Deluge of GMP clearance overwhelms regulatory watchdog

Pharma News: In a race against time, the Therapeutic Goods Administration (TGA) is grappling with an unprecedented flood of applications for good manufacturing practice (GMP) clearance extensions. The TGA, responsible for ensuring the safety and quality of medicines and pharmaceutical ingredients, is struggling to keep up with the overwhelming volume of requests, causing significant delays and concerns for sponsors.

GMP clearance is granted to sponsors who provide satisfactory evidence of compliance with the established manufacturing practices for medicines and active pharmaceutical ingredients produced overseas.

The current predicament stems from a staggering increase in the number of extension applications, resulting in extensive processing delays. The TGA has warned that it may not be able to complete the evaluation of some extension requests before existing clearances expire, raising serious implications for sponsors.

Should a clearance expire before an extension is granted, the TGA has advised sponsors not to reach out unless it affects a regulatory submission to list, register, or modify a product on the Australian Register of Therapeutic Goods (ARTG). In such cases, sponsors can directly contact the TGA’s dedicated GMP clearance team.

To alleviate the burden on its operations and mitigate potential disruptions, the TGA has urged sponsors to file extension applications at least one month prior to their GMP clearances expiring. However, some sponsors have failed to comply with this recommendation, exacerbating the challenges faced by the regulatory agency.

The TGA attributes the current difficulties to various factors that have contributed to the surge in application volumes during the pandemic. Travel restrictions have impeded the return of international GMP inspections to pre-pandemic levels, resulting in delays. Additionally, the implementation of new processes during the pandemic has extended processing times for GMP clearance assessments. Last year, the TGA reported a staggering 36% increase in application volumes since the 2018-19 financial year, highlighting the magnitude of the issue.

Furthermore, the TGA has identified several other factors that contribute to processing delays. Extensions related to medicine shortages and COVID-19 vaccines and treatments have added to the workload. Moreover, extension applications submitted less than one month before expiry have further strained the system. Additionally, an upswing in “reinstatement” requests, made when sponsors allow their GMP clearances to lapse for more than 30 days, has significantly impeded processing times. The TGA previously tackled a backlog of 5,600 applications between 2015 and 2019, when processing times ballooned to a staggering nine weeks at one point.

As the TGA races against the clock to address this mounting delays, stakeholders and sponsors are closely monitoring the situation.

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