US FDA Says Data Integrity Remains Challenging For API Manufacturers
Data integrity issues were raised in many warning letters to active pharmaceutical ingredient manufacturers over the past four years.
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The US FDA always encourages sponsors to ensure their suppliers and contractors are following the law, but agency inspectors may have been the only ones who could have discovered the data integrity problems that forced the downgrading of more than 100 generic drug applications.
Despite the emergence of the coronavirus pandemic at the end of the period, Japan’s regulatory authorities maintained an annual pace of new drug approvals on a par with the previous year, with expedited programs helping several drugs to market.
The good news: 75% of never-before-inspected firms complied with US drug GMP requirements. The bad news: 25% did not.