Pharmaceutical regulatory affairs consulting services Poland

Pharmaceutical consulting Poland

EMA scientific guidelines

► Scientific guideline: Draft guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicinal products, draft: consultation open

► Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations II: Biological medicinal products, adopted

► Scientific guideline: Draft questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies, draft: consultation open

► Scientific guideline: Guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer - Revision 1, adopted

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

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