title: The harmonization of the regulation of blood products: a European perspective.
abstract: The development of blood products as medicines initially took place on the national level in various countries, which resulted in considerable diversity of mechanisms and stringency of regulatory oversight. The scenario changed dramatically with the catastrophic experience that severe virus infections had been transmitted by blood products world-wide. Blood products, which had been regulated differently in the member states, became subject to the European pharmaceutical legislation in 1989. A specialized directive regulating the blood transfusion sector and the collection of plasma for fractionation was enacted in 2002. The European Community, particularly the Commission and the European Medicines Agency, is continuously refining the requirements, providing detailed technical and scientific guidance. In addition, institutions of the Council of Europe play an important role in the transfusion sector, the elaboration of the European Pharmacopoeia prescriptions, and the co-ordination of Official Medicines Control Laboratory or Laboratories batch release. However, further and sustained efforts towards international harmonization are needed. There are already important mechanisms in place, such as the International Conference on Harmonization initiative, which is producing internationally recognized guidelines on central issues. Another important achievement is the common technical document format, which enables the use of uniform applications for marketing authorization. However, there is still room for progress, for example, questions regarding regulatory requirements for licensing of in vitro diagnostic devices, or mutual recognition of inspections. The World Health Organization continues to play an important role in harmonization, both substantially by the production of high-level guidance documents or the establishment of physical international standard preparations, and in a more general sense by providing a platform for international collaboration. A very important aspect is the transparency of the creation and refinement of regulatory requirements. It is currently the rule that draft legal texts, monographs and guidelines are published for a consultation period before adoption. Effort and attention are required to keep track of the developments. However, in the era of modern electronic communication tools, the necessary information can be found on websites and comments can easily be submitted. Networking and exchange of information will continue to be crucial for development and maintenance of sound and balanced regulatory requirements.
authors.affiliation: Paul-Ehrlich-Institut, Langen, Germany. seira@pei.de
authors.forename: R
authors.initials: R
authors.lastname: Seitz
authors.forename: M
authors.initials: M
authors.lastname: Heiden
authors.forename: C M
authors.initials: CM
authors.lastname: Nübling
authors.forename: G
authors.initials: G
authors.lastname: Unger
authors.forename: J
authors.initials: J
authors.lastname: Löwer
mesh_terms: D001781:Blood Component Removal / Q000592:standards; D016913:Blood Component Transfusion / Q000009:adverse effects / Q000331:legislation & jurisprudence*; D003257:Consumer Product Safety; D005060:Europe; D006801:Humans; D007391:International Cooperation; D008403:Mass Screening / Q000379:methods / Q000592:standards*; D010602:Pharmacopoeias as Topic; D011786:Quality Control; D012698:Serologic Tests / Q000379:methods