2. 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

3. 3

4. 4 Strategy Components Medicines policy Access Quality and safety Rational use

5. 5 WHO Medicinal Quality Assurance Program Q uality and Safety The quality, safety and efficacy of all medicines are assured by strengthening and putting into practice Regulatory and Quality assurance standards

6. 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

7. QUALITY & SAFETY To assure the quality, safety and efficacy of all medicines: medicines should undergo strengthening; putting into practice regulatory and quality assurance standards

8. 8 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”

9. NRA/Quality assurance and program development

10. National Regulatory Authority (NRA) Regional Experience

11. 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

12. Integrated approach to comprehensive national drug regulatory authority

13. 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.

14. 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

15. 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

16. 16 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.

17. 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.

18. Integrated approach to a comprehensive a national drug regulatory authority

19. MEDICINES Regulatory Authority MEDICINES Regulations BLOOD Derived Products Blood Derived Medicinal Products Regulations ä AP/QSD/01

20. 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

21. Main stakeholders: contribution to quality & safety Blood National Programs Fractionators (responsible for defining the quality) Regulatory Authorities (enforcing regulations)

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

23. 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.

24. 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,

25. 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.

26. 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.

27. 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.

28. 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…..)

29. 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.

30. 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)

31. 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

32. Thank you metwallin@emro.who.int