Transcript Slide 1

NRA in BTSs of the EMR
Dr. Nabila E. Metwalli
Regional Advisor / Blood Safety
WHO / EMRO
Cairo, Egypt
and
Dr. Abdel Aziz Saleh
WHO / EMRO Advisor
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Strategy Components
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Medicines policy
Access
Quality and safety
Rational use
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WHO Medicinal Quality
Assurance Program
Quality and Safety
The quality, safety and
efficacy of all medicines
are assured by
strengthening and
putting into practice
Regulatory and Quality
assurance standards
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The Hisba System in Islamic
Countries
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
QUALITY & SAFETY
To assure the quality, safety and efficacy of
all medicines: medicines should undergo
strengthening; putting into practice regulatory
and quality assurance standards
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”
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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
Legal Framework
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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
The efficient National Vaccine Regulatory Authority
should perform the following functions within an
efficient Regulatory system:
• Marketing authorization & licensing
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activities,
Post marketing: AEFI,
Lot release,
Laboratory access,
Regulatory inspections, and
Authorization & monitoring of Clinical
Trials.
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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
Blood Derived Medicinal Products
Regulations
MEDICINES Regulatory
Authority
MEDICINES Regulations
BLOOD Derived Products
äAP/QSD/01
Blood Products: Regulation Overview
Problems and Limitations
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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)
Quality Assurance of Biologicals: Blood
Products
Starting material
Production
Process
Final product
consistency
Blood collection &
Plasma quality &
safety
Fractionation
Technology/ Viral
inactivation /Removal
Procedures
Product characteristics:
Bulk & Formulated
Product
REGULATORY CONTROL OF
PLASMA FOR FRACTIONATION
Role of national regulatory
authorities
NRAs 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
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, postgraduate & 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
Thank you
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