Corrected October 20, 2026. An earlier version of this article, first published June 11, 2026 and based on a trade-press report, said FDA finalized new process validation guidance in 2026, that a revised EU GMP Annex 2 now covers synthetic peptides, and that ICH Q3D transition provisions expire in 2026. None of these is correct, and we have rewritten the article. See “What did not change” below.
EMA Guideline on Synthetic Peptides (June 1, 2026)
The EMA's first guideline on the development and manufacture of synthetic peptides was adopted in December 2025 and took effect on June 1, 2026. It sets expectations for the manufacturing process, characterisation, specifications and analytical control of synthetic peptides in EU marketing applications. Read our summary of the guideline.
BIOSECURE Act (December 18, 2025)
Enacted in the FY2026 NDAA, it restricts federal contractors from using biotechnology equipment or services from designated “biotechnology companies of concern.” The list of designated companies is due by December 2026. See what the BIOSECURE Act does.
FDA GLP-1 Green List, Import Alert 66-80 (September 2025)
GLP-1 API shipments such as semaglutide and tirzepatide can now be detained at the US border unless the manufacturer is on the FDA's green list. This applies on top of Import Alert 66-40, under which the FDA added peptide API makers during 2026. See how Import Alert 66-40 works.
What Did Not Change
- FDA process validation: the governing guidance is still “Process Validation: General Principles and Practices” from January 2011, which already includes continued process verification as Stage 3.
- EU GMP Annex 2: it covers biological medicinal products. We found no 2026 revision extending it to synthetic peptides. The EMA synthetic peptide guideline above is the relevant document.
- ICH Q3D elemental impurities: existing products in the EU had to comply from December 2017, and USP <232> applied from January 2018. There is no 2026 deadline.
References
- EMA Guideline on the Development and Manufacture of Synthetic Peptides
- Akin Gump — BIOSECURE Act Becomes Law
- Blank Rome — FDA Launches Green List to Combat Illegal GLP-1 Imports
- FDA — Process Validation: General Principles and Practices (2011)
- PharmTech — EMA Sets Elemental Impurities Implementation Dates