Pharmaceutical regulatory affairs consulting services Poland

EMA scientific guidelines monthly revision

Documents adopted

► Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders

► Guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines

► Guideline on the clinical investigation of medicinal products for the treatment of attention deficit hyperactivity disorder (ADHD)

► Questions & Answers: positions on specific questions addressed to the EWP therapeutic subgroup on pharmacokinetics

► Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)

Open for consultation/draft

► Guideline on setting specifications for related impurities in antibiotics

► CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products

► CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products

► ICH Topic Q 3 C (R4) Impurities: Guideline for residual solvents PDE Cumene: Step 3

More details and source documents available on EMA website (see links section).