Support to regulatory authorities
National Medicines Regulatory Authorities and manufacturers face two challenges in ensuring the quality and safety of blood products and related in vitro diagnostic devices.
First, the risk of contamination through blood-borne pathogens like HIV, hepatitis B and hepatitis C which cause life threatening diseases world wide. Second, the difficulties in validating quality assurance systems due to the inherent variability of biological products.
National Regulatory Authorities need to be competent, independent, with strong political backing and have clear authority to develop and enforce appropriate regulations. They also need to interact closely with medical and scientific institutions and civil society organizations representing health care users and professionals in the countries.
Unfortunately, the National Regulatory Authorities in many countries often do not have this type of professional structure. Efforts should therefore be made to strengthen technical capacity and expertise of National Regulatory Authorities worldwide. Technical and regulatory guidance is provided on main topics in this Web Site (see left side). Information is also available in the Recommendations made by the International Conference of Drug Regulatory Authorities (ICDRA) that has served, since 1980, as a global forum to meet and discuss ways of strengthening collaboration.
Technical and Regulatory Assistance to National Regulatory Authorities
- WHO Recommendations for the Production, Control and Regulation of Human Plasma for Fractionation
WHO Guidelines for national authorities on quality assurance for biological products. TRS No 822, Annex 2 (Adopted by ECBS 1991)
Regulation and licensing of biological products in countries with newly developing Regulatory Authorities; Technical Report Series (TRS) No 858, Annex 1 (Adopted by the ECBS 1994)
- Eleventh International Conference of Drug Regulatory Authorities (ICDRA); Workshop on Assuring quality and safety of blood products. Madrid, Spain (2004)
Strengthening National Regulatory Authorities, AIDE-MEMOIRE, WHO (May 2003)
- Tenth International Conference of Drug Regulatory Authorities (ICDRA); Workshop on Safety of blood-derived products. Hong Kong, China (2002)
- Ninth International Conference of Drug Regulatory Authorities (ICDRA); Workshop on Safety issues of plasma-derived medicinal products. Berlin, Germany (1999)