This guideline describes specific aspects of pharmacovigilance, risk management planning, safety and efficacy follow-up of authorised ATMPs, as well as some aspects of clinical follow-up of patients treated with such products. Full document...

This guideline acknowledges the constraints put on clinical drug development imposed by the high rate of mutations of HCV and therefore emphasises the importance of taking the risk of selecting for resistant variants into account in the design of clinical studies, including the possible use of adding more than one DAA to SOC. Full Document...

The guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CPMP/42832/05/) lays down the general requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy. Full document...

The guideline is a revision of the CPMP Points to Consider on the Requirements for Clinical documentation for Orally Inhaled Products (OIP) CPMP/EWP/4151/00. It clarifies the requirements for clinical documentation for abridged applications of orally inhaled formulations and variations/extensions to a marketing authorisation in respect of the demonstration of therapeutic equivalence between two inhaled products for use in the management and treatment of asthma and chronic obstructive pulmonary disease. Full document...

This guideline applies to the replacement of an antigen (e.g. virus, bacteria, fungus) master seed by a master seed of the same origin. It applies also to the replacement of the master cell seed used to produce a vaccine organism by a master cell seed of the same origin. Full document...

This Guideline concerns the conduct of repeated dose toxicity studies of active substances intended for human use. Full document...

This document provides guidance on bracketing and matrixing study designs. Specific principles are defined in this guideline for situations in which bracketing or matrixing can be applied. Sample designs are provided for illustrative purposes, and should not be considered the only, or the most appropriate, designs in all cases. Full document...