The reliability of clinical tests used to win approval for some medicines -- particularly generic copies of original drugs -- could be in doubt due to an apparent software glitch that may mean data was calculated incorrectly.


An official at the London-based European Medicines Agency (EMA) told Reuters that the issue, involving Thermo Fisher Scientific's Kinetica package, would be discussed by European regulators at a meeting next week.


Thermo Fisher -- a U.S.-based maker of laboratory equipment and life science research tools with an annual turnover of $17 billion -- said it was looking into the matter, which was first raised by independent experts in a scientific paper.


The problem could mean some medicines have been approved on incorrect data. Others may have been rejected, or never submitted, even though they might have been good enough for use.


The scale of the potential problem is unclear, but may extend to medicines submitted for approval in Europe, the United States and beyond.