Aktualności
EMA: Stimulating the development of medicines for children
23.07.2015
EMA’s revision of class waiver list expected to push the exploration of many more medicines for use in children
The European Medicines Agency’s Paediatric Committee (PDCO) has revised the
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EMA: Draft guideline on manufacture of the finished dosage form
23.07.2015
This guideline replaces the note for guidance on the manufacture of the finished dosage form (CPMP/QWP/486/95). The note for guidance has been updated to reflect changes to the format and content
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EMA: Draft asenapine sublingual tablets 5 and 10 mg product-specific bioequivalence guidance
23.07.2015
The European Medicines Agency has decided to routinely publish product-specific bioequivalence guidance for a more consistent approach to the assessment of marketing authorisation applications for
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MHRA: Fit for purpose MHRA can lead the way for global regulatory reforms
23.07.2015
The government agency that regulates medicines and medical devices to ensure their quality, safety and efficacy can place the UK at the forefront of a global drive to improve public health,
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GMP: Counterfeit Medicines - A current Case shows that also medium-sized Companies are affected
23.07.2015
The issue of counterfeit medicines is often played down as it only affects the expensive blockbuster products anyway - mostly just products of the large pharmaceutical manufacturers. However, this
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RAPS: MHRA Wants Input on Single-Use Device Re-Manufacture Guidance
23.07.2015
The Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a survey to gather input on its new draft guidance on the re-manufacturing of single-use devices. ...
URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of July 21, 2015 concerning the publication of the Regulation of the Minister of Health of 8 July 2015 on the method of determinatio
23.07.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of July 21, 2015 concerning the publication of the Regulation
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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of July 23, 2015 concerning the obtainment permission to grouping modifications to the applications referred to in Art. 31 paragraph
23.07.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of July 23, 2015 concerning the obtainment permission to
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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of July 16, 2015 concerning the investigation by the European Medicines Agency safety profile of vaccines against human papilloma vi
16.07.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of July 16, 2015 concerning the investigation by the European
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FDA: FDA approves new drug to treat heart failure
16.07.2015
The U.S. Food and Drug Administration today approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death
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