GxPラインの両側における製薬調達。

情報源

1. [1] The White House (April 2, 2026), Proclamation 11020, Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients into the United States100% on patented pharmaceuticals and their ingredients; 15% for the EU, Japan, Korea and Switzerland; 20% with an approved onshoring plan until April 2, 2030; zero with a pricing agreement until January 20, 2029; generics and biosimilars excluded; effective July 31 and September 29, 2026
2. [2] Federal Register (April 9, 2026), 91 FR 18183, FR Doc. 2026-06956Proclamation 11020
3. [3] The White House, Proclamation 11020 Annex Ipatented pharmaceutical articles include their active pharmaceutical ingredients and key starting materials
4. [4] US Department of Commerce, Bureau of Industry and Security (August 4, 2026), 91 FR 49406zero rate for UK-origin patented pharmaceuticals entered on or after July 31, 2026
5. [5] US Department of Commerce, Bureau of Industry and Security (September 23, 2026), 91 FR 60360excipients are not pharmaceutical articles; no section 232 duty on imports solely for clinical trials or research, from September 29, 2026
6. [6] US Department of Commerce, Bureau of Industry and Security (May 13, 2026), 91 FR 26989onshoring plan applications may tie their timelines to expected FDA approvals
7. [7] US Food and Drug Administration, Changes to an Approved NDA or ANDA, Revision 1 (April 2004, still final)a move to a site without a satisfactory CGMP inspection for the type of operation is a prior approval supplement; otherwise most site moves are 30-day supplements; a satisfactory inspection is NAI or VAI
8. [8] US Food and Drug Administration, CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports (March 2014)a new supplier of an inactive ingredient named in the application, specification unchanged
9. [9] US Food and Drug Administration, Postapproval Changes to Drug Substances (draft, September 2018, not for implementation)a switch from one drug substance manufacturer to another proposed as a change in source, a multiple change
10. [10] 21 CFR 314.70supplements and other changes to an approved NDA; product made under a 30-day supplement may be distributed 30 days after FDA receives it
11. [11] US Food and Drug Administration, PDUFA VII Performance Goals and Procedures, FY2023-202790% of prior approval manufacturing supplements acted on within 4 months, other manufacturing supplements within 6
12. [12] US Food and Drug Administration, GDUFA III Performance Goals and Program Enhancements, FY2023-2027standard ANDA prior approval supplements within 6 months, or 10 with a pre-approval inspection
13. [13] US Food and Drug Administration, Report on the State of Pharmaceutical Quality, FY202528% of FY2024-25 submissions needing a facility assessment received a complete response letter, 43% of them over a facility
14. [14] US Food and Drug Administration, Data Dashboard, compliance dashboardsfinal NAI, VAI and OAI inspection classifications
15. [15] US Food and Drug Administration, Data Dashboard, inspectionsstate and pre-approval inspections are not included
16. [16] 21 CFR 211.84components, containers and closures withheld from use until released by the quality control unit
17. [17] 21 CFR 211.22the quality control unit approves or rejects components and products made under contract
18. [18] 21 CFR 200.10contract facilities as an extension of the manufacturer's own facility
19. [19] 21 CFR 211.56sanitation procedures, including pest control, apply to contractors
20. [20] 21 CFR 211.34consultants
21. [21] 21 CFR 211.68automatic, mechanical and electronic equipment, including computer systems
22. [22] 21 CFR 211.160laboratory controls, including the calibration of instruments
23. [23] 21 CFR 58.1good laboratory practice for nonclinical laboratory studies
24. [24] US Food and Drug Administration, Contract Manufacturing Arrangements for Drugs: Quality Agreements (November 2016)the owner's quality unit remains responsible; changes to components and their suppliers; quality agreements kept separate from commercial terms
25. [25] ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredientssuppliers approved by the quality unit; contract manufacturers make no change without the contract giver's approval
26. [26] ICH Q10, Pharmaceutical Quality System, section 2.7management of outsourced activities and purchased materials
27. [27] ICH E6(R3), Good Clinical Practice (January 6, 2025)the sponsor selects and oversees service providers and keeps responsibility
28. [28] US Food and Drug Administration, E6(R3) Good Clinical Practice (September 2025)ICH E6(R3) issued as FDA final guidance for industry
29. [29] Federal Register (February 2, 2024), 89 FR 7496Quality Management System Regulation, effective February 2, 2026, incorporating ISO 13485:2016; ongoing, risk-based supplier assessment
30. [30] US Food and Drug Administration, Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017)supplier-driven material changes analyzed even within specification
31. [31] Public Law 119-60, National Defense Authorization Act for Fiscal Year 2026, section 851 (December 18, 2025)the OMB list of biotechnology companies of concern within one year; five years of protection for earlier contracts
32. [32] American Society of Health-System Pharmacists, drug shortage statistics (January 2001 to June 2026)48% of 2026's new shortages involve sole-source products
33. [33] Abeona Therapeutics, Form 10-K for 2024 (March 2025)FDA approval is required before any new manufacturer can be used for commercial supply
34. [34] US Food and Drug Administration, Sterilization for Medical Devicesabout half of US sterile medical devices are sterilized with ethylene oxide
35. [35] US Environmental Protection Agency (April 5, 2024), 89 FR 24090ethylene oxide emissions standards for commercial sterilizers, compliance from April 6, 2026
36. [36] BioPhorum (August 2022)supply change notifications surged after the pandemic began