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  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EU Trade Groups Propose Criteria for Deciding EMA’s New Home (2 March 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. European Trade Groups Propose Criteria for Deciding New Home of EMA European biopharma trade groups have jointly set out criteria for deciding on the new home of the European Medicines Agency (EMA). The three trade groups detailed their desire for the selection process to consider six essential criteria in a letter to a high-ranking health official at the European Commission...
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    European Regulatory Roundup: Dutch Regulator Revamps Drug Nomenclature Policy (22 October 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Dutch Regulator Overhauls Policy on Nomenclature of Medicines The Medicines Evaluation Board (MEB) in the Netherlands has completely revised its policy on nomenclature covering human medicinal products and is enforcing the changes with immediate effect. Out of all the revisions included in the new nomenclature policy, MEB has picked out six that it sees as the most importan...
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    FDA Finalizes Policy Meant to Limit Use of Antibiotics in Farm Animals

    The US Food and Drug Administration (FDA) has released a long-anticipated final rule meant to limit the use of antibiotics in food-producing animals in order to limit the spread of antibiotic-resistant bacteria. The rule, known as the Veterinary Feed Directive (VFD) , has been amended to require veterinary antibiotics to be prescribed by a veterinarian "within the context of a veterinarian-client-patient relationship (VCPR)," FDA explained in an accompanying press s...
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    In Fight Against Antimicrobial Resistance, EMA Looks to Public for Help

    The European Medicines Agency (EMA) is looking for feedback on a new set of principles for setting the defined daily dose (DDDA) and defined course dose (DCDA) for antimicrobial products used in animals. The guideline was drafted by the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) committee, and is intended to establish standards for setting DDDA and DCDA amounts for veterinary antimicrobial products. The consultation is part of an ongoing...
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    EU Considers Major Revisions to Veterinary Medicines Regulations

    The European Parliament is considering major changes to how veterinary medical products are regulated in the EU. At the upcoming meeting of the Environment, Public Health and Food Safety (ENVI) committee on 18 March 2015, members will discuss a proposal for a new regulation which is intended to overhaul the regulation of veterinary medicines and streamline the European market for veterinary medicinal products. Background Veterinary and human medicines regulations in th...
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    EMA Releases new Policies Meant to Combat Antimicrobial Resistance

    As part of its efforts to combat antimicrobial resistance (AMR), the European Medicines Agency (EMA) has issued two draft guidelines related to the use of antimicrobial agents in veterinary medicinal products. Background Resistance to antimicrobials is not a new phenomenon. Scientists have observed AMR as far back as the late 1930s, following the discovery and mass use of sulfanilamide. Alexander Fleming, the scientist who discovered penicillin, warned of the risk...
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    FDA's Veterinary Regulators Eye Dozens of Policy Changes in 2015

    The US Food and Drug Administration's (FDA) veterinary regulatory division, the Center for Veterinary Medicine (CVM), plans to release 31 new or updated policies in 2015, it has confirmed. In a notice posted on FDA's website last week , CVM announced top-level details about which guidance documents it plans to release in the coming year. Guidance documents are non-binding expressions of policy, and indicate how FDA wants members of the life science industry to comply wi...
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    EMA Touts Big Year for Veterinary Products

    The European Medicines Agency (EMA) recommended 20 new veterinary medicines for approval in 2014, the highest number in the past five years, according to data provided by the regulator. The agency also boasts that it received 29 requests for classification of medicines intended for rare diseases or species with a small population, the most the agency has seen in a single year. Addressing Rare Diseases in Animals In 2009, EMA’s Committee for Medicinal Products for Vete...
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    FDA in Wider Crackdown Against Marketers of Drugs Meant for Horses

    For the second time in as many weeks, the US Food and Drug Administration (FDA) is warning marketers of veterinary products, saying several are promoting their equine ulcer drugs without first having obtained FDA approval. Background Last week FDA sent three Warning Letters ( 1 , 2 , 3 ), all to marketers of equine ulcer drugs, saying their products had been promoted in ways that caused them to be "intended for use in the mitigation, treatment or prevention of disease...
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    Even Pharmaceutical Marketing for Dogs can be Improper, FDA Says in Warning Letter

    When the US Food and Drug Administration (FDA) goes after pharmaceutical companies for violating federal marketing regulations, it usually goes after makers of pharmaceuticals for humans. But as a recent and rare Warning Letter illustrates, sometimes veterinary companies fall under the agency's scrutiny as well. In a 2 April 2014 letter to AB Science , a French pharmaceutical manufacturer, FDA veterinary regulators cited the company for allegedly marketing its veterinar...
  • FDA's New Veterinary Antibiotics Strategy Yields Early Results

    Several months after first launching a new regulatory approach intended to voluntarily limit the prescribing of non-essential antibiotics in food-producing animals, the US Food and Drug Administration (FDA) is already seeing success. Background FDA's antibiotic use policy  first began to take shape  in the 1970s, and in recent years has been subject to intense scrutiny from outside  advocates ,  former FDA officials ,  government investigators ,...
  • FDA's Veterinary Division Plans to Release Dozens of Regulatory Guidances in 2014

    US veterinary product regulators from the Center for Veterinary Medicine (CVM) have released the first of the US Food and Drug Administration's (FDA) guidance agendas for the year, highlighting a range of policy initiatives they aim to undertake in the coming months. FDA, CVM's parent organization, is in the practice of releasing so-called "guidance agendas" at the beginning of each year, and sometimes updating it several times throughout the year. The intent is to allow...