The New EMA Protect ADR Database
By Bart Cobert
On February 18, 2013 the EMA released a new Adverse Drug Reaction (ADR) database.
It is called the Protect Database and was developed by the EMA and some partners. It consists of all ADRs listed in section 4.8 (Undesirable Effects) of the Summary of Product Characteristics (SPC) for all centrally approved products. The database was updated as of 30 June 2012 based on the SPCs found at the European Commission’s website. It will be routinely updated at least once a year as new or amended SPCs are produced. Additional updates will be done to correct errors.
It is based on MedDRA PTs though LLTs may also be used if further precision is required. As not all the terms in the SPCs are in MedDRA so some mapping was done using “fuzzy text matching” and expert review of the mapping.
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