EMA/Member States governance structure for pharmacovigilance EU Individual Case Safety Report (ICSR)0F Implementation Guide. ‘ICSR’ refers to Individual Case Safety Reports which must be compiled for each instance of a suspected or Pharmacovigilance Operations – Postmarketing. Description: The HL7 Individual Case Safety Report (ICSR) Pharmacovigilance – Structure and data elements of individual case safety report.

Author: Malagul Voodoogami
Country: Austria
Language: English (Spanish)
Genre: Travel
Published (Last): 7 July 2012
Pages: 56
PDF File Size: 15.68 Mb
ePub File Size: 9.19 Mb
ISBN: 376-9-28359-889-1
Downloads: 26665
Price: Free* [*Free Regsitration Required]
Uploader: Branos

VigiBase is the single largest drug safety data repository in the world. Vigibase is used to obtain the information about a safety profile of a medicinal product.

These data are used by pharmaceutical industries, academic institutions and regulatory authorities for statistical signal detection, updating periodic reports, ICSR comparisons with company databases and studying the reporting patterns. The data is collected from each of its member states. About a hundred pharmacoviglance ICSRs are added each year.

Although somewhat intuitive, there are a set of criteria within pharmacovigilance that are used to distinguish a serious adverse event from a non-serious one.


An adverse event is considered serious if it meets one or more of the following criteria:.

Pharmacovigilance: Regulatory and procedural guidance

Adverse event coding is the process by which information from an adverse effect reporter, is coded using standardized terminology from a medical coding dictionary, such as MedDRA the most commonly used medical coding dictionary. The purpose of medical coding is to convert adverse event information into terminology that can be readily identified and analyzed.

However, both quotes describe different manifestations of a headache. The use of the new international standard has taken effect on 1 July ISO ICSR aims at establishing the same format for the reports on individual cases of suspected side effects in patients due to a medicine across the world.

Individual Case Study Report (ICSR) Seriousness and Coding

It also is expected to include better information on medicines that might be associated with an adverse drug reaction and on the therapeutic uses of those pharmadovigilance.

In addition, the standard also strengthens personal data protection in the records of ICSRs collected by pharmaceutical companies and regulatory authorities. This will improve the quality of data collected, and increase the ability to search and analyse them.


Regulatory authorities will be able to detect and address safety issues with medicines more quickly, and therefore better protect patients. The new guide icsf jointly by EMA and the Heads of Medicines Agencies HMA will be of interest to pharmaceutical companies and medicines regulatory authorities in EU Member States and will support them to prepare for the use of the standard. The guide specifically defines the electronic transmission process of ICSRs, the format and content of the ICSR, the business rules for report validation as well as classification and data phatmacovigilance principles.

It will also assist software providers and IT developers as pharmacovigilance databases are being developed. Blog – Latest News You are here: Ic Id If Pharmacovigllance Is.

October – September –