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NRA in BTSs of the EMR
Dr. Nabila E. MetwalliRegional Advisor / Blood Safety
WHO / EMROCairo, Egypt
andDr. Abdel Aziz Saleh
WHO / EMRO Advisor
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Strategy Components
• Medicines policy
• Access
• Quality and safety
• Rational use
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WHO Medicinal Quality Assurance Program
Quality and Safety
The quality, safety and The quality, safety and efficacy of all medicines efficacy of all medicines
are assured by are assured by strengthening and strengthening and
putting into practice putting into practice Regulatory and Quality Regulatory and Quality assurance standardsassurance standards
The situation of Hisba was developed to carry out the function of stewardship in
Islamic Countries more than 1400 years ago.
Medical Services were also regulated by the Hisba System
The Hisba System in Islamic Countries
QUALITY & SAFETY
To assure the quality, safety and efficacy of all medicines: medicines should undergo
strengthening; putting into practice regulatory and quality assurance standards
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Quality System
Most developing countries lack the comprehensive set-up of a national quality
system as defined by WHO “An appropriate infrastructure, encompassing the
organizational structure, procedures, processes and resources necessary to
ensure adequate confidence that a product (or service) will satisfy given requirements
for quality”
NRA/Quality assurance and program development
National Regulatory Authority (NRA)
Regional Experience
Definition of a “DRUG”
Any chemical compound that may be used on/or administered to
humans or animals, as an • Aid in diagnosis, treatment, or prevention of disease; &/or other pathologic conditions•Aids in the relief of pain &/or suffering•Controls & improves physiologic or pathologic conditions
Integrated approach to comprehensive national drug
regulatory authority
National Drug Regulatory Authority
The drug regulatory authority (DRA) is the agency that develops and implements most of legislations and regulations on pharmaceuticals. It’s main task is to
ensure the quality, safety and efficacy of drugs, and the accuracy of product information. This is done by making
certain that the manufacturer; procurement, import, export, distribution, supply, sale of drugs, product
promotion, advertising, and clinical trials are carried out according to specified standards.
Core elements of drug regulation
Quality: •Review of quality as part of product registration; •Formulation of norms and standards;•Licensing of facilities and personnel;•Inspection of facilities and products;•Drug quality control
Safety: •Review of safety as part of product registration;•Adverse drug reaction monitoring;•Issue of warning, recall of products
Efficacy: •Review of efficacy as part of product registration;•Authorization of clinical trials
Information: •Review and approval of product data sheets and labels;•Regulation of advertising and drug promotion
Medicines Regulation
• Mission statement: state purpose of medicines regulation• Medicinal product categories & activities to be regulated • Legal provision for creation of an NRA• Norms & standards supporting quality/safety/efficacy
medicines• Legal terms & conditions to revoke or cancel product
licences and legal sanctions• Mechanisms for ensuring transparency and accountability of
regulation
Legal Framework
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The efficient National Vaccine Regulatory Authority should perform the following functions within an
efficient Regulatory system:
• Marketing authorization & licensing activities,
• Post marketing: AEFI,• Lot release,• Laboratory access,• Regulatory inspections, and• Authorization & monitoring of Clinical
Trials.
The control of biologicals should be a comprehensive process involving
the licensing authority, inspectorate, control laboratory, and epidemiological monitoring units with constant interaction
between these. The development of a control system may be a
phased process with initial emphasis on safety assurance and
low technology processes.
Integrated approach to a comprehensive a national drug regulatory authority
MEDICINES Regulatory Authority
MEDICINES Regulations
BLOOD Derived Products
Blood Derived Medicinal Products Regulations
AP/QSD/01
Blood Products: Regulation Overview
Problems and Limitations
• No legislation/regulation available • Legislation/regulation existing but inadequate• Legislation/regulation available but not implemented• Sensitivity of blood transfusion services to regulatory authority
control• GMP has not been a natural background for blood transfusion • Lack of government awareness: rationale for regulation• Lack of technical capacity of regulatory authorities
Main stakeholders: contribution to quality & safety
• Blood National Programs
• Fractionators (responsible for defining the quality)
• Regulatory Authorities (enforcing regulations)
Fractionation Fractionation Technology/ Viral Technology/ Viral inactivation /Removal inactivation /Removal ProceduresProcedures
Starting materialStarting material
Production Production ProcessProcess
Final product Final product consistencyconsistency
Product characteristics:Product characteristics:Bulk & Formulated Bulk & Formulated Product Product
Blood collection & Blood collection & Plasma quality & Plasma quality & safetysafety
Quality Assurance of Biologicals: Blood Products
REGULATORY CONTROL OF PLASMA FOR FRACTIONATION
Role of national regulatory authoritiesNRAs have the duty to ensure that available biological products, whether imported or manufactured locally, are of good quality, safe and efficacious, and should thus ensure that manufacturers adhere to approved standards of quality assurance and good manufacturing practice.
• An adequate system to ensure traceability of plasma should be established; traceability should be enforced through accurate donor, donation, product and laboratory sample identification procedures, through record maintenance, and through an appropriate labeling system,
CONCLUSIONS
A. WHO should promote the concept of one Comprehensive National Drug Regulatory Authority that regulates all medicines and diagnostic agents including vaccines, blood products and other biologicals. A coordinated approach is needed at various WHO levels.
CONCLUSION
A. WHO should promote the concept of one Comprehensive National Drug Regulatory Authority that regulates all medicines and diagnostic agents including vaccines, blood products and other biologicals. A coordinated approach is needed at various WHO levels.
CONCLUSIONS (cont.)
B. Member States to consider the establishment of a comprehensive National Drug Regulatory Authority with specialized departments for biologicals (vaccines) and blood products.
C. Pharmacy schools and human resource development programmes to develop national expertise in these areas.
Suggested National Workplan
• A proposed frame work for the National Work Plan:
1.Statement of the National Objective
2.Develop/Update National Legislation, required to regulate all activities related to Blood & Blood Products
3.Develop/Update the National Quality Assurance System, for Blood & Blood Products, within the national Drug QA System (product registration facility licenseing & inspection; QC testing, etc…..)
Suggested National Work Plan (cont.)
4. Develop/Update the legal framework for GMP for Blood & Blood Products manufacturing, as a special section, of the National GMP Guidelines
5. Develop & Upgrade the National Experties & National System for Inspection, of Blood & Blood Product Establishments.
Suggested National Work plan (cont.)
1. 6. Develop & Upgrade the National Expertise & Capabilities for Blood & Blood Product QC testing
2. 7. Develop & Implement a National Program for Training on Various Aspects, of Blood & Blood Product QA System. This can include undergraduate, post-graduate & In-Service training (CME)
Suggested National Work plan (cont)
• Situation Review: Member States with WHO support to develop a National Report on the Situation of Blood & Blood Products Regulation
• Based on the Situation Review Report, Member states with WHO support, to develop an appropriate National Work plan on Blood & Blood Products
