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This guideline describes the information to be included when a marketing authorisation application for SCIg/IMIg is made. It addresses biological data, pharmacokinetics, clinical trials and patient follow-up.

This guideline describes the main clinical data needed to support an application for a marketing authorisation for non-replacement therapy for use in prevention of bleeding in patients with haemophilia A and/or haemophilia B

This guideline provides medicine developers guidance on the clinical evaluation of new medicinal products for promoting weight loss in obese adult patients.

This guideline addresses the good clinical practice, an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. It aims to provide a unified standard for the ICH regions to facilitate the mutual acceptance of clinical data by the regulatory...

This guideline provides guidance on the evaluation of medicinal products in the treatment of chronic peripheral arterial occlusive disease.

The aim of this guidance is to define acceptable data requirements for the demonstration of the quality of biological veterinary medicinal products, including immunological veterinary medicinal (IVMPs) products, classified as limited markets in line with Article 4(29) of Regulation (EU) 2019/6.

This guideline clarifies the efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

This guideline clarifies the safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

The aim of this guidance is to define acceptable data requirements for the demonstration of safety and efficacy of immunological veterinary medicinal products (IVMPs) classified as limited markets in line with Article 4(29) of Regulation (EU) 2019/6 but not eligible for authorisation under Article 23 of same Regulation.

The objective of this concept paper is to identify aspects that are specific for tRPs that need to be addressed in the future guideline, to complement the more general guideline on the clinical evaluation of anticancer medicinal products (EMA/CHMP/205/95 Rev.6). The scope of the guideline is to provide specific guidance on how the key concepts from...