EMA Regulatory Guidelines
Regulation
Category
Type
Date
Draft guideline on the clinical requirements for medicines intended for the treatment of sickle cell disease
Draft guideline on the clinical requirements for medicines intended for the treatment of sickle cell disease
EMA Regulatory Guidelines · EU-wideDraft guideline on the clinical requirements for medicines intended for the treatment of thalassaemia
EMA publishes draft guidance on clinical development and evidence requirements for thalassaemia medicines.
EMA Regulatory Guidelines · EU-wideICH M13B guideline on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver - Step 5
ICH M13B provides guidance on bioequivalence waivers for additional strengths of immediate-release solid oral medicines.
EMA Regulatory Guidelines · EU-wide
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