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P202: Comparison of Product Information Provided by the EMA and the FDA for the Drugs Acting on the Central Nervous System

Poster Presenter

      Prachi Arora

      • Vice President and Head Medical Safety
      • APCER Life Sciences
        United States


To compare the product information published by the EMA and the FDA in the form of the European Union (EU) summary of product characteristics (SmPC) and the US prescribing information (USPI), respectively, and to identify the information being conveyed to the healthcare professionals (HCPs).


Descriptive analysis of the product information published by the EMA and the FDA was done to assess the difference between the EU SmPC and the USPI. Ten out of 138 drugs acting on the CNS were chosen due to availability of SmPCs and Physician’s Labeling Rule Format USPI, for consistent comparison


Ten drugs, which fulfilled the criteria for inclusion in this study, were as follows: pregabalin, levetiracetam, levodopa/carbidopa, pramipexole, duloxetine, loxapine, aripiprazole, olanzapine, rivastigmine and memantine. For each drug, the following characteristics were extracted and analysed from the product information: indication, dosage, clinical trials, primary endpoint, adverse drug reaction and black box warning. The presentation or order of information was also analysed. Overall, 82.9% of prominent distinctions were identified between the two product label formats. For indication, the most prominent distinctions were identified in the number of approved indications, where 60% drugs vary in this parameter; for dosage, the most prominent distinction was in the dosing regimen, with a prominent distinction identified in 60% of the drugs; and for clinical trials, the most prominent distinction was in the number of trials described and the different presentation of overall trial data, with a prominent distinction identified in 70% of the drugs. The choice of primary endpoints and the level of detail provided about the endpoints were also prominently different for 90% of the drugs. For adverse drug reactions, all drugs (100%) were different for this section because the USPI described safety data as incidence of patients reporting reaction in trials for approved indications; whereas the EU SmPC described safety data in order of frequency from very common to very rare. Similarly, for black box warnings, all drugs (100%) were different because of the different presentation for severe warnings. While the EU SmPC contained the same severe warnings, it did not highlight the information as prominently as did the boxed warning in the USPI. For order of information, the details regarding all drugs (100%) were prominently different.


Prominent distinctions (100%) between the USPI and the EU SmPC were identified in the following sections: adverse drug reactions, black box warning and order of information. The USPI presented the incidence of patients experiencing adverse reactions in trials numerically, in a percentage format, whereas the SmPC presented the information more generally by frequency (very common to very rare). The Physician’s Labeling Rule Format in the USPI also presented order of information differently by providing highlights of prescribing information, unlike the SmPC. The USPI prominently displayed severe warnings as black box warnings, whereas the SmPC made no distinction between severe warnings and other warnings. Publicly available drug product documents have the potential to be valuable and vital sources of safety information, but data included were found to be prominently different between the regions of the US and the EU. The reason for the differences between the USPI and the EU SmPC could be the different regulatory requirements for both authorities (FDA and EMA). The prominent distinctions identified in the product labels between the US and the EU may influence how HCPs interpret product information in different regions. These differences may also impact the HCPs of other deprived countries who rely on the USPI and/or the SmPC for product information. Considering global drug safety, all the stakeholders, including the regulators, need to work together to harmonise these product labels.