FDA launches PreCheck pilot programme for US pharma manufacturers

The US Food and Drug Administration (FDA) has opened its PreCheck pilot programme for applications as part of efforts to encourage pharma companies to build new manufacturing facilities.

The initiative aims to provide greater predictability by increasing regulator-pharma communication during the construction of new manufacturing sites and streamlining facility assessments prior to specific product applications.

An initial cohort of new pharmaceutical manufacturing facilities will be selected and begin conducting PreCheck activities this year.

Selection criteria include what products are planned for manufacture, phase of facility development, timeline to producing pharmaceutical products for the US market, and innovation in facility development.

Facilities producing critical medications for distribution in the US will be granted additional priority consideration by the FDA.

The PreCheck programme consists of two phases, with manufacturers benefitting from early technical advice before a facility becomes operational, in the Phase 1 ‘Facility Readiness Phase’.

Specifically, participating pharmaceutical companies can access pre-operational reviews and use of a facility-specific Drug Master File to facilitate efficient evaluation of facility-specific elements prior to, and in support of, the submission of a drug application.

The Phase 2 ‘Application Submission Phase’ involves pre-submission meetings and inspections to address any issues and accelerate assessments of manufacturing information in a drug application.

FDA created the programme following US President Trump’s executive order to review domestic pharma manufacturing and then “eliminate unnecessary regulatory requirements while maximising review timeliness and predictability”.

FDA Commissioner Dr Marty Makary said: “The PreCheck programme is one of several powerful incentives we are providing to make the US pharmaceutical manufacturing sector more resilient and competitive.”

Those incentives have been paying off over the last year, with increasing numbers of pharma companies announcing investments in US manufacturing facilities. Most recently, Lilly finalised plans for the final location of its four new US sites.