Regulatory Roundup: EMA Reviews Drug Marketing Authorization Applications, And More.
ePT--the Electronic Newsletter of Pharmaceutical Technology
EMA Reviews Drug Marketing Authorization Applications, And More.
Last week, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) met to review and discuss drug marketing authorization applications. Several decisions were made (see full press release) including the committee’s recommendation to harmonize globally the prescribing information for Lipitor (atorvastatin).
Next week, in Bethesda, Maryland, ISPE and PDA will cohost a workshop on the implementation of pharmaceutical development, risk management, and quality systems as part of the ICH quality-trio workshop series. The workshop will feature members of the ICH Quality Implementation Working Group, including representatives from FDA and EMA, and include breakout sessions on design space, control strategy, quality system, and risk management. Industry is encouraged to attend.
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.
