Overview
Numerous US pharmaceutical industry groups are urging the Food and Drug Administration (FDA) to expand the scope of the recently launched PreCheck Program. Initially focused on accelerating the establishment of new domestic manufacturing facilities, the industry is now advocating for the inclusion of existing factories and the integration of PreCheck with current regulatory initiatives. The main goal is to maximize the program’s impact to rapidly strengthen supply chain resilience and support the generic drug sector.
Introduction
The Challenge of Foreign Dependence
The United States’ reliance on foreign manufacturers for medicines and Active Pharmaceutical Ingredients (APIs) has been a growing concern, amplified by recent supply chain disruptions. In response, the FDA launched the PreCheck program in August 2025.
PreCheck aims to increase regulatory predictability and facilitate the construction of new domestic factories through a two-phase process: providing early regulatory feedback during the design, construction, and pre-production stages (Facility Readiness Phase), and streamlining the assessment and inspection during the application submission phase. However, the industry perceives untapped potential and is requesting a strategic expansion to achieve faster and more comprehensive results.
The Three Lines of Action Proposed by the Industry
In response to the FDA’s request for feedback on the program, the pharmaceutical industry articulated three main areas for improvement, which aim to quickly capitalize on the initiative:
- Expansion to Existing Manufacturing Facilities
This is the most emphatic point. Groups such as the Biotechnology Innovation Organization (BIO) and the Bulk Pharmaceuticals Task Force (BPTF) argue that restricting PreCheck only to new constructions limits the short-term impact.
The Request: Include existing manufacturing facilities undergoing modernization, capacity expansion, or those “reshoring” (bringing back) the production of critical APIs or essential medicines to the US.
The Justification: The inclusion of existing factories can significantly accelerate the availability of new production capacity in compliance with Good Manufacturing Practices (cGMP), addressing national security concerns more quickly. Modernizing an existing facility is often faster than building a new one.
- Integration with Current Regulatory Programs
The industry proposed that PreCheck should not operate in isolation, but rather in synergy with other FDA modernization initiatives.
The Request: Integrate PreCheck with programs such as the Advanced Manufacturing Technologies Designation and the Platform Technologies Designation.
The Justification: This linkage would provide greater regulatory visibility to new approaches and help “de-risk” the use of cutting-edge technologies, encouraging the adoption of advanced manufacturing methods, such as continuous production, which increase quality and efficiency.
- Strengthening the Generic Drug Industry
The generic sector is particularly vulnerable to foreign dependence (about 69% of generic drugs in the US have at least one foreign manufacturer). Strengthening this sector is considered crucial for resilience and medicine accessibility.
The Request: Implement additional government initiatives, such as the new ANDA Prioritization Pilot (ANDA stands for Abbreviated New Drug Application) for generic drugs fully manufactured and tested in the US.
The Justification: Incentives, such as faster regulatory review, reward investment in domestic R&D and manufacturing, ensuring access to high-quality and affordable medicines.
Key Takeaways for GRP and the Global Scenario
Although PreCheck is an FDA (US) initiative, its implications resonate globally, including in Brazil:
Focus on Quality: PreCheck reinforces the global trend of raising quality and compliance standards from the initial project phases (Quality by Design).
Supply Chain Resilience: The “reshoring” movement in the US may, in the long term, affect global export dynamics, requiring international manufacturers to adapt to a more competitive and regulated market regarding supply security.
Lesson for ANVISA: Initiatives like PreCheck and the Generic Prioritization Pilot offer models for other regulatory agencies, such as ANVISA, to create incentives that strengthen national production and accelerate access to essential medicines.
Conclusion
The FDA’s PreCheck Program is an important step toward increasing regulatory predictability and boosting domestic pharmaceutical manufacturing in the US. The industry’s proposals to expand the program to existing facilities and integrate it with other regulatory initiatives are strategic and aim to accelerate the benefits of safety and predictability in the supply chain.
For GRP, careful analysis of these global compliance and modernization trends is essential to maintain competitiveness and alignment with the highest international regulatory standards.
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References
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About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.