EMA 'Completely Reworks' Parts Of Gene Therapy Products Guideline
The European Medicines Agency has revised several sections of its 2001 guidance on the development and evaluation of gene therapy medicinal products based on stakeholder feedback and to address issues in light of the experience gained with these products.
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Use of historical controls and alternative study designs are allowed, but randomized control trial is preferred.
EMA Close To Finalizing Gene Therapy Products Guidance; No Scope For Further Approximation To International Norms
The European Medicines Agency says there is no scope to harmonize further its guidance on gene therapy medicinal products with international norms as the main focus of the document is on fulfilling data requirements to support an EU marketing authorization application.
The UK MHRA has approved its first drug under an international work-sharing initiative that also includes regulators from Australia, Canada, Singapore and Switzerland.