Search Results for ICMRA

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ICMRA Looks to Make Track-and-Trace Systems Globally Interoperable By Zachary Brennan - Published 11 January 2018

The International Coalition of Medicines Regulatory Authorities (ICMRA) is focusing on aligning existing and planned track and trace systems worldwide, with an eye toward interoperability as many of the existing and planned systems were designed with a national or regional focus.

Categories: News, Asia, Europe, US, EMA, FDA, MHRA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Quality, Regulatory intelligence

Tags: ICMRA, track and trace, interoperability

European Regulatory Roundup: EMA Maps International Regulatory Coordination (12 January 2017) By Nick Paul Taylor - Published 12 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, Medical Devices

Tags: regulatory harmonization, ICMRA, Bayer, biologic quality standards

EMA Report Emphasizes Need for Coordinating International Regulatory Initiatives By Michael Mezher - Published 13 October 2016

The European Medicines Agency (EMA) on Thursday released what it says is the first comprehensive overview of international regulatory initiatives, calling attention to the need for greater coordination across international regulatory efforts.

Categories: News, EMA, Biologics and biotechnology, Drugs

Tags: ICMRA, International Coalition of Medicines Regulatory Authorities

Updated: FDA and EMA Progressing Toward Mutual Recognition of GMP Inspections By Zachary Brennan - Published 29 June 2016

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) are making significant progress toward mutually recognizing each other’s good manufacturing practice (GMP) pharmaceutical inspections.

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, US, Anvisa, EMA, FDA, ICH, MHRA, TGA, WHO, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: ICMRA, GMP inspections, mutual recognition, FDA and EMA relationship

Cash-Strapped MHRA Looks to Stay Flexible By Zachary Brennan - Published 27 April 2016

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released its business plan for 2016-17, warning of serious financial troubles, particularly as funding for the regulation of medical devices has declined over the past decade and as it's losing revenue from industry because of changes at the EU level.

Categories: News, Europe, EC, EMA, IMDRF, MHRA, NICE, WHO, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: MHRA funding, Brexit, CAMD, ICMRA, IMDRF

FDA, International Regulators Banding Together to Fight Ebola By Alexander Gaffney, RAC - Published 05 September 2014

Global regulators are banding together in the hopes of accelerating new therapies to treat a large and growing outbreak of the Ebola virus, a type of highly fatal hemorrhagic fever.

Categories: News, CFDA, EMA, FDA, MHLW, MHRA, PMDA, TGA, WHO

Tags: Ebola, ICMRA, WHO

Global Healthcare Product Regulators in Talks to Form New Regulatory Supergroup By Alexander Gaffney, RAC - Published 12 March 2014

Categories: FDA

Tags: ICMRA, Speech, Latest News, Hamburg