Role of National Drug Regulatory Authorities in Procurement and Supply Management

1. Role of National Drug Regulatory Authorities in Procurement and Supply Management Hiiti Sillo Tanzania Food and Drugs Authority (TFDA) PSM Technical Briefing Seminar for Consultants Wednesday, 1st February 2006

3. Tanzania Food and Drugs Authority(TFDA) • Established by the Tanzania Food, Drugs and Cosmetics Act, 2003. • Inherited functions of defunct Pharmacy Board • An Executive Agency under the Ministry of Health • It is the regulatory body responsible for control of quality and safety of food, drugs (including herbal drugs), cosmetics, and medical devices. • Vision:To become the best regulatory authority in regulating food, drugs, cosmetics and medical devices in Africa by 2015

4. Technical HR capacity • 16 Pharmacists with MSc/M.Pharm/MPH • 11 Pharmacists with BPharm • 3 Veterinary Surgeons • 1 Chemist with MSc • Technicians • Admin and finance staff • Food technologists • Health Officers

5. Drug Registration Drug Inspection (+ GMP) and Surveillance Licensing of pharmaceutical manufacturers, importers and distributors Key Regulatory Functions • Control of importation of pharmaceuticals • Quality Control Laboratory • Pharmacovigilance (Adverse Drugs Reactions)

6. Drug Registration • According to the law • All drugs to be manufactured for sale, imported or supplied must be registered (Sect.22) • Criteria for registration is provided in the law: • Availability of the drug is in the public interest • It is safe, efficacious and of acceptable quality • The site and manufacturing operations complies with current GMP (adapted WHO guidelines) • To facilitate registration process, guidelines available on www.tfda.or.tz

7. Generics Certificate of Pharmaceutical Product (CPP) – WHO type Summary of product characteristics (SPCs) Quality of APIs Quality of finished dosage form (manufacturing, quality control, stability data, labeling, etc) Therapeutic equivalence data New Drugs Certificate of Pharmaceutical Product (CPP) – WHO type SPCs Quality data on APIs and FP as in generics Safety (preclinical) data Clinical data (incl. Clinical trials data) Technical information required in registration dossiers

8. Assessment of registration dossiers • Documents assessed • Trained and qualified TFDA assessors • External experts from University and Research Organizations • Assessment is based on FIFO • Time to register products put in guidelines • 12 months if no queries raised • 3 months for ARVs, Antimalarials and AntiTB (priority products) - evaluation fast tracked to facilitate access • Client Service Charter launched by Minister for Health on 27th Jan 2006 • Spells commitment of service delivery timeframes

9. Pre-registration GMP inspection • Applicable to both local and overseas sites before products are registered • Exception to ICH countries and some PIC/S countries – rely on documents submitted (CPP) • GMP inspection • 9 competent GMP inspections • Criteria based on WHO guidelines

10. Overseas sites inspected in the last 2 years (data as of April 2005)

11. Licensing, Inspection & Surveillance • Inspections are done to ensure compliance to legal and licensing requirements • Inspectors have been appointed at TFDA HQ and regional levels • The law requires all manufacturers and distributors of pharmaceutical products to hold valid licenses/permits • Premises are inspected before licensing

12. Quality Control laboratory • TFDA laboratory established in 2000 has the capacity to handle most of the analytical work • Analysis of registration samples • Analysis of PMS samples • Samples sent to the lab after primary screening at POEs or by other inspectors through the QA Programme • The lab is now moving towards accreditation -quality manual in final stage • Assessed by WHO for pre-qualification in 2005 – some gaps need to be addressed

13. Drug Quality Assurance Programme • Launched in 2002 for quick screening of pharmaceuticals being imported and those produced locally using simple TLC techniques • The program was technically assisted by MSH-SEAM for 3 years ending June 2005 • The Program uses Minilab Kits developed by the German Pharma Health Fund (GPHF)

14. GPHF Minilab LaunchOct, 2002

15. QA Program to strengthen PMS • Key areas of the Drug Quality Assurance program • Inspection and testing of drugs at the major Ports-of-Entry and the Medical Stores Department • 10 TLC Minilab screening sites established for product physical examinations and API identification for targeted antimalarials, antibiotics and antiretroviral drugs.

16. QA Program and Strengthening PMS • Training of drug inspectors countrywide, 329 inspectors trained. • Trained inspectors are provided with Inspectors Handbook (developed with TA from MSH – SEAM • Reviewed current guidelines for control of importation of drugs • Development of inspection guidelines and SOPs at all levels.

17. Impact of Drug QA Programme • Overall PMS system improved through the development and use of Inspectors Handbook containing • Inspection forms • Sampling procedures • SOPs • Checklists • Ethics • Products at POEs and those in circulation comply with quality standards (see next slide)

18. Impact 2 • Decrease in substandard drugs in the market from13% in 2001 for samples tested in the Laboratory to 3.7% among 1,257 screened drug samples in 2005 • Guidelines and SOPs for inspection now in place • PDA system for POE inspectors in use • Now gets financial support from Global Fund • Buy more kits and HPLCs, densitometer, training, etc

19. Control of importation • Ensures imported products are registered and authorized for importation • At POEs, inspectors check the COA to verify • whether the COA has been signed and stamped by authorized person(s) • if the reported test results are within specification limits • if products with more than 24 months shelf life have 60% of their shelf life remaining • if products with less than 24 months shelf life have 80% of their shelf life remaining

20. Pharmacovigilance… • In Tanzania, TFDA is responsible for monitoring ADRs. • Prepaid reporting forms circulated to healthcare workers in hospitals • Received cases are assessed by expert committee which recommends appropriate regulatory action • Modification of patient information leaflets • Withdrawal of the product from the market • 67 and 75 cases reported in 2003/04 and 2004/05 respectively, were normal side effects • Not required regulatory actions taken • However- serious underreporting – global problem

21. Pharmacovigilance • New guidelines for monitoring and reporting of ADRs developed • ADR reporting forms revised • Global fund Round 4 for malaria and HIV/AIDS now supporting strengthening of the system

22. Other important information • Harmonization of technical requirements in EAC and SADC under progress • Close work relationships with key stakeholders • National Programmes – Malaria, TB, AIDS • Medical Stores Department • Referral and regional hospitals • Schools of Pharmacy and Medicines • Local pharma producers & associations • MoH- Pharmaceutical Supplies Unit - NDP

23. THANK YOU VERY MUCH