benefits of infusion solutions containing hydroxyethyl-starch (HES) no longer outweigh their risks and therefore recommended that the marketing authorisations for these medicines be suspended.
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The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended a series of measures to address safety concerns with codeine-containing medicines when used for the management of pain in children.
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The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of flupirtine-containing medicines and recommended restrictions in their use.
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The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the effects of the painkiller diclofenac on the heart and circulation when given systemically (by means such as capsules, tablets or injections) are similar to those of selective COX-2 inhibitors, another group of painkillers.
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The principal aim of this guideline is to adapt some specific aspects of the quality guidance already in place for other recombinant production systems to the special case of transgenic animal systems.
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The European Medicines Agency has released a revision of the guideline addressing the clinical and non-clinical issues related to similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance for a six-month public consultation.
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This guideline lays down the non-clinical and clinical requirements for a biological medicinal product claiming to be similar to another one already marketed (“biosimilar”).
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The European Medicines Agency has published a public statement on authorisation of bluetongue vaccines, which proposes changes to the implementing rules of the fee regulation related to inactivated vaccines against bluetongue disease.
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The aim of this position paper is to raise awareness for this issue, provide insight with regards to how the benefit-risk assessment of such products might be impacted and to discuss in general terms how the risk of medication errors could be adequately addressed.
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The European Medicines Agency has released the sixth revision of the guideline on the acceptability of names for human medicinal products processed through the centralised procedure for public consultation.
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The current update of this guideline provides further recommendations on the requirements for acceptability and submission of proposed (invented) names of medicinal products processed through the centralised procedure. Specific aspects of the criteria applied to address safety and public health concerns, international non-proprietary names issues, product-specific concerns and the procedure for submission of proposed (invented) names requests are further clarified.
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This Module addresses the legal requirements detailed in Title IX of Directive 2001/83/EC [DIR] and Chapter 3 of Regulation (EC) No 726/2004 [REG], which are applicable to competent authorities in Member States, marketing authorisation holders and the Agency as regards the collection, data management and reporting of suspected adverse reactions (serious and non-serious) associated with medicinal products for human use authorised in the European Union (EU).
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Risk minimisation measures are public health interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient should adverse reactions occur. Planning and implementing risk minimisation measures and assessing their effectiveness are key elements of risk management.
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The European Medicines Agency has released a revision of the guideline on good pharmacovigilance practices (GVP) module VI on the management and reporting of adverse reactions to medicinal products for a two-month public consultation.
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The European Medicines Agency (EMA) and EUnetHTA, the European Network for Health Technology Assessment, met to review the progress of their cooperation in London on 14 May 2013.
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This provisional priority list of off-patent medicines is intended to be the basis for potential future funding within the Horizon 2020 Programme of the European Commission. As preparations for Horizon 2020 still are under way, no further information can be provided concerning the availability, timing and organisational aspects of any possible future calls involving off-patent paediatric medicinal products.
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Marketing-authorisation holders of human medicines will now have to declare the reasons that lead them to take any of the actions below to the European Medicines Agency (EMA), in accordance with the amendments to the 2010 pharmacovigilance legislation of the European Union (EU):
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This meeting is part of regular stakeholder liaison. Subjects discussed include the threat to innovation in the area of antimicrobials, an update on current issues in the area of residues to veterinary medicines in foodstuff of anima origin, measures taken to promove the 3 Rs (replacement, reduction and refinement) and the availability of products for bees.
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This meeting is part of regular stakeholder liaison. Subjects discussed included the threat to innovation in the area of antimicrobials; update on current issues in the area of residues to veterinary medicines in foodstuff of anima origin; measures taken to promove the 3 Rs (replacement, reduction and refinement) and the availability of products for bees.
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This guideline replaces Note for Guidance on the use of bovine serum in the manufacture of human biological medicinal products (CPMP/BWP/1793/02).
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The European Commission has published a revised version of the application form for all marketing-authorisation applications for medicines for human use.
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