The effect of publicly stated economic strategies cannot be overstated. These strategies drive the direction of the global life-science ecosystem. Good companies utilize Quality Risk Management (QRM) practices to integrate them into company-specific strategies. Great companies transform them into the proverbial competitive advantage, ensuring the right drug, at the right time, to the right patient.
The publication of strategies for the U.S., EU, and China can give insight into what to expect from now into 2030. These strategies include:
- EU Strategy: “A strategy to position the EU as the world’s most attractive place for life sciences by 2030” (EUR-Lex – 52025DC0525 – EN – EUR-Lex)
- China Strategy: Recommendations of the Central Committee of the Communist Party of China for Formulating the 15th Five-Year Plan for National Economic and Social Development
- U.S. Strategy: Federal position stated in various documents such as:
- Strategic Plan | HHS.gov (planned update in 2026)
- Fact Sheet: President Donald J. Trump Announces Major Developments in Bringing Most-Favored-Nation Pricing to American Patients | The White House
- CMS Announces New Drug Payment Model to Strengthen Medicaid and Better Serve Vulnerable Americans | HHS.gov
A previous Lachman blog (New Risks Identified as ICH Q9(R1) Matures) outlines specific risks when supply-chain routes change as a result of policy and technology changes.
A quick comparison of these strategies can yield insightful intelligence on not only the direction of the global supply chain but also on how regulators will interact and perform their regional functions to ensure that the safety of patients is always protected. The most recent FDA Report on the State of Pharmaceutical Quality highlights the shift in location of manufacturing sites; this shift will probably continue given the tension in these strategies. A cursory review of these strategies can give insight into the future movement of typical product families.
Small Molecules and Generics
The EU strategy emphasizes the importance of generic medicines, which account for nearly 70% of dispensed drugs. However, fragmented procurement and over-reliance on low-cost sourcing have led to supply vulnerabilities. The proposed Critical Medicines Act aims to stabilize supply by incentivizing EU-based production and strategic procurement coordination.
In the U.S., generics are central to cost-containment efforts. The Most-Favored-Nation (MFN) pricing reform and Medicaid payment models benchmark prices against international standards, directly impacting small-molecule generics like insulin and GLP-1 agonists.
China, while less focused on generics in its 15th Five-Year Plan, is pushing for domestic innovation in small molecules to reduce reliance on foreign intellectual property. The plan supports upgrading traditional chemical industries and enhancing self-sufficiency in essential medicines.
Active Pharmaceutical Ingredients (APIs)
All three regions recognize the strategic importance of APIs. The EU aims to reduce dependency on non-EU sources by investing in local API production and diversifying suppliers. The Critical Medicines Alliance is tasked with identifying vulnerabilities and coordinating responses.
The U.S. strategy includes onshoring API manufacturing through the Essential Medicines Supply Chain Resilience Plan, which targets 50–100 critical drugs. The Equip-A-Pharma initiative further supports agile, AI-enabled API production.
China is focused on building secure, full-chain control of pharmaceutical supply, including APIs. The plan promotes regional manufacturing hubs and risk-resilient supply chains to ensure national security.
Bulk Biologics and Advanced Therapies
The EU sees its advantage in biologics and advanced therapies, with strong support for CAR-T cell therapies, gene therapies, and biotech innovation. This strategy promotes digital transformation and real-world data integration to accelerate development.
The U.S. supports biologics through federal R&D funding and streamlined FDA approvals. The Equip-A-Pharma program enables point-of-care biologics manufacturing, enhancing responsiveness and resilience.
China identifies biopharma—including mRNA platforms, gene therapy, and precision medicine—as strategic emerging industries. The plan supports domestic R&D, talent development, and integration of AI in drug discovery.
Cell and Gene Therapies
Both the EU and China prioritize cell and gene therapies as future growth areas. The EU’s strategy includes regulatory modernization to support these therapies, while China’s plan emphasizes domestic innovation and global competitiveness in this space.
The U.S. approach is more decentralized (hence the multiple references required to write this blog) but includes regulatory streamlining and public-private partnerships to support commercialization and manufacturing of advanced therapies.
The directions are set, now what are you doing to prepare? Lachman provide high-value services that can help you prepare proactively in such areas as facility readiness, data governance, quality culture, and pathways to licenses. Staying inspection-ready in turn ensures supply and ultimately protects patients.
