INOPP Forum

Please or Register to create posts and topics.

Local Literature Monitoring

Marketing Authorization Holders need to continue to monitor all other medical literature not covered by the literature reference databases. This includes scientific and medical publications in local journals in countries where medicinal products have a marketing authorisation. For very specialised medical fields, for certain types of medicinal products or where safety concerns are subject to non-clinical research, marketing authorisation holders should establish the most relevant source of published literature for each product.

Relevant published abstracts from meetings and draft manuscripts should be reviewed for valid ICSRs and for inclusion in periodic safety update reports. Although it is not a requirement for marketing authorisation holders to attend all such meetings, if there are company personnel at such a meeting, or it is sponsored by a marketing authorisation holder, it is expected that articles of relevance would be available to the marketing authorisation holder's pharmacovigilance system. In addition, literature that is produced or sponsored by a marketing authorisation holder should be reviewed, so that any valid  ICSRs can be submitted as required in advance of publication. If ICSRs are brought to the attention of a marketing authorisation holder from this source, they should be processed in the same way as ICSRs found on searching a database or reviewing a journal. Abstracts from major scientific meetings are indexed and available in some databases, but posters and communications are rarely available from this source.

The Marketing Authorization holder may consider the following options for ensuring compliance with local literature monitoring:

  1. Outsource local literature monitoring
  2. Local literature monitoring by the local company affiliates (one country)
  3. Local literature monitoring by the regional company affiliates (multiple countries in a region)
  4. Local literature monitoring by the distributors/business partners

The translation is one of the important aspects of the local literature monitoring, and the MAH needs to ensure that there are SOPs and contracts that clearly specify the responsibilities.