Dr. Herbert Schmidt
Technical Officer, Health Products Policy and Standards
World Health Organization
Switzerland
The World Health Organization develops and promotes international standards for pharmaceutical products, in support of efforts to increase access to quality-assured medicines for all, and to safeguard patients from substandard and falsified medicines. The International Pharmacopoeia is a key output of this work.
Pharmacopoeias provide public standards (written norms as well as physical reference standards), which ensure the quality of medicines by defining the attributes that are essential to their safety and efficacy. They consist of analytical methods to test for the identity, purity and content of pharmaceutical products, together with acceptance criteria to evaluate test results and information about storage, labelling and production. Pharmacopoeias greatly facilitate the development of multi-source medicines (generics) by defining minimum quality standards that a group of medicines must meet in order to be considered of commensurate safety, quality and effectiveness as the originator product(s).
The added value of The International Pharmacopoeia lies in its focus on monographs of particular relevance to low- and middle-income countries which may not have sufficient resources to develop national pharmacopoeias. In a globalized world, where medicines and health products are frequently sourced from several countries with differing regulatory standards and requirements, and when the response to Public Health Emergencies of International Concern, like the COVID-19 pandemic, necessitates swift and equitable access to urgently needed quality-assured therapeutics, such a resource is indispensable.
About the speaker:
Dr Herbert Schmidt is a pharmacist and earned his PhD in 1997 in analytical chemistry at the University of Münster / Germany.
Between 1997 and 2007, he served as a laboratory manager at two German Official Medicine Control Laboratories in the quality control and quality assurance of medicines. From 2007 to 2010, he gained experience as a GxP inspector at the local authority in Düsseldorf, Germany, where he was responsible for the enforcement of the German medical devices and drug law.
Since July 2010, Dr Herbert Schmidt has been working for the Norms and Standards for Pharmaceuticals Team at the World Health Organization. His work areas are the development of specifications for The International Pharmacopoeia and the International Chemical Reference Substances.