Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Close this folderSafety of blood-derived products
View the documentQuality and safety of plasma for fractionation
View the documentProcedures for inactivation and removal of viruses
View the documentGMP in blood plasma collection centres
View the documentPlasma fractionation - Brazilian programme of self-sufficiency in blood products
View the documentSafety of blood products in New Zealand
View the documentRegulatory experience in Argentina
View the documentSafety of blood products in the Islamic Republic of Iran
View the documentRecommendations
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

Safety of blood products in the Islamic Republic of Iran

Dr A. Kebriaeezadeh, Islamic Republic of Iran

Blood products are regulated by the Iranian Blood Transfusion Organization (IBTO) and the National Regulatory Authority (NRA), both of which belong to the Ministry of Health.

Blood products may be either locally manufactured or imported. All such products need to be registered and approved by the NRA for marketing. An establishment licence issued by the NRA is needed by manufacturers, importers and distributors. The NRA is also responsible for conducting batch release testings. Documentation and other requirements for registration are very similar for locally made and imported product, and include the site master file, drug master file, GMP certificate. A CPP (certificate of a pharmaceutical product) from the country of origin and a list of countries where the product is registered and/or marketed are also required.

In the Islamic Republic of Iran, manufacturers of blood products must have an establishment licence for their production facility. Most importantly, before a marketing authorization for blood products can be granted, a rigorous review of their safety, quality and efficacy by the NRA is essential.

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