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 New Zealand

Dr Stewart Jessamine, New Zealand

The New Zealand safety provisions for blood products are: standard donor selection and screening tests, NAT (nucleic acid testing) for HIV and hepatitis C, first-pass donor testing for HTLV, adoption of FDA donor deferral criteria for new variant Creutzfeldt Jakob disease (nvCJD), universal leukodepletion, and implementation of CPMP/OIE/WHO guidelines on TSE and pharmaceutical products.

Fractionated products are supplied under contract, but there are certain risks for product supply. One of them is that New Zealand has a small regulatory agency and the country needs only small volumes of product (approximately six batches fractionated per year). In this situation, if one batch is contaminated, the stocks of the product available on the market will be significantly reduced.

One of the specific safety issues in New Zealand is risk management in relation to nvCJD. However, risks are defined by other countries contracting with the fractionator, and it is possible that standards will be driven by the most risk-averse client, with significant impact on costs.

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