Advanced therapies - guidance from regulators

Signposting to guidance from regulators
Body	Description of Resource/tool	Link
	Medicines and Healthcare products Regulatory Agency Guidance on licensing biosimilars, ATMPs and PMFs (latest update from May 2021)	https://www.gov.uk/guidance/guidance-on-licensing-biosimilars-atmps-and-pmfs#guidance-for-great-britain-marketing-authorisation-applications-for-advanced-therapy-medicinal-products-atmps
	Medicines and Healthcare products Regulatory Agency Advanced therapy medicinal products: regulation and licensing	https://www.gov.uk/guidance/advanced-therapy-medicinal-products-regulation-and-licensing
	European Medicine Agencies Scientific recommendations on classification of advanced therapy medicinal products	https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/advanced-therapies/advanced-therapy-classification/scientific-recommendations-classification-advanced-therapy-medicinal-products
	US Foof & Drug Administration Oversight of clinical studies, proactive scientific and regulatory advice to medical researchers and manufacturers of advanced therapeutics	https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products
	NICE-MHRA Scientific Advice For developers of medicinal products and other similarly regulated technologies. Allows joint regulatory advice from the Medicines and Healthcare products Regulatory Agency (MHRA) and NICE Scientific Advice	https://www.nice.org.uk/about/what-we-do/life-sciences/scientific-advice/nice-mhra-scientific-advice
	Advanced Therapies Treatment Centres Advanced Therapies NHS Readiness Toolkit	https://www.theattcnetwork.co.uk/advanced-therapies-nhs-readiness-toolkit