Body |
Description of Resource/tool |
Link |
|---|---|---|
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Medicines and Healthcare products Regulatory AgencyGuidance on licensing biosimilars, ATMPs and PMFs (latest update from May 2021) |
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Medicines and Healthcare products Regulatory AgencyAdvanced therapy medicinal products: regulation and licensing |
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European Medicine AgenciesScientific recommendations on classification of advanced therapy medicinal products |
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US Foof & Drug AdministrationOversight of clinical studies, proactive scientific and regulatory advice to medical researchers and manufacturers of advanced therapeutics |
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 |
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 |
|
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Advanced Therapies Treatment CentresAdvanced Therapies NHS Readiness Toolkit |
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