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
 

Recommendations

Plasma-derived medicinal products, as well as blood and blood components, should be regulated in the same way as other biological products and fall under the responsibility of regulatory authorities.

The importance of good manufacturing practice (GMP) was emphasized. The main problem identified was how best to minimize the risk of transmitting currently known and emerging blood-borne diseases. Developing countries in particular, had difficult choices to make in planning balanced regulatory action.

1. WHO should promote the regulation of blood and plasma collection centres, with emphasis on ensuring GMP compliance.

2. Regional co-operation and training should be promoted and WHO should facilitate the development of educational programmes and training opportunities for staff involved in regulation and control of blood products.

3. WHO should collaborate with Member States to strengthen the technical expertise of regulatory authorities (especially those countries with plasma fractionation activities/facilities) to assure adequate quality, safety and efficacy of plasma products. Special emphasis should be placed on viral testing, viral inactivation procedures, and surveillance for viral and other transfusiontransmitted diseases. Special attention should be given to the possible risk of transmission of vCJD and appropriate validation studies should be carried out.

4. In those countries where contract fractionation of plasma is a common option, WHO should develop guidance on the regulatory issues involved.

5. In order to facilitate approval by regulatory authorities of importation of plasma products, WHO should promote the use of batch release certificates, with a clear description of the procedures used.

6. Progress should be reported back to the ICDRA.

 

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