2 nd South Sudan Health Sector Summit Juba Bridge Hotel, Juba 4 th -6 th December, 2013

1. 2nd South Sudan Health Sector SummitJuba Bridge Hotel,Juba4th -6th December, 2013 South Sudan Drug & Food Control Authority: Overview of the Regulatory Body

2. Presentation Outline • Background of DFCA • Organizational structure of the DFCA • Main Objective • Main activities • Finance & Administration Directorate • Challenges

3. Establishment of DFCA • DFCA is established by Drug and Food Control Authority Act No. 37, 2012 • Chairperson appointed by presidential decree No. 43/2012 • The Board, Secretary General and the Secretariat appointed by Ministerial order No. 11/2012 and 12/2012

4. Main Objective of the DFCA • To exercise general supervision, control and co-ordination over all matters relating to the pharmaceutical industry and to be the principal instrument of Government in the implementation of all policies relating to drugs, poisons, chemicals, cosmetic and foods meant for human or animals use.

5. Governance • The Authority is governed by a 21-member multi-disciplinary Board • Chairperson • Secretary General • Pharmacists (hospital; community; industry/ research; academia; MOH) • Physician • Pediatrician • Dentist • Veterinary surgeon/ doctor • Nutritionist • Environmentalist/ public health officer • Lawyer • Financial expert

6. Secretariat • Responsible for day-to-day implementation of the DFCA Act • Headed by Secretary General • Reports to the Board • Organized into five (5) Directorates, each headed by Director General • Directorate for Administration and Finance • Directorate for Licensing and Registration • Directorate for Marketing Authorization • Directorate for Inspection and Surveillance • Directorate for Quality Control Laboratory • Other important units include: • Internal Auditor • Legal Advisor

7. BOARD SECRETARIAT Directorate of Licensing & Registration Issuance /control of licenses Maintenance of all registers State level coordination Directorate of Marketing Authorization Product evaluation for registration (Human & Veterinary) Directorate of Inspection & Surveillance Inspection Post-marketing surveillance Regulatory enforcement Directorate of Finance & Administration Business support services Management processes Directorate of Quality Control & Assurance Quality control testing (central & ports of entry); Quality management system

8. Secretariat Organogram Chairperson Board Legal Advisor Secretary General Internal Auditor Director General of Finance & Administration Director General of Inspection & Surveillance Director General of Marketing Authorization Director General of Quality Control Laboratory Director General of Licensing & Registration Director of Product Registration for Human Director of Inspection Director of Product Registration for Veterinary Director of Surveillance Director of Quality Control Laboratory Director of Registration/ Licensing Director of Human Resource Management Director of Finance Director of Administration Deputy Director of Human Resource Management Deputy Director of Finance Deputy Director of Quality Assurance Deputy Director of Registration & Licensing Deputy Director of Quality Control Deputy Director of State Coordination Deputy Director of Inspection Deputy Director of Product Registration for Human Deputy Director of Surveillance Deputy Director of Product Registration for Veterinary Deputy Director of Administration

9. Main Activities • Advise the Minister of Health on matters concerning control and regulation of Regulated Products • Provide regulations, rules, guidelines and SOPs for controlling the manufacture, import/export, distribution and use of Regulated Products and necessary steps to prevent misuse and abuse

10. Main Activities (cont) • Inspect and license all manufacturing premises, importing agents, wholesalers, distributors, medical stores and dispensing areas within health facilities, pharmacies and retail outlets dealing in the Regulated Products

11. Main Activities (cont) • Grant, after due assessment, Marketing Authorization or registration status for Regulated Products, locally manufactured or imported destined for the national market or export • Monitor and inspect the market for presence of illegal, counterfeit, substandard or adulterated Regulated Products

12. Main Activities (cont) • Provide a process for sampling, analyzing and testing Regulated Products • Levy fees for licensing of Pharmaceutical businesses, Marketing Authorization and fines for non-compliance with regulations

13. Main Activities (cont) • Collaborate and cooperate with line Ministries and institutions on proper implementation of DFCA Act;

14. Secretariat Core Tasks Provision of Regulatory Services Management Processes Strategy Governance Planning Accountability Licensing of manufacturers, importers and distributers Authorizing the marketing of pharmaceutical products Performing regulatory inspection and enforcement activities Performing quality control testing on products Monitoring adverse drug reactions Support Processes Communication Finance Information Tech. Quality mgt Human Resource

15. Finance, Administration & Human Resource Management Directorate • Departments • Finance • Human Resource Management • Administration • Core functions • Human resource management • Financial management • Management information system • Procurement, logistics & administration • Coordination with technical directorates • Coordination with line Ministries, development partners & regulated clients • Customer care/ reception • Monitoring & evaluation

16. Collaboration with SMOH • DFCA Act delegates responsibility for inspection & licensing of retail pharmacies and drug shops to SMOH • DFCA plays an oversight and standards-setting role • Mechanisms for sharing information critical • DFCA expects regular reports on inspection & licensing activities, including list/ database of licensed premises • DFCA to provide technical assistance to strengthen SMOH regulatory capacity • SMOHs to share information amongst themselves • Best practices • Challenges & approaches to overcome them • Personnel registered to work within their jurisdiction

17. Key Challenges • No funds since the establishment of the Authority • Appointed staff are not yet conformed by Public Service and paid since November 2012 • Recruitment for technical staff not accomplished • No office space for DFCA to operate from including ports of entries • Lack of logistics for movement