Transcript Regulatory Requirements – Tanzania Food and Drugs Authority

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
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
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
Key Regulatory Functions
Drug Registration
Drug Inspection (+
GMP) and
Surveillance
Licensing of
pharmaceutical
manufacturers,
importers and
distributors
Control of
importation of
pharmaceuticals
Quality Control
Laboratory
Pharmacovigilance
(Adverse Drugs
Reactions)
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
Technical information required in
registration dossiers
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)
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
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
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
failed cGMP
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 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
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
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)
GPHF Minilab Launch
Oct, 2002
QA Program to strengthen PMS
Key areas of the
Assurance program
Drug
Quality
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.
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.
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)
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
place
PDA system for POE inspectors in use
Now gets financial support from Global Fund
Buy more kits and HPLCs, densitometer, training,
etc
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
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
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
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
THANK YOU VERY MUCH