• Regulatory NewsRegulatory News

    EU reference labs: Commission adopts implementing acts

    A new set of implementing acts adopted by the European Commission outlines what EU reference laboratories need to consider in order to serve their customers. The regulations address issues such as how to ensure the labs have proper training and resources to handle workloads as well as how to ensure pricing transparency.   On 17 June, the Commission published two regulations on EU reference labs that may be used by notified bodies and member states to give technical ass...
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    EMA clarifies application of GMP principles to ATMP starting materials

    The European Medicines Agency (EMA) issued a question-and-answer guidance on 23 April addressing how good manufacturing practices (GMP) principles should be applied to starting materials for advanced therapy medicinal products (ATMPs) of biological origin.   EMA said that the Q&A is not meant to set new GMP requirements but rather to give guidance on “what principles of GMP mean and how to implement them.” The guideline describes “minimal” requirements in the fields of...
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    PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is seeking comments on revisions to two parts of its GMP Guide (Annex 2A and Annex 2B) that deal with the manufacture of advanced therapy medicinal products (ATMPs) and biological medicinal substances and products for human use. PIC/S explains that draft Annex 2A accounts for international developments in the regulation of ATMPs, with particular attention to the European Commission guideline on GMP for ATMPs, whi...
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    CDRH to Review Materials Used in Medical Devices

    Following recent high-profile safety issues related to materials used in implantable and insertable medical devices, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren on Friday announced plans to improve the agency’s approach to evaluating material safety and biocompatibility.   “Modernizing the regulatory framework pertaining to the FDA’s review of medical device materials requi...
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    UK’s NIBSC Updates on No-Deal Brexit Plans

    With less than a month remaining before the UK exits the EU, the UK’s National Institute for Biological Standards and Control (NIBSC) on Thursday provided an update in the event of a no-deal Brexit scenario.   In the update, the NIBSC, which produces and distributes a wide range of biological reference materials and functions as the UK’s official medicines control laboratory for biological products, says that while a Brexit deal “remains the Government’s top priority”...
  • Feature ArticlesFeature Articles

    The Life and Times of a Promotional Claims Compendium

    This article discusses developing a "promotional claims compendium" to review pharmaceutical marketing materials. It highlights the advantages of using a compendium for a variety of purposes and the potential value it could bring to not only the review team, but the entire organization. Introduction Reviewing promotional materials is a necessity in the pharmaceutical industry. Rules and regulations implemented by the US Food and Drug Administration (FDA) regarding pro...
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    UK Strategy for Pharmacopeial Quality Standards for Biologics: MHRA Discusses Comments

    Trade associations, manufacturers, academia and researchers have offered their opinions on the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) draft strategy for crafting pharmacopeial standards for biologics, according to a report issued Monday. In general, MHRA says the responses supported the value of standardization, and found that areas where standards could add value included providing guidance and ensuring consistency for product characterizat...
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    WHO Will Hold Off on Using Biological Qualifiers for Biosimilars

    No consensus has been reached on whether the World Health Organization (WHO) should continue with its biological qualifier proposal in assigning international nonproprietary names for biosimilars, and WHO says it "will not be proceeding with this at present," according to an October report. The US Biosimilars Council praised the WHO move , which follows the US Food and Drug Administration’s (FDA) use of a system in which biosimilar nonproprietary names come with a f...
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    Guest Editorial: Does Nutrition Have a Role in Disease Management?

    This editorial is meant to encourage discussion and thinking about the value of diet and nutrition in the management of disease and a regulatory framework that would be useful in the US to protect public health and provide benefit to individuals who live with chronic disease or an increased risk of such diseases. Introduction The current regulatory approach, with respect to food and nutrition, tends to categorize individuals as consumers or patients and yet these stat...
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    TGA Consults on Biological Naming

    Australia's Therapeutic Goods Administration (TGA) on Friday launched a public consultation to gather feedback on proposals for potential biological naming systems, including options for EU- or US-aligned systems. According to TGA, the need for a naming convention that can differentiate biologics from their biosimilar counterparts stems from concerns that adverse events could occur when switching patients between products, though the agency says there has been little evi...
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    FDA Warns Phototherapy Device Maker for Quality System Issues

    The US Food and Drug Administration (FDA) has warned device maker National Biological Corporation for quality systems issues following a two-week inspection of the firm's Beachwood, OH facility last March. The warning letter, dated 11 July 2017, details eight violations, including validation, recordkeeping and equipment calibration issues. FDA also says the company failed to notify it within 10 days of issuing a recall for one of its devices, and did not do so until the...
  • Feature ArticlesFeature Articles

    Biological Products and Biosimilars: Global Naming Debate

    This article presents the contrasting views and continuing debate among health authorities in Australia, Canada, Europe, Japan and the US as well as industry experts regarding conventions for naming biological products and biosimilars. It discusses the World Health Organization's (WHO's) proposal for naming and the importance of a clear distinction between the drugs to avoid confusion and ensure patient safety. Introduction Conventions and regulations for naming biosi...