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  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA to Revise Guideline on Quality of Inhaled Medical Products (30 March 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Starts Consultation on Quality of Inhaled Pharmaceutical Products The European Medicines Agency (EMA) has started a consultation on planned changes to its stance on the pharmaceutical quality of inhaled and nasal products. EMA published the concept paper to start bringing its guidance in line with changes in thinking about therapeutic equivalence since it released its cu...
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    EC Unveils Revised Guideline on Pharmaceutical Excipients

    The European Commission on Tuesday opened for public comment a revised guideline concerning the list of excipients, defined as any constituents of a medicinal product other than the active substance and the packaging material, which must be included on the labeling of medicines, as well as the way in which these excipients must be indicated.  The guideline’s revision, which the EC says reflects developments since 2003, includes a list of excipients which should be state...
  • Regulatory NewsRegulatory News

    EMA Revises Guideline on First-in-Human Trials

    The European Medicines Agency (EMA), in cooperation with the European Commission and the EU member states, on Tuesday proposed revisions to its 2007 guideline on first-in-human clinical trials as part of an effort to further improve the safety of participants as trial protocols become increasingly complex. The  revised guideline , which is open for public consultation until 28 February 2017, is intended to further assist sponsors in the transition from non-clinical to ea...
  • Regulatory NewsRegulatory News

    Amended ICH GCP Guideline Addresses Evolution of Trials Landscape

    The International Conference on Harmonization (ICH) has amended its good clinical practice (GCP) guideline with the aim of helping industry address the increasing scale, complexity and cost of clinical trials. The evolving use of technology and new risk management processes offer opportunities to increase efficiency, ICH says. The updated guideline is intended to provide a unified standard for the regulatory authorities in the EU, Japan, US, Canada and Switzerland to fa...
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    EMA Updates its Biosimilar Insulin Guideline

    The European Medicines Agency (EMA) has updated its guideline on the requirements for clinical and non-clinical development of biosimilar insulin products. The update expands the scope of the original document and gives additional detail on study design parameters. Biosimilar Medicinal Products in the EU EMA recently finalized its guideline on “similar biological medicinal products”—commonly referred to as biosimilars—which will enter into effect in April 2015. B...
  • Regulatory NewsRegulatory News

    EMA Finalizes Major Guideline on Biosimilars

    The European Medicines Agency (EMA) has finalized a long-awaited guideline containing new recommendations on how to bring "similar biological medicinal products"—also known as biosimilars—to market in the EU. Background EMA first released a draft update of the guideline, Similar Biological Medicinal Products , in early May 2013. The guideline was meant to update an October 2005 guideline on biosimilarity which officials said had become outdated. The new guidelin...
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    EMA, FDA Team Up to Propose Guideline on Pediatric Gaucher Disease

    US and EU regulators have come together to release an unusual joint proposal that they say will help speed up the development of new treatments affecting pediatric patients with Gaucher disease. Background Gaucher disease is a rare, inherited lysosomal storage disorder which affects patients by causing the buildup of lipids in cells and organs, such as the liver, spleen, kidneys and brain. It is thought that about 20,000 patients have Type I Gaucher disease in the US, a...
  • EMA Issues New Guideline on Controlling Disease Transmission Risks in Urine-Based Products

    The European Medicines Agency (EMA) is out with a new draft guideline intended for sponsors of human urine-based products, saying a standardized approach is needed to ensure that products are free from dangerous contaminants. As regulators explain in the guideline- on the adventitious agent safety of urine-derived medicinal products -human urine is used in several products, including human chorionic gonadoptropin (hCG), human menopausal gonadotropin or menotropin (HMG)...
  • EMA Updates Biosimilar Guideline to Account for Nuanced Development Approach

    The European Medicines Agency (EMA) has announced the release of a new biosimilars guideline that again looks to clarify the process by which biosimilars come to market, this time refining an earlier guideline in several areas. Background Generic products have long been an integral part of the pharmaceutical ecosystem. Starting in the 1980s, frameworks were set up around the world to allow for generic pharmaceutical companies to make chemical copies of existing drugs a...
  • EMA Releases New Guideline Meant to Clarify Process for Naming Drug Products

    Around the globe, healthcare product regulators have expressed an interest in-and occasionally concern with-naming conventions for brand-name pharmaceutical products. EU regulators are no exception to this rule, and announced this week that they have issued new revisions to a guideline regarding the acceptability of names for human medicines. Background While many consumers might consider branded pharmaceutical names a marketing tool-which they undoubtedly are-regulator...
  • New EMA Guideline on Depression Focused on Special Populations

    The European Medicines Agency (EMA) has announced the release of a new final guideline regarding the investigation of medicinal products intended to treat depression, providing a nuanced approach to treating depression in several subpopulations and bringing a two-year consultation process to a close. The guideline covers all products intended to treat Major Depressive Disorder (MDD) on a consistent basis, with a particular emphasis on treating major depressive episodes...
  • EMA Looks to Cut Down on Antibiotic Resistance through New Efficacy Guidelines

    The European Medicines Agency (EMA) has announced the release of a new draft guideline regarding the testing of veterinary antibiotics, with regulators saying the changes provide greater detail on their expectations for demonstrating efficacy relative to a targeted microorganism. The guideline is in part intended to cut down on rates of increasing antimicrobial resistance, EMA wrote in an accompanying statement, with the theory being that ineffective drugs only serve to ...