Aktualności
EMA: EMA promotes consistent development of bioequivalence studies through product-specific guidance
21.11.2013
The European Medicines Agency has released its first product-specific guidance on the demonstration of bioequivalence for 16 active substances. ...
EMA: Second draft public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs)
21.11.2013
It became apparent during assessment of Symphytum officinale (monograph EMEA/HMPC/572844/2009) that the risk assessment of pyrrolizidine alkaloids (PAs) poses considerable difficulties, with
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Polish Ministry of Health: Project of regulation of Minister of Health concerning a way and mode of pharmacovigilance of veterinary medicinal products.
21.11.2013
This document is a project of regulation of Minister of Health concerning a way and mode of pharmacovigilance of veterinary medicinal products. ...
EMA: Second draft guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation
21.11.2013
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, occurring in 1–2% of the general population. AF confers a 5-fold risk of stroke, and one in five of all strokes is
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EMA: New EMA guidance on development of antibacterials to help in the fight against multidrug-resistant pathogens
14.11.2013
The European Medicines Agency (EMA) released an Addendum to the guideline on the evaluation of medicinal products indicated for the treatment of bacterial infections. One of the most important
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Polish Ministry of Health: Regulation of Polish Minister of Health of November 5, 2003 amending regulation on requirements concerning labelling packages of medicinal products and contents of the leaflet.
14.11.2013
This Regulation of Polish Minister of Health amends regulation on requirements concerning labelling packages of medicinal products and contents of the leaflet. ...
FDA: Draft guidance - Pulmonary Tuberculosis: Developing Drugs for Treatment
14.11.2013
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of pulmonary tuberculosis. Specifically, this guidance addresses the FDA’s current
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EMA: Amendments to the pharmacovigilance legislation: new notification requirements for marketing-authorisation holders and changes to scope of European safety referrals
07.11.2013
Amendments of the European Union (EU) pharmacovigilance legislation that were adopted in October 2012 came into force on Monday 28 October 2013. These changes, which cover various aspects of the
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EMA: European Medicines Agency and US Food and Drug Administration release further guidance on quality-by-design approach
07.11.2013
The European Medicines Agency (EMA) and the United States Food and Drug AdministrationExternal (US FDA) have published a second joint question-and-answer document that provides guidance on the
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Polish Ministry of Health: Act of Sep 27, 2013 of an act amendment – Pharmaceutical Law and other acts
07.11.2013
The document concerns an amendment of pharmaceutical law. A crucial element of accepted amendments is remodelling the definition of the concept of \"adverse reaction to medicinal product\" and
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