Advanced tissue products—including engineered tissues, 3D bioprinted constructs, and decellularised matrices—revolutionise regenerative medicine. However, regulatory compliance for these products is complex, with requirements varying by region and product classification.
CERES advanced tissue product regulatory compliance guides companies through the intricate approval pathways for human cell and tissue products (HCT/Ps), combination products, and advanced tissue-engineered medical products (TEMPs). With expertise in FDA (U.S.), EMA (Europe), PMDA (Japan), and other global regulations, CERES ensures seamless compliance and accelerated market access.
Why Advanced Tissue Products Face Unique Regulatory Challenges
Unlike traditional biologics or medical devices, advanced tissue products often fall under multiple regulatory categories, leading to complex compliance requirements:
- Classification Variability – Products may be regulated as HCT/Ps (361 vs. 351 in the U.S.), medical devices (Class III), or combination products.
- Strict Donor Eligibility & Processing Controls – Compliance with 21 CFR 1271 (U.S.) and EUTCD (Europe) is mandatory.
- Complex Manufacturing & CMC Requirements – Sterility, viability, and biomechanical properties must be rigorously validated.
- Preclinical & Clinical Evidence Demands – Agencies require robust biocompatibility, engraftment, and functional data.
- Post-Market Surveillance – Long-term monitoring is critical for safety and efficacy.
How CERES Supports Advanced Tissue Product Compliance
CERES provides end-to-end regulatory strategy and compliance support, including:
1. Regulatory Classification & Pathway Strategy
- Determining whether a product is a HCT/P, biologic, medical device, or combination product.
- Navigating FDA’s 21 CFR 1271 (HCT/Ps) vs. PHS 351 (biologics) distinctions.
- EMA’s Advanced Therapy Medicinal Product (ATMP) classification and centralized procedure.
2. CMC & Quality Systems Compliance
- Tissue processing, sterilization, and preservation controls.
- GMP compliance for human cells, tissues, and cellular/tissue-based products (HCT/Ps).
- Stability testing, potency assays, and comparability protocols.
3. Preclinical & Clinical Trial Support
- Designing biocompatibility, mechanical integrity, and animal model studies.
- IND/IDE submissions for tissue-engineered products.
- Expedited pathway navigation (RMAT, Breakthrough Device, PRIME).
4. Global Submissions & Market Access
- FDA (CBER/CDRH), EMA (CAT), PMDA, Health Canada, and NMPA (China) filings.
- Harmonizing U.S. (FDA) and EU (MDR/IVDR) requirements.
5. Post-Market Compliance & Lifecycle Management
- Adverse event reporting and post-approval studies (PAS).
- Labeling updates, PMA supplements, and variations.
Why Choose CERES for Advanced Tissue Regulatory Compliance?
✔ Deep Expertise in Tissue Engineering & Regenerative Medicine – Experience with skin grafts, cartilage implants, cardiac patches, and more.
✔ Proven Success in Complex Classifications – Track record with combination products, ATMPs, and HCT/Ps.
✔ Strategic Agency Interactions – Strong relationships with FDA, EMA, and global regulators.
✔ Risk-Based Compliance Approach – Minimizes delays and maximises approval chances.
Conclusion
Navigating the regulatory landscape for advanced tissue products requires specialized knowledge of tissue engineering, biologics, and medical device regulations. CERES advanced tissue product regulatory compliance provides the strategic guidance needed to achieve compliance, secure approvals, and bring groundbreaking therapies to patients.
Contact CERES today to streamline your advanced tissue product’s regulatory pathway.