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EMA / PRAC: one year of public health promotion and protection

“In a busy, exciting and productive first year establishing the new Pharmacovigilance Risk Assessment Committee (PRAC), the Committee has proactively grasped the opportunities of the new pharmacovigilance legislation to strengthen European drug safety. By involving patients and healthcare professionals in our decision-making, strengthening the science base of risk assessment, and working transparently, we have made great strides towards a [...]

2016-12-11T18:40:35+00:0022.07.2013|Pharmacovigilance, Regulatory Affairs|

FDA halts clinical trial of drug Revlimid (lenalidomide) for chronic lymphocytic leukemia due to safety concerns

The U.S. Food and Drug Administration (FDA) halted a clinical trial of the anti-cancer drug Revlimid (lenalidomide) because of significant safety concerns.  The ORIGIN trial (NCT00910910), which was evaluating Revlimid treatment for a new use as an initial therapy for chronic lymphocytic leukemia (CLL) in patients 65 years and older, showed higher rates of death [...]

2016-12-11T18:40:35+00:0019.07.2013|Pharmacovigilance, Regulatory Affairs|

EMA welcomes new Head of Legal Service

The European Medicines Agency (EMA) welcomes Stefano Marino as new Head of Legal Service. An Italian national, Mr Marino holds a law degree from the University of Florence, where he graduated in international law. He is an expert in pharmaceutical and corporate law with a long career as legal counsel and member of senior management committees, [...]

2013-08-01T18:11:42+00:0019.07.2013|Regulatory Affairs|

UK MHRA GLP quality assurance statements guidance document has been revised

The MHRA GLP guidance document on the content of GLP quality assurance statements has been revised. During routine GLP compliance monitoring inspections, GLP inspectors will review completed regulatory studies. During the review of these studies, inspectors occasionally encounter issues relating to the information contained within the quality assurance Statement. The purpose of this note is to [...]

2013-08-01T18:10:22+00:0018.07.2013|Regulatory Affairs|

FDA permits marketing of first brain wave test to help assess children and teens for ADHD

The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. When used as part of a complete medical and psychological examination, the device can help confirm an ADHD diagnosis or a clinician’s decision [...]

2013-08-01T18:08:45+00:0016.07.2013|Regulatory Affairs, Resources|

EMA: Meeting highlights from the PRAC of 8-11 July 2013

The PRAC – one year of public health protection and promotionThe Pharmacovigilance Risk Assessment Committee (PRAC) has marked the successful completion of its first year of operation. The PRAC was established under the pharmacovigilance legislation that came into force in June 2012 to improve public health promotion and protection by strengthening the EU’s pharmacovigilance system. The Committee held its first meeting in July 2012. PRAC welcomes Croatian [...]


FDA approves new treatment for a type of late-stage lung cancer

The U.S. Food and Drug Administration today approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.  Lung cancer is the leading cause of cancer-related death among men and women. According to the [...]

2016-12-11T18:40:35+00:0012.07.2013|Drug Development Strategy|

UK MHRA Drug Safety Update: July 2013 (Volume 6, Issue 12)

The monthly newsletter (Volume 6, Issue 12 (July 2013) from the Medicines and Healthcare products Regulatory Agency and its independent advisor the Commission on Human Medicines Drug safety advice Codeine for analgesia: restricted use in children because of reports of morphine toxicity Codeine should only be used to relieve acute moderate pain in children older than 12 [...]

2016-12-11T18:40:35+00:0012.07.2013|Pharmacovigilance, Regulatory Affairs|

Ventes de médicaments en France : le rapport d’analyse de l’année 2012

L’édition 2012 du rapport d’analyse des ventes de médicaments en France met en évidence une contraction du marché pharmaceutique en valeur (- 1,5%) suivant un ralentissement progressif au cours de ces dernières années. Ce recul s’explique principalement par les baisses de prix appliquées en 2012 et par le développement du marché des génériques. En 2012 [...]


EMA creates Healthcare Professionals’ Working Party

The European Medicines Agency has established a formal Healthcare Professionals’ Working Party (HCPWP) to further involve this group of stakeholders in its range of activities. The role of the HCPWP is to provide recommendations to the Agency on all matters of interest to healthcare professionals in relation to medicines. The creation of this working party [...]


FDA Draft Guidance: Medical Device Reporting for Manufacturers

This draft guidance document describes and explains the Food and Drug Administration’s (FDA, we, us) current regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events.1 These requirements are contained in our Medical Device Reporting (MDR) regulation at Title 21, Code of Federal Regulations (CFR), part 803, [...]

2013-08-01T17:49:07+00:0009.07.2013|Regulatory Affairs|

UK MHRA: Updates to GMP section: Risk based escalation to manage poor compliance

The GMDP Inspectorate has recently implemented a non-statutory process to take action in response to poor compliance which does not yet meet the threshold for consideration of adverse regulatory action. The Compliance Escalation process forms an extension of the existing RBI process, prior to consideration of regulatory action. The main aim of the process is [...]

2013-08-01T17:42:08+00:0005.07.2013|Regulatory Affairs|

Dr Ian Hudson appointed as the UK MHRA’s new Chief Executive

The Medicines and Healthcare Products Regulatory Agency (MHRA) today announced the appointment of Dr Ian Hudson as its Chief Executive. He will take up the post in September when current Chief Executive Sir Kent Woods steps down, after ten years with the agency. Dr Hudson is currently the MHRA’s Licensing Director, responsible for the majority of [...]

2013-08-01T17:34:18+00:0004.07.2013|Regulatory Affairs|

ENCePP guide on methodological standards in pharmacoepidemiology is revised

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance  (ENCePP), coordinated by the European Medicines Agency, has completed the second revision of the ENCePP guide on methodological standards in pharmacoepidemiology. This guide is a key tool in supporting high quality post-authorisation studies. It offers a comprehensive overview of methodological guidance for researchers in pharmacoepidemiology andpharmacovigilance and is internationally recognised as [...]

2016-12-11T18:40:36+00:0004.07.2013|Drug Development Strategy, Pharmacovigilance|

FDA partners internationally to protect consumers from fake online pharmacies

The Food and Drug Administration (FDA) participated last week in an international effort that took action against thousands of websites that illegally sell potentially dangerous prescription medicines to consumers, but many thousands more of these sites are still operating. FDA is committed to protecting consumers from these fake online pharmacies and developed BeSafeRx: Know Your [...]