In the WHO Eastern Mediterranean Region, only nine (9) countries have legislation that covers blood and blood products. Moreover, preliminary assessments conducted in two (2) of the nine countries showed that the fundamental principles of blood supply and transfusion, quality (system and management) and good manufacturing practices are not anchored in existing legislations.
These legislations are applicable mainly to blood and blood products. Plasma derived medicinal products, associated substances (e.g., anticoagulants), and medical devices including in vitro diagnostics used in blood collection, processing, storage and clinical use are not covered in these legislations. In addition, particularly for Pakistan, the Provincial blood legislations are not harmonized.
IQM Consulting invited to provide technical support
Planned timeline: 01 August – 31 October, 2017
One of the recommendations of the preliminary assessments conducted in the two countries is to conduct systematic review of blood legislations from nine countries that have legislations in place (Egypt, Iran, Jordan, Lebanon, Morocco, Pakistan, Kingdom of Saudi Arabia, Tunisia and United Arab Emirates), with the objective of providing informed feedback to countries and developing a model (template) blood legislation that can be adopted by countries. The model (template) blood legislation will facilitate harmonization and convergence of the regulatory systems across the Region.
Considering the technical expertise required for the task, WHO EMRO requires additional technical guidance by a senior expert in the field of blood regulatory system, which is not currently available within the Department/Unit.
- Conduct a systematic review of blood legislations from nine countries in the Region: Egypt, Iran, Jordan, Lebanon, Morocco, Pakistan (all provinces), Saudi Arabia, Tunisia and United Arab Emirates.
- Create a new model (template) blood legislation that will be adopted by all countries in the Region.