Body |
Description of Resource/tool |
Link |
|---|---|---|
 |
Medicines and Healthcare products Regulatory AgencyGuidance 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 AgencyAdvanced therapy medicinal products: regulation and licensing |
https://www.gov.uk/guidance/advanced-therapy-medicinal-products-regulation-and-licensing |
 |
European Medicine AgenciesScientific 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 AdministrationOversight 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 AdviceFor 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 CentresAdvanced Therapies NHS Readiness Toolkit |
https://www.theattcnetwork.co.uk/advanced-therapies-nhs-readiness-toolkit |
In this section