In June 2025, the EMA revised its GMP guidelines, emphasizing stricter controls on biological products, including collagen-based therapies. This revision aims to enhance product safety and efficacy standards across member states.
In September 2025, the MHRA updated its post-Brexit regulatory framework, introducing new requirements for the importation of medicinal products, including collagen-based items, into the UK. These changes necessitate that Indian exporters adapt to the updated compliance measures to maintain market access.
In December 2025, the FDA issued a draft guidance document outlining the regulatory considerations for collagen-based medical devices, providing clarity on the approval process and quality standards expected for these products.
In February 2026, the WHO published a report highlighting the importance of quality assurance in the manufacturing of biological products, including collagen, urging manufacturers to adhere to international standards to ensure product safety and efficacy.
In March 2026, the CDSCO announced a streamlined process for the approval of biological products, including collagen-based therapies, aiming to expedite market entry while maintaining stringent safety and efficacy standards.
