Proceedings of the Ninth International Conference of Drug Regulatory Authorities (ICDRA) - Berlin, Germany 25-29 April 1999
(1999; 102 pages) View the PDF document
Table of Contents
Open this folder and view contentsOpening Ceremony
Open this folder and view contentsGood regulatory practice
Open this folder and view contentsGood certification practice
Open this folder and view contentsCounterfeit drugs: challenges and solutions
Open this folder and view contentsCurrent issues in regulation and quality
Open this folder and view contentsInternational Conference on Harmonization: implementation and implications
Open this folder and view contentsDrug utilization studies
Open this folder and view contentsInternational Conference on Harmonization and the common technical document
Open this folder and view contentsKeynote address
Open this folder and view contentsGlobal and national efforts to reduce tobacco use
Open this folder and view contentsElectronic communication in the regulatory process
Open this folder and view contentsTransparency in monitoring the safety of medicines
Open this folder and view contentsPharmaceutical products for use in special groups
Open this folder and view contentsNeed for Bioequivalence
Open this folder and view contentsAntimicrobial resistance: battling the bugs
Close this folderSafety issues of plasma-derived medicinal products
View the documentRegulatory experience in industrialized countries: USA
View the documentRegulatory experience in industrialized countries: Germany
View the documentRegulatory experience in countries with evolving plasma-fractionation facilities
View the documentRegulatory experience in countries with no production of plasma-derived products: Malaysia
View the documentRegulatory experience in countries with no production of plasma-derived products: Zimbabwe
View the documentRecommendations
Open this folder and view contentsHerbal medicines
Open this folder and view contentsRegulation and access to essential drugs
View the documentParticipants
View the documentBack cover
 

Recommendations

1. WHO should collaborate with Member States to strengthen the technical expertise of national control authorities in the regulation of plasma products, especially those countries with plasma fractionation activities or facilities to assure adequate quality, safety and efficacy of plasma products. This includes special emphasis on viral testing, viral inactivation procedures, and surveillance for viral and other transfusion transmitted diseases.

2. WHO should promote the regulation of blood bank facilities by National Control Authorities in order to ensure compliance with GMP principles.

3. WHO should facilitate the development of educational programs and training opportunities for National Control Authorities involved in regulation and control of blood products. WHO should promote regional cooperation and training.

4. WHO should assist Member States in the development of appropriate guidelines for plasma fractionation contract activities.

5. WHO should provide guidelines on information to be included in batch release certificates in order to facilitate acceptance of imported plasma products by national control authorities.

 

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Last updated: April 24, 2012