Articles relevant to the safety of medicinal products are usually published in well-recognised scientific and medical journals; however, new and important information may be first presented at international symposia or in local journals. Although the most well-known databases (e.g. Medline) cover the majority of scientific and medical journals, the most relevant publications may be collated elsewhere in very specialised medical fields for certain types of product (e.g. herbal medicinal products), or where safety concerns are subject to non-clinical research. The marketing authorisation holder should establish the most relevant source of published literature for each product.

Medline, Embase and Excerpta Medica are often used for the purpose of identifying ICSRs. These databases have broad medical subject coverage. Other recognised appropriate systems may be used. The database providers can advise on the sources of records, the currency of the data, and the nature of database inclusions. It is best practice to have selected one or more databases appropriate to a specific product. For example, in risk-benefit assessment, safety issues arising during non-clinical safety studies may necessitate regular review of a database that has a less clinical focus and includes more laboratory-based publications.

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.

Guidance in VI.C.2.2.3. should be followed for the searches of databases with broad medical coverage by the Agency in accordance with Article 27 of Regulation (EC) No 726/2004 and the ICSRs submission obligations of marketing authorisation holders in accordance with Article 107(3) of Directive 2001/83/EC.