The European agency presents guidelines for conducting post-authorization efficacy studies.
The European Medicines Agency (EMA) has released a draft guideline on how companies should design post-authorization efficacy studies (PAES), which help the European Union to make regulatory decisions. The guideline also describes regulatory aspects for PAES fulfillment. PAES are either required by regulators or conducted voluntarily by drug companies. The guideline applies to both imposed and voluntary PAES and was developed in collaboration with EU Member States.
According to an EMA press release, PAES collect data on the benefits for a particular drug indication after market authorization. These data can include information on how the drug is used in everyday medical practice, how it is used in specific populations, how it relates to the use of other drugs, how it performs over time, and the drug’s mechanism of action. Data results may contribute to changes in labeling or may result in better use of the product.
Comments on the guideline are being accepted by EMA until Jan. 31, 2016.
Source: EMA
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A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
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