Washington (The Palestine Telegraph Newspaper) February 01, 2026
– The US Food and Drug Administration has launched a new PreCheck pilot
programme intended to strengthen domestic pharmaceutical manufacturing and
improve the resilience of the national drug supply chain. The initiative will
streamline regulatory interactions for new US-based drug production facilities
and aims to make it easier and faster for manufacturers to build and qualify
plants in the United States.
Applications for participation open on 1 February 2026, with
the FDA planning to select an initial cohort of facilities later this year
based on alignment with federal priorities, including production of critical
medicines for the US market. The programme forms part of a broader strategy,
backed by President Donald Trump, to reduce reliance on foreign drug manufacturing
and mitigate shortages of essential medicines.
The US Food and Drug Administration (FDA) said the PreCheck
pilot programme is designed to increase regulatory predictability and
streamline assessment of new domestic pharmaceutical manufacturing facilities.
The initiative follows recent policy directions from the White House aimed at encouraging
companies to locate drug production in the United States, including an
executive order instructing the agency to remove unnecessary regulatory hurdles
for domestic facilities.
PreCheck pilot aims to streamline US drug plant approvals
According to the FDA, the PreCheck programme will focus on
new pharmaceutical manufacturing sites that intend to supply the US market and
that can demonstrate strong alignment with national priorities, such as
producing critical medicines and advancing innovative manufacturing methods.
The agency will begin accepting facility applications on 1 February and will
continue to receive submissions until 1 March, after which it plans to select
an initial group of sites by 30 June.
PreCheck is structured as a two-phase process covering both
early facility development and the regulatory review of manufacturing
information within drug applications. In the first phase, known as the Facility
Readiness Phase, selected manufacturers will receive early technical advice
from FDA staff on elements such as facility design, construction plans and
pre-operational activities, supported by a facility-specific Drug Master File
to allow advance evaluation of site-related information.
In the second phase, the Application Submission Phase, the
programme will enable additional engagement through pre-submission meetings,
targeted inspections and expedited assessment of manufacturing data in
marketing applications.
FDA Commissioner Marty Makary said the PreCheck initiative
is one of several measures the agency is taking to support a robust domestic
drug supply and reduce dependence on overseas manufacturing. He described the
programme as a way to simplify assessment of US-based plants and to remove
duplicative or unnecessary regulatory requirements while maintaining standards
designed to ensure product quality.
Programme linked to Trump administration push for domestic production
The launch of the PreCheck pilot follows a May executive
order by President Donald Trump on “Regulatory Relief to Promote Domestic
Production of Critical Medicines”, which directed the FDA to streamline and
accelerate the development of domestic pharmaceutical manufacturing. The order
instructed the agency to improve inspection processes, eliminate redundant
requirements and provide clearer, earlier guidance to companies seeking to
build drug plants in the United States.
Reuters reported that the administration has also signalled
it may use tariffs on pharmaceutical imports, starting at relatively low levels
and potentially rising as high as 250 percent, as an additional tool to
encourage relocation of drug manufacturing to the US. The FDA initiative is
intended to complement these broader policy measures by directly targeting
regulatory processes that can affect investment decisions by drug makers.
In a separate statement, the FDA said PreCheck incorporates
feedback from manufacturers, healthcare providers and other stakeholders
gathered during a 2025 public meeting on onshoring pharmaceutical production.
The agency said participants highlighted the need for earlier and more
predictable engagement with regulators, particularly during facility design and
construction, to reduce uncertainty around future inspections and application
reviews.
Selection criteria and national priority focus for facilities
The FDA has stated that facilities selected for PreCheck
will be chosen based on “overall alignment with national priorities” across
several criteria. These criteria include the types of products to be
manufactured, the stage of facility development, the timeline for delivering
products to the US market and the degree of innovation in facility design or
manufacturing technology.
Additional priority will be given to plants that plan to
produce medicines regarded as critical for US patients, particularly those
where supply disruptions have previously contributed to shortages. The agency
has not published a detailed list of products covered by this designation in
its public announcements, but it has framed the initiative as part of a broader
strategy to reduce drug shortages and enhance public health protection by
strengthening supply chain resilience.
According to a January news release, the FDA expects to
start conducting PreCheck activities with the selected initial cohort of facilities
during 2026. These activities will include structured interactions between
agency staff and participating manufacturers over the course of facility
development, as well as coordination with subsequent inspections linked to
specific drug applications.
Regulatory support, facility engagement and expected benefits
The PreCheck programme is intended to provide participating
manufacturers with earlier and more frequent contact with the FDA than is
typical under standard processes. In practice, this will involve agency input
on facility layouts, equipment selection, quality systems design and other
technical aspects before a site begins commercial operations.
By allowing facility-specific information to be reviewed in
advance through a dedicated Drug Master File, the FDA aims to reduce the amount
of site-related assessment required once a company files a marketing
application for a particular drug. This approach is expected to shorten review
timelines for products manufactured at PreCheck facilities, though the agency
has not specified numerical targets for time reductions in its public
statements.
An FDA resource document on quality management maturity, published by the agency’s Center for Drug Evaluation and Research (CDER), notes that promoting advanced quality practices at manufacturing establishments is a key element of efforts to strengthen the pharmaceutical supply chain. The QMM programme, which aims to encourage manufacturers to adopt quality systems that go beyond current good manufacturing practice requirements, is being developed in parallel with initiatives such as PreCheck.
According to CDER, these
measures are intended to support more reliable production and to provide
regulators with greater insight into the state of quality at facilities that
supply the US market.
Broader strategy to tackle shortages and supply chain risks
The FDA has linked the PreCheck pilot to a broader policy
framework designed to address recurring shortages of medicines and
vulnerabilities exposed in the US pharmaceutical supply chain. This framework
includes plans to enhance domestic capacity, diversify sourcing, and encourage
investment in technologies that can improve the robustness and flexibility of
manufacturing.
In previous communications, the agency has also announced
separate pilot projects to accelerate review of certain domestically made
generic drugs as part of efforts to expand availability of lower-cost
treatments and to reduce dependence on imports. These pilots are intended to
complement facility-focused initiatives by targeting product-level regulatory
processes.
The FDA has said that data and experience gathered from the
PreCheck pilot will inform potential future expansion of the programme or
integration of its elements into standard regulatory practice. The agency plans
to monitor outcomes such as construction timelines, readiness for inspection,
and the incidence of post-approval manufacturing issues at participating
facilities.
Industry response and next steps for implementation
Industry stakeholders have previously raised concerns about
the impact of global disruptions on the availability of active pharmaceutical
ingredients and finished medicines in the US market, particularly when
manufacturing is heavily concentrated in a small number of foreign locations.
In public forums and consultation exercises referenced by the FDA, companies
have pointed to regulatory complexity and uncertainty as factors that can
affect decisions about where to build new plants.
The PreCheck programme offers manufacturers the opportunityto engage with the FDA at earlier stages than usual, but participation is
voluntary and restricted to new facilities that meet the selection criteria set
out by the agency. Establishments that are chosen will still be required to
comply with all applicable statutory and regulatory requirements, including
current good manufacturing practice standards and pre-approval inspections associated
with specific drug applications.
The FDA has indicated that information obtained through
PreCheck interactions may help streamline subsequent application reviews, but
it has emphasised that marketing approvals will continue to be based on
established safety, efficacy and quality standards. The agency has not
announced a fixed duration for the pilot but has stated that it will evaluate
programme performance before deciding whether to expand, modify or discontinue
the initiative.
Timeline and key milestones for PreCheck pilot
According to the FDA’s January announcement, the key dates
for the PreCheck pilot in 2026 are as follows: opening of applications on 1
February, closure of the application window on 1 March and selection of the
initial facility cohort by 30 June. PreCheck activities with the selected sites
are expected to begin later in 2026, with results and lessons learned to be
assessed on an ongoing basis.
Alongside the pilot, CDER continues to refine its approach
to quality management maturity assessments, including voluntary programmes that
evaluate management commitment to quality, business continuity, technical
excellence, advanced quality systems and employee engagement at drug
manufacturing sites.
The agency has said these initiatives collectively aim to support a more resilient pharmaceutical supply chain that can better withstand disruptions and ensure timely access to medicines for patients in the United States.