News
EMA: Gardasil 9 offers wider protection against cancers caused by human papillomavirus (HPV)
16.04.2015
Vaccine covers five more types of HPV than previously approved Gardasil vaccine
The European Medicines Agency (EMA) has recommended Gardasil 9 (human papillomavirus vaccine) for the prevention
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EMA: Substances considered as not falling within the scope of Regulation (EC) No. 470/20091, with regard to residues of veterinary medicinal products in foodstuffs of animal origin
16.04.2015
Regulation (EC) No. 470/2009 of 6 May 2009 lays down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin. The
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EMA: Compilation of individual product-specific guidance on demonstration of bioequivalence
16.04.2015
The general European Union requirements for bioequivalence demonstration are laid out in the Guideline on Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1). In addition, the CHMP
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MHRA: Medicines regulator launches call for evidence on previously licensed oral hormonal pregnancy tests
16.04.2015
The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched a public call for evidence relating to the use of oral hormonal pregnancy tests (HPTs, which are no longer
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GMP: Revision of relevant PIC/S Guidance Documents in 2014
16.04.2015
Amongst the guidance documents of the European Union and of the US authorities, the PIC/S (Pharmaceutical Inspection Co-operation Scheme) published the revisions of two relevant guidance
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GMP: Mixing, Diluting, or Repackaging Biological Products - FDA Draft Guidance
16.04.2015
In February, the FDA published a new draft guidance on \"Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application\". Background is the
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GMP: New EU GMP Annex 15 Revision published - Valid as of 1 October 2015
16.04.2015
In February 2014 the draft for the revision of EU GMP Annex 15 was published (see the GMP-News from 11 February 2014 \"Revision of the EU GMP Annex 15 for Qualification and Validation
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RAPS: Pharmaceutical Trade Groups Propose Overhaul of Drug Safety Update System
16.04.2015
In a rare show of unity, two trade groups respectively representing the branded and generic pharmaceutical industries have proposed an alternate policy meant to replace the US Food and Drug
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RAPS: EU Committee Confirms Increased Risk with Ibuprofen at High Doses
16.04.2015
A European committee has confirmed that high doses of ibuprofen, a popular over-the-counter (OTC) anti-inflammatory drug, can increase a patient\'s risk for cardiovascular issues. ...
URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 2, 2015 concerning a temporary interruption in the supply of medicinal products: Insuman Rapid, Basal and Comb (human insul
16.04.2015
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of April 2, 2015 concerning a temporary interruption in the
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