Regional Plan for Regulatory SystemRegional Plan for Regulatory SystemFor Blood, Blood Components andFor Blood, Blood Components and

Blood ProductsBlood Products

Objective/Target:Objective/Target:By 2012 all member states will have in place a By 2012 all member states will have in place a

functioning Regulatory system for Blood, Blood functioning Regulatory system for Blood, Blood Components and Blood products as an integral section of Components and Blood products as an integral section of the integrated Regulatory system that covers medicines, the integrated Regulatory system that covers medicines, Biologicals, Blood, Blood components and Blood products, Biologicals, Blood, Blood components and Blood products, Diagnostic and medical devices….Diagnostic and medical devices….

Main ActivitiesMain Activities Situation ReviewSituation Review

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

A proposed frame work for the A proposed frame work for the National Work PlanNational Work Plan

a) Statement of the National Objective.a) Statement of the National Objective. b) Develop/Update national Legislation, required to b) Develop/Update national Legislation, required to

regulate all activities related to Blood & Blood Products.regulate all activities related to Blood & Blood Products. c) Develop/Update the National Quality assurance system, c) Develop/Update the National Quality assurance system,

for Blood & Blood Products, within the national Drug QA for Blood & Blood Products, within the national Drug QA System (product registration, facility and licensing).System (product registration, facility and licensing).

d) Develop/Update the legal framework for GMP for Blood d) Develop/Update the legal framework for GMP for Blood & Blood Products manufacturing, as a special section, of & Blood Products manufacturing, as a special section, of the National GMP Guidelines.the National GMP Guidelines.

A proposed frame work for the A proposed frame work for the National Work PlanNational Work Plan

e) Develop & upgrade the National Expertise and National e) Develop & upgrade the National Expertise and National System for Inspection, of Blood & Blood Product System for Inspection, of Blood & Blood Product Establishments.Establishments.

f) Develop and upgrade the National Expertise and f) Develop and upgrade the National Expertise and capabilities for Blood & Blood Product QC testing.capabilities for Blood & Blood Product QC testing.

g) Develop and implement a National Programme for g) Develop and implement a National Programme for training in various aspects, of Blood & Blood Product QA training in various aspects, of Blood & Blood Product QA system. This can include undergraduate, postgraduate and system. This can include undergraduate, postgraduate and In-Service training (CME)In-Service training (CME)