145-9 Comment: Knowing that the database to be used is not Search Criteria: defined in this guidance, we recommend to specify that search Process clarity constructions should be revised and updated if needed, each time a thesaurus update is released. Search constructions are routinely Proposed changes: updated and maintained necessary to improve search precision and to align with any updates to the thesaurus used for indexing as well as to the substance groups as referred to in chapter 2.1. . Updates are announced in due time by the Agency. 158-161 EFPIA Comment: What methods will the EMA provider use for Translation: translation of articles? Are they validated? Where an article is Process clarity in a foreign language, will the agency translate into English and make text available to MAH? 166-167 EFPIA Comment: It is unclear what would be included in the search Published Lists: results that are published daily. By way of sample explain how Process clarity this will differ from the published list of ICSRs entered into Eudravigilance as per lines 238-246. Proposed change: Suggest rewording results based “Search on the execution of scripts are made publicly accessible on a daily basis and will include the above referenced data to allow the MAHs to identify if any ICSRs for their products have been identified from the search”. 166-167 EFPIA Comment: The outputs are provided in a tabular, Access: format on the EudraVigilance restricted website. Who Process clarity for access to the restricted has access to this website to review these uploads on a daily website. basis, noting that many MAHs have Business arrangements
145-9 Comment: Knowing that the database to be used is not defined in this guidance, we recommend to specify that search constructions should be revised and updated if needed, each time a thesaurus update is released. Proposed changes: Search constructions are routinely updated and maintained necessary to improve search precision and to align with any updates to the thesaurus used for indexing as well as to the substance groups as referred to in chapter 2.1. . Updates are announced in due time by the Agency. Search Criteria: Process clarity 158-161 EFPIA Comment: What methods will the EMA provider use for translation of articles? Are they validated? Where an article is in a foreign language, will the agency translate into English and make text available to MAH? Translation: Process clarity 166-167 EFPIA Comment: It is unclear what would be included in the search results that are published daily. By way of sample explain how this will differ from the published list of ICSRs entered into Eudravigilance as per lines 238-246. Proposed change: Suggest rewording “Search results based on the execution of scripts are made publicly accessible on a daily basis and will include the above referenced data to allow the MAHs to identify if any ICSRs for their products have been identified from the search”. Published Lists: Process clarity 166-167 EFPIA Comment: The outputs are provided in a tabular, format on the EudraVigilance restricted website. Who has access to this website to review these uploads on a daily basis, noting that many MAHs have Business arrangements Access: Process clarity for access to the restricted website.
efpia_comments_draft_guide_medical_literature-eudravigilance_database_66965.docx