Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues

This guideline replaces 'Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues' Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues

Draft guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products

Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues

Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues

Regulations governing veterinary medicinal products containing genetically modified organisms in the European community.

This paper describes particular aspects of the marketing of veterinary medicinal products (VMPs) that contain or consist of genetically modified micro-organisms (GMMs) or genetically modified organisms (GMOs). The regulatory requirements and the procedures applied in the European Union for each phase (pre-marketing, authorisation process, and post-authorisation labelling and monitoring) are exp...

Clinical guideline for Non- pharmacological pain management of trauma patients in pre hospital setting

 Aims and background: Pain management is the core of care in traumatic injuries, which unfortunately is not properly managed in the pre-hospital stages. The use of pharmacological pain management by emergency medical technicians in the Iran is also subject to widespread restrictions and prohibited, so focusing on nonpharmacological pain management techniques can help improve pain management and...