NRA in BTSs of the EMR

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NRA in BTSs of the EMR

• Dr. Nabila E. Metwalli
• Regional Advisor / Blood Safety
• WHO / EMRO
• Cairo, Egyptand
• Dr. 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 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

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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

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NRA/Quality assurance and program development
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National Regulatory Authority (NRA)Regional
Experience
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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

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Integrated approach to comprehensive national
drug regulatory authority
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National Drug Regulatory Authority

• The drug regulatory authority (DRA) is the agency
  that develops and implements most of
  legislations and regulations on pharmaceuticals.
  Its 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.

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Core elements of drug regulation 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
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Medicines Regulation
Legal Framework

• 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/effica
  cy medicines
• Legal terms conditions to revoke or cancel
  product licences and legal sanctions
• Mechanisms for ensuring transparency and
  accountability of regulation

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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.

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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.

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Integrated approach to a comprehensive a
national drug regulatory authority
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Blood Derived Medicinal Products Regulations
Medicines
MEDICINES Regulatory Authority MEDICINES
Regulations BLOOD Derived Products
Biologicals
Blood Products

• AP/QSD/01

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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

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Main stakeholders contribution to quality
safety

• Blood National Programs
• Fractionators (responsible for defining the
  quality)
• Regulatory Authorities (enforcing regulations)

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Quality Assurance of Biologicals Blood Products
Blood collection Plasma quality safety
Starting material
Fractionation Technology/ Viral inactivation
/Removal Procedures
Production Process
Product characteristics Bulk Formulated
Product
Final product consistency
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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.
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• 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,

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CONCLUSIONS

• 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.

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CONCLUSION

• 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.

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CONCLUSIONS (cont.)

1. Member States to consider the establishment of a
   comprehensive National Drug Regulatory Authority
   with specialized departments for biologicals
   (vaccines) and blood products.
2. Pharmacy schools and human resource development
   programmes to develop national expertise in these
   areas.

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Suggested National Workplan

• A proposed frame work for the National Work Plan
• Statement of the National Objective
• Develop/Update National Legislation, required to
  regulate all activities related to Blood Blood
  Products
• 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..)

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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.

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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)

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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

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Thank youmetwallin_at_emro.who.int