157 - Under what conditions / what is the criteria in which a pharmaceutical company is required to report an adverse event in the social media sphere?

  • Please refer to the Health Canada policy document "Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products". The following excerpt applies specifically to events described on internet sites (including social media sites): MAHs [Market Authorization Holders] should regularly screen Web sites under their management or responsibility for potential AR [Adverse reaction] case reports. MAHs are not expected to screen external websites for AR information. However, if a MAH becomes aware of an AR on a website that it does not manage, the MAH should review the case and determine whether it should be reported. MAHs should consider utilising their websites to facilitate AR data collection, e.g., by providing AR forms for reporting or by providing appropriate contact details for direct communication. Cases from the Internet should be handled as unsolicited reports. For the determination of reportability, the same minimum criteria (i.e., identifiable reporter, identifiable patient, suspect product and AR) should be applied as for cases provided via other ways. If the minimum reporting criteria are met and the report is considered relevant by a qualified health care professional from the MAH, the case is considered "reportable" and must be forwarded to the MHPD in accordance with the Regulations The entire document can be found here.