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  • RoundupsRoundups

    Euro Roundup: HRPA posts 5-year plan as it emerges from ‘twin challenges’ of Brexit and COVID

    Ireland’s Health Products Regulatory Authority (HPRA) has published its strategic plan for 2021 to 2025. HPRA set out five goals intended to help it emerge from the “twin challenges of Brexit and COVID-19” and deliver better outcomes for people and animals.   The five goals are titled health system partnerships, progressive regulation, communication and engagement, enabling innovation and great people, great processes. By engaging in activities that further those goals...
  • RoundupsRoundups

    Euro Roundup: Northern Ireland warns of Brexit border strain for pharmaceuticals

    The Minister for Health in Northern Ireland has warned “additional bureaucracy and management” created by Brexit is putting a strain on a team that advises on medicines and pharmaceutical issues.   Robin Swann, the politician in charge of health in Northern Ireland, framed the problem as a result of the solution Brexit negotiators came up with to avoid the creation of a hard border on the island of Ireland. The solution, the Northern Ireland Protocol, leaves the jurisd...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Ireland Starts Consultation on Biosimilar Policy (17 August 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU Regulatory news. Ireland Starts Consultation on Biosimilar Policy, Immediately Receives Pushback From Industry Ireland has started a consultation on how to increase access to biosimilars. The delayed document calls for feedback on pharmacy-led substitution of biosimilars, quotas for use of biologic copycats and other ways to increase uptake, although doubts remain about whether the gove...
  • Feature ArticlesFeature Articles

    Out of Africa: Six Regulatory Articles that Span the Continent

    Africa has a rapidly growing populace and demand for safe, effective and trusted medical products. Different geographic areas of Africa are developing their medical products submission and approval systems at varying rates of sophistication dependent, in part, on internal resources. Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southe...
  • Feature ArticlesFeature Articles

    Northern Africa: Regulatory Submission Considerations for the Region

    Northern Africa is an emerging region that presents a unique and diverse set of regulatory considerations . Through the World Health Organization (WHO), US Food and Drug Administration (FDA) and European Medicines Agency (EMA), sponsors have been able to leverage the regulatory review and approval of medicines in International Conference on Harmonization (ICH) countries to access drugs to treat major diseases. While some of these regulatory pathways, including the...
  • Regulatory NewsRegulatory News

    Ireland Considers Switching 12 Medicines to OTC Status

    Ireland's Health Products Regulatory Authority (HPRA) has published a list of twelve active ingredients (or combinations of ingredients) that are currently classified as prescription-only medicines (POM) which it believes could safely be made available to consumers over-the-counter (OTC). There are currently 34 drugs approved in Ireland that contain one of the ingredients included on the list, including medicines for the treatment of migraine, acid reflux, hay fever, ...
  • Ireland Implements Reference Pricing to Boost Use of Generics

    The Health (Pricing and Supply of Medical Goods) Act of 2013, enacted in Ireland on 28 May 2013, introduces a system of generic substitution and reference pricing for medicinal products in Ireland. The Irish Medicines Board (IMB) has published guidance detailing its responsibilities under the Act and the process for creating the mandated List of Interchangeable Medicines. Reference pricing involves the setting of a common reimbursement price, or reference price, for a...
  • Ireland, FDA's Legislative Director, Transitions to new Advisory Role Within Agency

    The US Food and Drug Administration's (FDA) top legislative official, Jeanne Ireland , will leave her current post and assume a new role as senior advisor to Commissioner Margaret Hamburg, the commissioner wrote in an email to FDA staff on 1 November. Ireland served since 2009 as the head of the Office of Legislation (OL), an office charged with coordinating legislation and working with legislators to defend the agency, advocate on its behalf and advise members of Congr...
  • New Rules to Voluntarily Restrict Prescription Drug and Device Marketing in Ireland

    Pharmaceutical and medical devices industries doing business in Ireland may soon find it more difficult to market their products under new guidance developed by the Irish Medical Council aimed at redefining the terms of acceptable conduct between doctors and members of industry. The guidance, a supplement to earlier guidance on the same topic, is specifically aimed at reducing real or perceived conflicts of interest, the majority of which are caused by gifts and othe...
  • Irish Developer Gets FDA Clearance for Device Uses

    • 31 August 2012
    The U.S. Food and Drug Administration has granted clearance of new uses for a gastroenterological system from Ireland. Crospon, based in Galway, Ireland, made the announcement and said the EndoFLIP system can be marketed in the U.S. for gastroenterology applications. The newly cleared Barostat software option extends current uses for the system beyond measurements taken during gastric band and sleeve gastrectomy bariatric surgery procedures, according to a company releas...
  • FDA Fires Back at Legislative Critics, Blames Manufacturers for Drug Shortages

    The US Food and Drug Administration (FDA) is seeking to distance itself from a June 2012 report by the House Oversight Committee claiming the regulatory agency is the root cause of drug shortages currently plaguing dozens of pharmaceutical products. The original report, FDA's Contribution to the Drug Shortage Crisis , claimed FDA had "largely sparked" shortages through its increased reliance on facility inspections and monitoring of regulatory compliance activities....
  • Irish Medicines Board Announces Transition to Fully Electronic Submission System

    • 14 May 2012
    The Irish Medicines Board (IMB) is announcing its adherence to a 2005 agreement between the Heads of Medicines Agencies to transition to a fully electronic system for submitting applications, including the electronic Common Technical Document (eCTD) and Non-eCTD electronic Submissions (NeeS). IMB said in a statement the transition confers several advantages, including reduced costs, consistency of applications and information viewed across agencies, improved lifecycle ma...