The Italian Medicines Agency participated in the drafting of the 47th annual report dedicated to the guidelines on pharmaceutical production (47th Technical teport - "Who expert committee on specifications for pharmaceutical preparations"), bearing witness to the consolidated relationship existing with the World Organization of health (WHO). The WHO Expert Committee works to produce clear, practical and independent standards and guidelines to ensure the quality of medicines. The standards are developed by the Committee through a worldwide consultation and consensus building process. Specifically, AIFA participated in the drafting of the contribution relating to the section dedicated to Quality risk management, a fundamental requirement for guaranteeing compliance with the Good Manufacturing Practices for medicinal products. Recently Aifa and WHO have also signed a collaboration agreement stipulated in the context of the "Prequalification procedures" of vaccines, further confirming the level of authority achieved by the Italian regulatory system. The complete version of the Technical report is available on the WHO website.
June 12, 2013 – Pharmacist33
