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
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