Search Results for Swissmedic

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European Regulatory Roundup: EMA Revises Pharmacovigilance Guideline After Danish Agency Spots 'Big Problem' (10 August 2017) By Nick Paul Taylor - Published 10 August 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: pharmacovigilance, DKMA, Swissmedic

European Regulatory Roundup: EU Device Regulations Come Into Force; Swissmedic Clarifies Pharmacovigilance Process (1 June 2017) By Nick Paul Taylor - Published 01 June 2017

The European Union medical device and in-vitro diagnostic (IVD) regulations have come into force. The passing of the date marks the start of the phased, multi-year introductions of requirements set out in the two documents.

Categories: Europe, EC, EMA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Postmarket surveillance, Submission and registration

Tags: European Regulatory Roundup, Regulatory Roundup, EU Regulatory Roundup, Brexit, MDR, IVDR, Swissmedic, Pharmacovigilance,

Swissmedic Touts 2016 Performance: 42 New Approvals By Michael Mezher - Published 30 May 2017

In its annual report released Tuesday, Swiss drug regulator Swissmedic says it outpaced the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) in approving new drugs in 2016, in part due to the agency's new fast-track procedure.

Categories: News, Europe, Biologics and biotechnology, Drugs, Postmarket surveillance, Submission and registration

Tags: Swissmedic, new active substance, New chemical entity, fast track

Swissmedic To Prioritize Electronic Adverse Events Reports By Michael Mezher - Published 30 January 2017

Swiss drug regulator Swissmedic on Monday announced it will begin prioritizing the review of electronically submitted adverse drug reaction (ADR) reports in light of a recent influx of such reports.

Categories: News, Europe, Drugs, Postmarket surveillance

Tags: Swissmedic, Adverse Drug Reaction, ADR, ELViS, E2B Gateway

European Regulatory Roundup: Swissmedic Clarifies Stance on EC Certificates for Devices (5 January 2016) By Nick Paul Taylor - Published 05 January 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Swissmedic, European Regulatory Roundup, notified bodies, Braille

European Regulatory Roundup: UK Advances Bill to Stop Price Spikes on Generic Drugs (27 October 2016) By Nick Paul Taylor - Published 27 October 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy

Tags: drug price increases, UK pharmaceutical legislation, Swissmedic

UK’s MHRA and Swissmedic Pledge Closer Collaboration By Zachary Brennan - Published 11 October 2016

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday announced it will forge closer ties with its Swiss counterpart, Swissmedic, via a Memorandum of Understanding (MoU) signed as part of the 11th Summit of the Heads of Medicines Regulatory Agencies in Interlaken, Switzerland.

Categories: News, Europe, EMA, ICH, MHRA, WHO, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Swissmedic, regulatory collaboration, Heads of Medicines Regulatory Agencies

Swissmedic Sees Spike in Adverse Event Reports for Third Straight Year By Zachary Brennan - Published 06 June 2016

In a new report on its work in 2015, Switzerland’s drug and medical device regulator Swissmedic reported a sharp rise in the number of suspected adverse drug reaction (ADR) reports received (7.1% increase from 2014 and a more than 30% increase from 2013), due mainly to an increased volume of reports from industry.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Medical Devices, Postmarket surveillance

Tags: Swissmedic, adverse event reports, European drug regulators, Swissmedic

Seven Pharmaceutical Regulators and NIH Collaborate to Build Drug Ingredient Database By Zachary Brennan - Published 20 April 2016

Drug regulators from the US, Europe, Canada, France, Netherlands, Germany and Switzerland are attempting to build a database of substances used in medicinal products to ease the exchange of such information.

Categories: News, Canada, Europe, US, EMA, FDA, Health Canada, ISO, WHO, Active pharmaceutical ingredients, Compliance, Crisis management, Postmarket surveillance, Quality

Tags: API database, ANSM, Swissmedic, ICH, NCATS

European Regulatory Roundup: EMA Proposes Major Changes to Risk Management (3 March 2016) By Nick Paul Taylor - Published 03 March 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Clinical, Drugs, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: good pharmacovigilance practices, NICE, Cancer Drugs Fund, Swissmedic

European Regulatory Roundup: Swissmedic Backtracks on ‘Cumbersome’ New Requirements (7 January 2016) By Nick Paul Taylor - Published 07 January 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Clinical, Compliance, Drugs, Government affairs, Research and development

Tags: EMA, Swissmedic, clinical trials

European Regulatory Roundup: EMA Calls for More Research Into Autism Diagnostic Tools (10 December 2015) By Nick Paul Taylor - Published 10 December 2015

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Ethics, Government affairs, In vitro diagnostics, Medical Devices, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: antimicrobial wastewater, EMA, autism, immuno-oncology, Swissmedic

Swiss Regulators Approve Ebola Vaccine Trial Meant to Protect Medical Volunteers By Louise Zornoza, RegLink News - Published 29 October 2014

Swiss healthcare product regulator Swissmedic has approved an application to start a clinical trial for an experimental Ebola vaccine at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, the regulator announced on 27 October 2014.

Categories: News, Europe, Clinical

Tags: Ebola, Swissmedic, World Health Organization, WHO

Health Canada, SwissMedic Join ICH as Steering Committee Members By Alexander Gaffney, RAC - Published 11 July 2014

The International Conference on Harmonization (ICH), the influential international pharmaceutical regulatory harmonization body, has elected to add two new regulators to its Steering Committee, the group has announced.

Categories: News, Japan, Canada, Europe, US, ICH, Drugs

Tags: ICH Steering Committee, ICH Meeting, ICH Update, SwissMedic, Regulatory Harmonization

Italian, Swiss, Spanish Regulators Ban Sale of Novartis Flu Vaccines By Alexander Gaffney, RF News Editor - Published 26 October 2012

Tags: AEMPS, SwissMedic, AIFA, Flaud, Agrippal, Vaccine, Influenza, Flu, Novartis, Latest News