FDA unveils PreCheck programme to enhance US domestic pharma supply chain
The US Food and Drug Administration (FDA) has unveiled a new programme aimed at boosting the country’s domestic pharmaceutical supply chain. The new initiative, FDA PreCheck, was developed in response to President Donald Trump’s executive order to accelerate the review of domestic pharmaceutical manufacturing and remove unnecessary regulatory requirements in the US.
Over half of pharmaceuticals distributed in the US are manufactured overseas, according to the FDA, highlighting the country’s dependence on foreign manufacturing. This extends to the production of active pharmaceutical ingredients (APIs), with only 11% of API manufacturers supplying FDA-approved products based in the US.
Featuring a two-phase approach, the PreCheck programme will seek to improve regulatory predictability and facilitate the construction of manufacturing sites.
The first ‘facility readiness phase’ will offer manufacturers more regulator communication with the FDA at key development stages such as facility design and pre-production. It will also encourage companies to provide facility-specific information through a type five drug master file, which can be included by reference into a drug application as appropriate.
The second ‘application submission phase’ will focus on streamlining the development of the chemistry, manufacturing and controls section of the application by providing pre-application meetings and early feedback.
FDA commissioner, Marty Makary, said: “Our gradual over-reliance on foreign drug manufacturing has created national security risks. The FDA PreCheck initiative is one of many steps FDA is taking that can help reverse America’s reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong and domestic drug supply.”
PreCheck is the latest in a series of initiatives recently introduced by the FDA. In June, the regulator unveiled its National Priority Voucher programme to reduce the review time for certain drug applications from around ten to 12 months to just one to two months.
The programme for companies “supporting US national interests” will convene experts from FDA offices for a team-based review, instead of using the standard system of a drug application being sent to multiple FDA offices.
The FDA also announced in May that all its centres would operate on a common generative artificial intelligence (AI) system by 30 June this year.
