What is Pharmacovigilance?

The ICH And Pharmacovigilance

ICH is an abbreviation for the “International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use”[1].

It is an international Standards Development Organisation (SDO) that exists to promote the harmonisation of requirements for the registration and and on-going regulation of pharmaceuticals across the major global regions (EU Japan and USA). This page provides an introduction to ICH and some of its key publications.

What Is ICH?

ICH brings together regulators and Industry professionals from the global regions to participate in scientific debate on pharmacovigilance methodologies and procedures to be used to monitor and ensure the safety, quality and efficacy of medicines intended to treat humans[2].

The rationale behind its formation was the growing understanding within scientific communities that the goals of pharmacovigilance services would be better met if there existed a greater degree of uniformity regarding testing and safety regulations across the different regions[3]. ICH was therefore established in 1990[2] and has since facilitated professionals from the three global regions to formulate appropriate practice guidelines. Participants in ICH are organised as working groups, including regulatory authority and pharmaceutical industry representatives from each of the three regions, together with representatives of World Health Organisation and other bodies acting as observers.

It is important to note that ICH guidelines in themselves have no regulatory or legal mandate, but the later versions of the guidelines (‘Step 4’ in the stepwise consensus-building process) are intended for adoption and implementation by regulators in the 3 regions.  Indeed, ‘step 5’ is reached when an ICH guideline has been incorporated in regulation in the constituent regions.

The “E Series”: Important Published Standards For EU Drug Safety Work

The ICH has published a number of documents setting standards for safety, both clinical and pre-clinical. Pre-clinical guidelines have an “S” designation e.g. S1, S2 etc.  It should be noted that the clinical safety guidelines are designated as “E”, standing for “Efficacy”, which is confusing for the uninitiated, as there are also E guidelines that concern efficacy only. Each of the following clinical safety guidelines reached step 4 status. Each has an identifying code, and during the lifetime of the ICH the codes have already been revised to reflect the development and evolution of those standards documents[4]:

  • E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions
  • E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
  • E2B (R2) Maintenance of the Clinical Safety Data Management including Data Elements for Transmission of Individual Case Safety Reports
  • E2B (R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
  • E2C (R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
  • E2C (R2) Periodic Benefit-Risk Evaluation Report
  • E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
  • E2E Pharmacovigilance Planning
  • E2F Development Safety Update Report

These documents provide a high degree of detail about the expected manner, method, timing, frequency and circumstances in which pharmaceutical companies and other relevant parties need to report suspected adverse reactions and other vital clinical data to the regulatory authorities. As well as the clinical safety guidelines above, the ICH also focuses on other distinct areas. It has contributed a tremendous volume of guidelines for medicinal product Efficacy, and Quality. There is also a series of ‘Multidisciplinary’ guidelines, meaning topics which have the inevitable overlap between at least two categories from Safety, Efficacy or Quality. These include the widely used M1 guideline, which in fact is the MedDRA medical terminology (Medical Dictionary for Regulatory Activities) and the M2 guideline, which specifies the technical framework used for the electronic transmission of safety information, as well as guidelines setting standards for other key elements of pharmaceutical regulatory activities, such as data elements for drugs dictionaries and the Common Technical Document comprising the registration dossier for new medicines.

Please note that this page cannot provide detail on the full scope of the ICH guidelines and the interested reader is referred instead to the source material which can be found online at the ICH website, detailed in the references below. Please note that this page should not be considered as professional pharmacovigilance advice.

[1] ICH. (undated) ICH Home Page [online]. ICH. Available at:
http://www.ich.org/home.html [Accessed 30/08/2017].

[2] ICH. (undated) Mission [online]. ICH. Available at:
http://www.ich.org/about/mission.html [Accessed 30/08/2017].

[3] ICH. (undated) The Need to Harmonise [online]. ICH. Available at:
http://www.ich.org/about/history.html [Accessed 30/08/2017].

[4] ICH. (undated). ICH Guidelines. [online]. ICH. Available at:
http://www.ich.org/products/guidelines.html [Accessed 30/08/2017].