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  • Regulatory NewsRegulatory News

    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...
  • FDA Finds 'Significant' Problems at API Manufacturer

    Two facilities maintained and run by a manufacturer of active pharmaceutical ingredients (API) exhibited serious violations of current good manufacturing practices (CGMPs), the US Food and Drug Administration (FDA) said in a Warning Letter issued this week . The API manufacturer, CBS Chem , was subject to two separate inspections in 2013, one for its facility in Tempe, AZ and another for its Tuen Min, Hong Kong facility. Arizona While FDA inspectors alleged that both...
  • Corrected: CFDA Issues API Export Instructions to Provinces

    China's Food and Drug Administration (CFDA) last week issued instructions to Chinese provinces regarding the requirements for certifying active pharmaceutical ingredient manufacturers for the right to export their products to the European Union (EU) as of 2 July 2013. Editor's Note: A previous iteration of this article said that the ingredients in question were excipients. They are in fact APIs. We regret the error. The announcement, made on 7 May 2013 and issued w...
  • Final FDA Guidance Clarifies Regulatory Classification for Novel Formulation of Pharmaceuticals

    The US Food and Drug Administration (FDA) has released a new final guidance document regarding how regulators plan to classify pharmaceutical products that are made of solid-state co-crystals, a novel formulation for drugs that raises some equally novel regulatory issues. Background Pharmaceutical products are generally comprised of two components: An active ingredient (API) and an excipient, which serves to enhance the product's qualities, including bioavailability, ta...
  • China Rule Puts Primary Responsibility for Excipient Quality on Drug Manufacturers

    Pharmaceutical manufacturers will bear primary responsibility for assuring the quality of the excipients used in their products according to a new regulation announced by China's State Food and Drug Administration (SFDA) at a press conference 1 August 2012.  Under the regulation, manufacturers will be required to establish an excipient quality management system, enter into quality agreements with excipient suppliers and implement supplier audits. The regulation f...
  • USP Releases Overhaul of Impurities Testing Standards

    • 24 May 2012
    • By
    The US Pharmacopeia (USP), a standards-setting body for the content of medicines, has released two new standards to limit the presence of elemental impurities in medicinal products. The standards, <232> Elemental Impurities - Limits and <233> Elemental Impurities - Procedures , outline procedures on how to detect common impurities and sets limits on the presence of impurities to protect consumers from exposure. "Elemental impurities can occur naturally, b...
  • Brazil: New Rules For Excipients Published

    The Board of Directors for Brazil's national regulatory agency, ANVISA, agreed on 24 April to the publication of a proposed new regulation for the Certificate of Good Manufacturing Practices for Pharmaceutical Excipients. Once published in the Official Gazette (DOU), the proposal will be open for comment for 60 days.  The excipient proposal will test a new system that will permit comments to be filed electronically using a program developed by the Ministry of H...