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  • Regulatory NewsRegulatory News

    EMA Issues Guidance on Clarification Meetings

    The European Medicines Agency (EMA) is looking to increase transparency between its committees and pharmaceutical companies under a new guideline that went into effect in February 2015. The guideline, EMA/636600/2014, details procedures regarding clarification meetings in response to questions raised by the agency during the review of a product using the centralized procedure. Clarifying Objections EMA believes increasing transparency between the agency and applicant...
  • Regulatory NewsRegulatory News

    EU's First Stem Cell Treatment Recommended by EMA

    A major milestone in stem cell therapy was reached in December 2014 when a European Medicines Agency (EMA) committee recommended the conditional approval of Holoclar, the first stem-cell product to be recommended for approval in the EU. Background Holocloar, developed by Chiesi Farmaceutici S.p.A. and Holostem Terapie Avanzate, is an advanced-therapy medicinal product (ATMP) granted orphan designation for limbal stem cell deficiency (LSCD) caused by chemical or physic...
  • EMA Shines a Light into its Black Boxes of Regulatory: Its Review Committee Meetings

    US regulatory professionals have long benefited from meeting transcripts and other open meeting requirements that have meant that the inner workings and decisions of the US Food and Drug Administration's (FDA) various advisory committees are available for debate and dissection. Background This can be extremely useful for a range of stakeholders. Regulatory professionals seeking approval for similar products can tailor their applications to address the needs of committee...
  • Following FDA, EMA Launches Review of Emergency Contraceptive Effectiveness

    EU regulators have announced they are initiating a review of emergency contraceptives like Teva's Plan B One-Step following reports that the drug may lose effectiveness in women who are overweight or obese. Background In November 2013, Mother Jones broke the news that HRA Pharma, manufacturer of the emergency contraceptive Norlevo, was updating its packaging to reflect new evidence that the drug begins to lose effectiveness in overweight women, and may lose all effect...
  • EU Regulators Claim Diabetes Medicines Clear of Safety Fears, but Data Key to Finding

    Diabetes drugs of the GLP-1 and DPP-4 class have recently come under intense scrutiny by regulators on both sides of the Atlantic Ocean, with both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) expressing strong concerns that the pancreatic risks associated with the drug might well outweigh their benefits. Now, however, EU regulators have reaffirmed their positive benefit-risk assessment, saying that no new concerns could be identified b...
  • EMA Recommends Limiting Indication of Cilostazol-Containing Medicines Because of Risks

    A warning issued by the European Medicines Agency (EMA) on 22 March 2013 cautions healthcare providers and the public not to use cilostazol-containing medicines to treat intermittent claudication, a condition in which poor blood flow to the legs results in pain and difficulty walking, due to the heightened risks of serious bleeding and adverse cardiovascular events. EMA-approved medicines containing cilostazol include Pletal and Ekistol, both phosphodiesterase type 3 inh...
  • Centralized Procedure to see Simplified Submission Process, Says EMA

    The European Medicines Agency (EMA) has announced that it has simplified the process by which marketing authorization applications (MAAs) are submitted to the agency, reducing the number of applications that marketing authorization holders (MAHs) need to submit during the centralized procedure. The changes comes just as EU regulators are in the midst of implementing the pharmacovigilance legislation, an EU-wide set of requirements intended to make it easier to track and ...
  • EMA Announces Huge Overhaul of Operations, Processes

    The European Medicines Agency (EMA) is preparing to reorganize its operations, processes and offices in 2013, it has announced. In a statement released on its website on 19 December 2012, the agency said the overhaul will be "focused on increasing the efficiency of its scientific activities and information- and communication-technology operations." A particular focus will be placed on how it supports the mission of its scientific committees-the Committee for Medicinal P...
  • CHMP Appoints New Vice-Chair

    The European Medicines Agency (EMA) has appointed Ian Hudson as the new vice-chair of its Committee for Medicinal Products for Human Use (CHMP) after its previous vice-chair was appointed to the position of chair of the CHMP. Hudson ( PDF ) has been a member of the CHMP since 2004, and has also served on the Paediatric Committee (PDCO), the Committee for Proprietary Medicinal Products (CPMP) and the guideline consistency group. Outside of EMA's advisory groups, he curr...
  • After Failures, EMA Calls for Overhaul of Existing Obesity Treatment Guidance

    A new concept paper released by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) seeks to establish an updated framework for anti-obesity and weight control drug products. In its 1 October concept paper, " Concept paper on the need for revision of the guideline of medical products used in weight control ," CHMP looks to a November 2007 guideline on weight control, noting that two weight control products have been pulled from the marke...
  • CHMP Elects New Leader after Atypical Transition

    The European Medicines Agency (EMA), currently in the midst of a number of changes in committee staff, has elected Thomas Salmonson as the new chair of its influential Committee for Medicinal Products for Human Use (CHMP). CHMP's transition has been anything but typical. Its previous chair, Eric Abadie, resigned abruptly in April 2012 after being linked to a scandal involving then-French-regulator Afssaps's handling of the anti-diabetes drug Mediator . French regu...
  • CHMP Recommends EU's First Gene Therapy Product

    The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended for use the first gene therpy product in the European Union, regulators said Friday, 20 July. Glybera (alipogene tiparvovec), manufactured by UniQure, is intended to treat lipoprotein lipase deficiency-an ultra-rare disease that renders patients unable to break down dietary fat. Current therapies for the disease are dietary oriented, with patients required to ea...