News
GMP: GVP Update
29.09.2016
On 8 August 2016, draft revision 2 of Module VI on management and reporting of adverse reactions and draft revision 1 (major revision) of Module IX on signal management with its Addendum I
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EMA: Draft guideline on good pharmacovigilance practices (GVP) - Module VI – Management and reporting of adverse reactions to medicinal products (Rev. 2)
10.08.2016
This Module of GVP addresses the legal requirements detailed in Title IX of Directive 2001/83/EC 183 and Chapter 3 of Title II of Regulation (EC) No 726/2004, which are applicable to competent
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EMA: Draft guideline on good pharmacovigilance practices (GVP) - Module IX – Signal management (Rev. 1)
10.08.2016
Regulation (EC) No 726/2004, Directive 2001/83/EC and Commission Implementing Regulation (EU) No 520/2012 (hereinafter referred to as REG, DIR and IR, respectively) include provisions for signal
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EMA: Draft guideline on good pharmacovigilance practices (GVP) - Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions
10.08.2016
Monitoring of databases of spontaneously reported suspected adverse reactions (in the format of individual case safety reports (ICSRs), see GVP Module VI) is an established method of signal
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EMA: Regulatory information - adjusted fees for applications to European Medicines Agency from 1 April 2016
14.03.2016
The European Medicines Agency reminds applicants and marketing-authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on
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EC: Pharmacovigilance - Major developments
14.03.2016
As of 1 February 2016 marketing authorisation holders will no longer be required to submit type IA variations in relation to administrative changes to the Qualified Person Responsible for
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EMA: Draft guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market
17.02.2016
In order to stimulate the development of new veterinary medicines intended for minor uses or minor species (MUMS)/limited market the CVMP developed guidelines on data requirements for MUMS/limited
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RAPS: EU Regulation Requires New Safety Features on Drug Packaging by 2019
17.02.2016
A new regulation will require prescription drugmakers in all but three EU countries to incorporate new safety features on their product packaging by 9 February 2019. ...
RAPS: Zika: FDA Recommends Deferring At-Risk Blood Donors for Four Weeks
17.02.2016
The US Food and Drug Administration (FDA) is recommending blood banks defer donations from recent travelers to Zika-affected countries. The recommendation comes in the form of a new guidance
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URPL: Information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of February 16, 2015 on the support which European experts will provide in the context of the global response to the growing epidemi
17.02.2016
This document is announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of February 16, 2015 on the support which European experts
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