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  • Regulatory NewsRegulatory News

    ICH recaps progress made over past year, charts new topics

    The International Council for Harmonisation (ICH) announced that “significant milestones” were reached over the past year, including the adoption of the widely anticipated guideline on general considerations for clinical studies and the release of question-and-answer guidelines related to the electronic Common Technical Document (eCTD).   Other accomplishments ICH cited in a recent summary of a mid-November virtual meeting include the advancement of a guideline on qu...
  • Regulatory NewsRegulatory News

    ICH announces new data exchange with SNOMED to promote drug safety

    The International Council for Harmonization (ICH) announced on 29 April the release of its first set of data maps with SNOMED International that facilitates the exchange of adverse event reports and other important epidemiologic information between regulators and researchers.   This release of the maps is the first deliverable of an agreement between SNOMED International and ICH that aims to promote drug safety. The ICH Medical Dictionary for Regulatory Activities (...
  • Regulatory NewsRegulatory News

    Updated: ICH Updates on MedDRA, New Members and Guidelines

    The International Council for Harmonisation (ICH) on Thursday provided guidance and other updates, inaddition to news on developments for the Medical Dictionary for Regulatory Activities (MedDRA), following a recent meeting of the MedDRA management committee in Geneva, Switzerland. MedDRA was initially developed by ICH in the late 1990s to provide standardized medical terminology for regulatory purposes and is available at no cost to regulators and to drugmakers on a sli...
  • Regulatory NewsRegulatory News

    ICH Expands MedDRA's Uptake Globally

    The International Council for Harmonization (ICH) on Monday touted the global expansion of its Medical Dictionary for Regulatory Activities (MedDRA) and provided updates on other activities related to MedDRA. According to ICH, MedDRA is now used by more than 5,000 subscribers in 103 countries. "This reflects the successful adoption of MedDRA as a worldwide standard in the protection of public health," ICH said following MedDRA's management board meeting in Montreal last...
  • Regulatory NewsRegulatory News

    ICH Working Group to Provide More Detailed Guidance

    The International Council on Harmonisation (ICH) on Monday outlined a proposal to extend the remit of the Points to Consider (PtC) Working Group to provide more detailed guidance, examples and “Questions and Answers” on topics of regulatory importance such as data quality, medication errors and product quality issues. According to a new concept paper endorsed by the ICH MedDRA (Medical Dictionary for Regulatory Activities) Management Board in November 2016, topics that ...
  • ICH Releases Updated MedDRA Guidance

    The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) released 2 April new guidance on using the Medical Dictionary for Regulatory Activities (MedDRA). The two released guidance documents - MedDRA Term Selection: Points to Consider Documents and MedDRA Data Retrieval and Presentation: Points to Consider Documents - provide best practice approaches for data entry (coding) and data retrieval/ana...