Useful Resources
Regulatory guidelines
Not an expert? Here's a summary for you: "Regulatory Pathways in Nanomedicine"
Regulatory requirements in clinical development are crucial, as they ensure that innovative therapies are evaluated thoroughly for safety and effectiveness before they are authorized by Regulatory agencies to reach patients. Nanomedicines, like all medical products, must adhere to strict standards for safety, efficacy, and pharmaceutical quality. Their complex nature featuring unique combinations of nano-scale engineering and medical application, is distinctly more elaborate than the ones for traditional small molecule drugs, which poses significant analytical challenges. METRINO will help by providing specific measurement methods in line with regulatory guidelines and reflection papers to aid in the quality assessment of these innovative nanomedicine treatments, ensuring they meet the high standards required for clinical application and patient care.
Nanotherapeutics are subject to rigorous legislative and regulatory standards, similar to other classes of healthcare products, which are medicinal products and medical devices. When applying for clinical application, these innovative therapies must demonstrate comprehensive data proving their quality, safety, and efficacy. Nanomedicines are held to the same stringent criteria as all drug products. Yet, their hybrid nature, combining nano-scale engineering with biomedical science, presents unique challenges in quality assessment. This complexity is heightened when compared to the relatively simpler structure of small molecular drugs or biologicals like antibodies. To assist the community in navigating these intricacies, regulatory agencies offer specialized guidelines and reflection papers, ensuring a thorough evaluation of nanomedicine formulations for both quality and safety.
Where to access regulatory guidance and reflection papers?
Regulatory documents specifically addressing nanotechnology-enabled health products that may help you are:
All products including health care products
Consumer products including medical products
Electronics, cosmetics, textiles, health products
Products containing nano-silver
Wound dressing with silver nanoparticles
Medicinal products
Nanotechnology-based medicinal products
Albumin-bound paclitaxel NP, Glatiramer acetate
Liposomal products
Liposomal doxorubicin, Liposomal daunorubicin, Pegylated liposomal irinotecan, Liposomal Amphotericin B, Liposomal Hepatitis A vaccine
- EMA/CHMP. Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product.
- FDA/CDER. Guidance for Industry. Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation (2018)
- FDA- Draft Guidance on Doxorubicin Hydrochloride
- MHLW. Guideline for the development of liposome drug products
- EMA Liposomal amphotericin B product-specific bioequivalence guidance
Block copolymer micelle products
Peginterferon alpha-2a, Pegaspargase Sevelamer
Iron based nano-colloidal products
Ferumoxytol, Ferric carboxymaltose
Nucleic acid-loaded nanotechnology-based drug products
siRNA-loaded and mRNA-loaded lipid and polymeric NPs, ONPATTRO (patisiran),
COVID-19 vaccine - Spikevax, COVID-19 vaccine Comirnaty
- MHLW. Reflection paper on nucleic acids (siRNA)-loaded nanotechnology based drug products (2016)
- WHO guideline on Messenger RNA vaccines- Evaluation of the quality, safety and efficacy of messenger RNA vaccines for the prevention of infectious diseases: regulatory considerations
- USP Draft Analytical Procedures for mRNA Vaccine Quality
Coated nanomedicine products
PEGylated liposomes, products with targeting ligand on the surface
Medical devices
Medical devices containing nanomaterial
Nanostructured hydroxyapatite, Nano-ceramic dental composite, tumour tracers
- ISO/TR 10993-22:2017
- European Commission: New regulations on medical devices
- Medical Devices Regulation (EU) 2017/745
- In-Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
- Scientific opinions concerning medical devices: SCENIHR Final Opinion on ‘Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices’
- European Trade Association for Medical Technology Industries (MedTech Europe)