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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 ...

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, ...

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 ...

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The Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a survey to gather input on its new draft guidance on the re-manufacturing of single-use devices.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 ...

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 ...

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 ...

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 ...

REUTERS: Another Indian firm under fire for shoddy clinical trials work

16.07.2015
Another Indian clinical research organisation, Quest Life Sciences of Chennai, is in trouble over defective trials work, including manipulation of heart readings, according to a warning issued by ...

RAPS: FDA Finalizes Six-Month Drug Shortage Notice Regulation

16.07.2015
In 2011, after several years of worsening drug shortages, the Obama Administration issued Executive Order 13588 – Regarding Prescription Drug Shortages calling for measures to improve the ...