Role of National Drug Regulatory Authorities in Procurement and

Supply Management

Hiiti SilloTanzania Food and Drugs Authority

(TFDA)

PSM Technical Briefing Seminar for Consultants

Wednesday, 1st February 2006

Tanzania Food and Drugs Authority (TFDA)

Established by the Tanzania Food, Drugs and Cosmetics Act, 2003.Inherited functions of defunct Pharmacy BoardAn Executive Agency under the Ministry of HealthIt 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

Technical HR capacity16 Pharmacists with MSc/M.Pharm/MPH11 Pharmacists with BPharm3 Veterinary Surgeons1 Chemist with MScTechniciansAdmin and finance staffFood technologistsHealth Officers

Key Regulatory FunctionsDrug RegistrationDrug Inspection (+ GMP) and SurveillanceLicensing of pharmaceutical manufacturers, importers and distributors

Control of importation of pharmaceuticals

Quality Control Laboratory

Pharmacovigilance (Adverse Drugs Reactions)

Drug RegistrationAccording 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 interestIt is safe, efficacious and of acceptable qualityThe site and manufacturing operations complies with current GMP (adapted WHO guidelines)

To facilitate registration process, guidelines available on www.tfda.or.tz

Technical information required in registration dossiers

GenericsCertificate of Pharmaceutical Product (CPP) – WHO typeSummary of product characteristics (SPCs)Quality of APIsQuality of finished dosage form (manufacturing, quality control, stability data, labeling, etc)Therapeutic equivalence data

New DrugsCertificate of Pharmaceutical Product (CPP) – WHO type SPCsQuality data on APIs and FP as in genericsSafety (preclinical) dataClinical data (incl. Clinical trials data)

Assessment of registration dossiers

Documents assessed Trained and qualified TFDA assessorsExternal experts from University and Research Organizations

Assessment is based on FIFO Time to register products put in guidelines

12 months if no queries raised3 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

Pre-registration GMP inspectionApplicable 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 inspectionsCriteria based on WHO guidelines

Overseas sites inspected in the last 2 years (data as of April

2005)

Year No. of sites inspected

No. of sites passed cGMP

No. of sites failed cGMP

% Failed

2003/04 35 26 9 25.71

2004/05 54 33 21 38.89

Licensing, Inspection & Surveillance

Inspections are done to ensure compliance to legal and licensing requirementsInspectors have been appointed at TFDA HQ and regional levelsThe law requires all manufacturers and distributors of pharmaceutical products to hold valid licenses/permitsPremises are inspected before licensing

Quality Control laboratory

TFDA laboratory established in 2000 has the capacity to handle most of the analytical work

Analysis of registration samplesAnalysis of PMS samplesSamples 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 stageAssessed by WHO for pre-qualification in 2005 – some gaps need to be addressed

Drug Quality Assurance Programme

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

GPHF Minilab LaunchOct, 2002

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 Department10 TLC Minilab screening sites established for product physical examinations and API identification for targeted antimalarials, antibiotics and antiretroviral drugs.

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 drugsDevelopment of inspection guidelines and SOPs at all levels.

Impact of Drug QA Programme

Overall PMS system improved through the development and use of Inspectors Handbook containing

Inspection formsSampling proceduresSOPsChecklistsEthics

Products at POEs and those in circulation comply with quality standards (see next slide)

Impact 2 Decrease in substandard drugs in the market from 13% 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 placePDA system for POE inspectors in useNow gets financial support from Global Fund

Buy more kits and HPLCs, densitometer, training, etc

Control of importationEnsures 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

Pharmacovigilance…

In Tanzania, TFDA is responsible for monitoring ADRs.Prepaid reporting forms circulated to healthcare workers in hospitalsReceived cases are assessed by expert committee which recommends appropriate regulatory action

Modification of patient information leafletsWithdrawal 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

PharmacovigilanceNew guidelines for monitoring and reporting of ADRs developedADR reporting forms revisedGlobal fund Round 4 for malaria and HIV/AIDS now supporting strengthening of the system

Other important information

Harmonization of technical requirements in EAC and SADC under progressClose work relationships with key stakeholders

National Programmes – Malaria, TB, AIDSMedical Stores DepartmentReferral and regional hospitalsSchools of Pharmacy and MedicinesLocal pharma producers & associationsMoH- Pharmaceutical Supplies Unit - NDP

THANK YOU VERY MUCH