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  • Regulatory NewsRegulatory News

    3D Bio-Printed Products: ICMRA Members Discuss Potential Regulatory Frameworks

    As part of a project on emerging technologies, six regulators involved in the International Coalition of Medicines Regulatory Authorities (ICMRA) recently published a case study delving into the challenges of regulating 3D bio-printed products. In this hypothetical case, the regulators evaluated 3D bio-printed knee meniscus tissue and discussed how they would tackle similar products. The case study was conducted by Australia’s Therapeutic Goods Administration (TGA), Bra...
  • Regulatory NewsRegulatory News

    Drug Regulators Look to Harmonize How They Tackle Innovation

    The International Coalition of Medicines Regulatory Authorities (ICMRA) recently released a report on how various regulators worldwide are working together to better identify and address future regulatory challenges posed by new categories of therapeutics, like cell and gene therapies, and new tools for drug development, such as artificial intelligence (AI). The report, which is part of a wider effort to reduce duplicative work and increase harmonization among drug regu...
  • Regulatory NewsRegulatory News

    ICMRA Looks to Make Track-and-Trace Systems Globally Interoperable

    The International Coalition of Medicines Regulatory Authorities (ICMRA) has its eye on aligning existing and planned track and trace systems worldwide, with a focus on interoperability as many of the existing and planned systems were designed with a national or regional focus. Track and trace systems, which have been or are currently being implemented in the US, EU, Turkey, Argentina, Canada, Italy and Japan, are used to help ensure falsified, counterfeit or otherwi...
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    European Regulatory Roundup: EMA Maps International Regulatory Coordination (12 January 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Maps International Regulatory Coordination Initiatives to Show Overlaps, Gaps The European Medicines Agency (EMA) has mapped cooperative regulatory initiatives to better understand how and where international peers are working together. EMA found there were a “myriad of initiatives but no strategic coordination,” prompting it to warn regulators are duplicating effo...
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    EMA Report Emphasizes Need for Coordinating International Regulatory Initiatives

    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. EMA says the report was developed on behalf of the International Coalition of Medicines Regulatory Authorities (ICMRA) to "provide a general overview of multi-project initiatives in which multiple regulators were involved." Backgro...
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    Updated: FDA and EMA Progressing Toward Mutual Recognition of GMP Inspections

    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. The news of the progress comes as both agencies continue to observe their counterparts’ inspections on an ongoing basis. Emer Cooke, head of international affairs at the EMA, told Focus in an exclusive interview that both sides have “progressed quicker than w...
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    Cash-Strapped MHRA Looks to Stay Flexible

    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. “Funding for devices regulation is at half the level of what it was in 2003 in real terms; and while a number of efficiency measures have been t...
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    FDA, International Regulators Banding Together to Fight Ebola

    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. In a 4 September 2014 statement, a broad coalition of regulatory agencies under the umbrella of the World Health Organization's (WHO) International Coalition of Medicines Regulatory Authorities (ICMRA) said they would be working together "to find innovative solutions to facilitate evaluation ...
  • Global Healthcare Product Regulators in Talks to Form New Regulatory Supergroup

    US and international regulators are reportedly working to form a new global regulatory organization focused on leveraging and sharing resources and information among regulatory authorities. The existence of the organization was announced this week in London by US Food and Drug Administration (FDA) Commissioner Margaret Hamburg, who was attending the Medicines and Healthcare Products Regulatory Agency's (MHRA) ninth Annual Lecture. "Regulators around the world have begun...