Regional Plan for Regulatory System For Blood, Blood Components and Blood Products Objective/Target: By 2012 all member states will have in place a functioning Regulatory system for Blood, Blood Components and Blood products as an integral section of the integrated Regulatory system that covers medicines, Biologicals, Blood, Blood components and Blood products, Diagnostic and medical devices….

Main Activities  Situation Review  Member states are requested to prepare a report on existing situation of regulatory system of Blood, Blood components and Blood products. This include a) available laws, legislation and regulations that regulate and ensure the quality of Blood. Blood components and Blood products; b) available components of national quality assurance system of Blood, Blood components and Blood products, such as inspectorate dept., Lab testing facilities, haemovigilance …..; c) human resource and national expertise.

A proposed frame work for the National Work Plan  a) Statement of the National Objective.  b) Develop/Update national Legislation, required to regulate all activities related to Blood & Blood Products.  c) Develop/Update the National Quality assurance system, for Blood & Blood Products, within the national Drug QA System (product registration, facility and licensing).  d) Develop/Update the legal framework for GMP for Blood & Blood Products manufacturing, as a special section, of the National GMP Guidelines.

A proposed frame work for the National Work Plan  e) Develop & upgrade the National Expertise and National System for Inspection, of Blood & Blood Product Establishments.  f) Develop and upgrade the National Expertise and capabilities for Blood & Blood Product QC testing.  g) Develop and implement a National Programme for training in various aspects, of Blood & Blood Product QA system. This can include undergraduate, postgraduate and In-Service training (CME)