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  • Regulatory NewsRegulatory News

    EMA Updates on 3Rs Guideline Review

    The European Medicines Agency (EMA) on Tuesday published a report on actions taken to update its guidelines following a review of 3Rs, or replacement, reduction and refinement, principles to reduce the need for animal testing of medicinal products.   In 2014, EMA’s Committee for Medicinal Products for Human Use (CHMP) and Committee for Medicinal Products for Veterinary Use (CVMP) launched a review to update their guidelines to ensure they align with 3Rs best practices....
  • Regulatory NewsRegulatory News

    ICH Advances Q&A Document on Microsampling

    The International Conference for Harmonization (ICH) on Thursday announced its members had adopted a draft version of a question and answers (Q&A) document intended to provide clarification on the use of microsampling in study animals. Microsampling is the process of using minimal amounts of blood (less than 50 microliters (μl) per ICH guidelines) drawn for testing purposes. Specifically, the Q&A document provides insight on the types of pharmaceuticals microsampl...