Transcript Regional Plan for Regulatory System For Blood, Blood Components

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)