The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the International Society of Pharmacovigilance (ISoP) have signed a Memorandum of Understanding (MoU) to formalise their strategic collaboration to strengthen global awareness, recognition and adoption of ICH Guidelines, with a focus on pharmacovigilance, medication safety and MedDRA, a standardised international medical terminology produced by ICH.<\/p>\n
The collaboration reflects a shared commitment to supporting the implementation of harmonised technical requirements for pharmacovigilance and patient safety through education, outreach and scientific exchange. Under the MoU, ICH and ISoP will work together to facilitate the exchange of information, encourage collaborative activities and share expertise to support global harmonisation based on ICH Guidelines related to pharmacovigilance and patient safety.<\/p>\n
\u201cAs the global regulatory and healthcare landscape continues to evolve, collaboration is essential to ensure that harmonised guidelines are understood and implemented consistently around the world,\u201d said ICH Assembly Chair Dr Gabriela Zenh\u00e4usern (Swissmedic, Switzerland). \u201cThis collaboration with ISoP brings together complementary expertise that will help strengthen awareness of ICH Safety Guidelines and support effective implementation across diverse stakeholder communities.\u201d<\/p>\n
The two organisations intend to jointly promote awareness and implementation of ICH Guidelines and key priorities through joint participation in scientific meetings, educational programmes, targeted communications, webinars and other outreach activities. The emphasis will be on pharmacovigilance, medication safety, medication errors, expedited adverse event reporting and MedDRA.<\/p>\n
Dr Omar Aimer, President of ISoP, welcomed the agreement, stating, \u201cISoP is committed to fostering excellence in pharmacovigilance and patient safety globally. By formalising our collaboration with ICH, we can further support education, scientific exchange and capacity building, helping stakeholders worldwide better understand and implement harmonised approaches to medicine safety.\u201d<\/p>\n
The MoU underscores the shared vision of ICH and ISoP to enhance global cooperation, strengthen knowledge sharing and advance the consistent implementation of internationally harmonised standards that contribute to pharmacovigilance and medicine safety for patients worldwide.<\/p>\n
About ICH<\/strong><\/p>\n The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)<\/strong> brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical development.<\/p>\n Through expert Working Groups, ICH develops harmonised guidelines to ensure safe, effective, and high-quality medicines worldwide. ICH also develops standards such as MedDRA, a medical terminology for drug safety reporting and other pharmacovigilance applications, and supports electronic standards for regulatory information.<\/p>\n Since its creation in 1990, ICH has produced numerous guidelines that are used globally and continues to expand its membership and areas of activity.<\/p>\n For further information about ICH, please contact the ICH Secretariat at media@ich.org<\/strong>.<\/p>\n About ISoP<\/strong><\/p>\n The International Society of Pharmacovigilance (ISoP) is an international non-profit scientific organisation, which aims to foster pharmacovigilance both scientifically and educationally, and enhance all aspects of the safe and proper use of medicines, in all countries.<\/p>\n