Transcript challenges in regulating quality and rational use of antibiotics

CHALLENGES IN REGULATING
QUALITY AND RATIONAL USE OF
ANTIBIOTICS
ALLIANCE FOR THE PRUDENT USE OF ANTIBIOTICS:
INAGURAL MEETING
COURTYARD HOTEL
13th NOVEMBER 2007
M. Ndomondo-Sigonda
Director General - TFDA
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Scope
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About TFDA
Its Mission and Vision
Its Functions as MRA
Challenges
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TFDA
• Statutory organization under the MoH
responsible for regulating and ensuring quality,
safety & efficacy of food, drugs (human,
veterinary and herbal), medical devices &
cosmetic products
• Established by the Act of parliament - Tanzania
Food, Drugs & Cosmetics Act, No.1, 2003
• Followed repeal of Pharmaceuticals & Poisons
Act, 1978 and Food (Control of Quality) Act,
1988
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Its Mission & Vision
• Mission - To protect and promote public
health by ensuring quality, safety and
effectiveness of food, drugs, cosmetics
and medical devices
• Vision - To become the best authority in
regulating food, drugs, cosmetics, and
medical devices in Africa by 2015
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Key Functions of TFDA as Medicines
Regulatory Authority
• Regulation of drugs including antibiotics
encompasses a variety of functions.
• Amongst them include:
– Product evaluation & registration
– Licensing & Inspection of manufacturing
facilities & distribution channels
– Inspection and surveillance
– Quality Control (QC)
– ADR monitoring
– Control of drug promotion & advertising
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1. Product Evaluation & Registration
• Also known as marketing authorization and
product licensing
• Carried out to ensure that a pharmaceutical
product has been adequately evaluated for
safety, efficacy & quality and that the product
information provided by the manufacturer is
accurate.
• Involves evaluation of technical & administrative
data submitted about a drug product, deciding
whether to approve or reject the product and
issuing a Registration Certificate
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1. Product Evaluation……
• The overall process requires a legal
foundation, an adequate number of
qualified staff, sustainable resources, a
data retrieval system and a system to
ensure freedom from conflicts of interest,
accountability and transparency.
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2. Licensing of manufacturing,
distribution & retail sale
• Specifications regarding pharmaceutical
premises, personnel and procedures must be
followed by pharmaceutical manufacturers,
distributors and retailers if they wish to obtain
and retain their licence to operate.
• By means of these licences, TFDA control the
activities of pharmaceutical manufacturers,
importers and distributors & companies engaged
in drug promotion and advertising.
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3. Inspection & Surveillance
• Enables TFDA to monitor whether
pharmaceutical operations are carried out
in accordance with approved standards
and guidelines.
• In so doing, TFDA uncover weaknesses
and actual errors in drug production, QC,
storage & distribution of drugs.
• Activities include physical inspection and
quality-testing of product samples.
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4. Quality Control
• Controlling the quality of drugs before and after
registration has been issued, is critical for
ensuring the quality and safety of drugs.
• Access to a QC laboratory is of paramount
importance
• The capacity of a MRA to undertake quality
surveillance is also directly related to the
operational capability of the QC laboratory.
• The results of a laboratory assessment of
samples of marketed drugs permit the MRA to
evaluate the actual quality of products used in
the country and to identify problems pertaining
to drug quality.
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4. QC…….
• QC testing minimizes the amount of substandard drugs & raw materials in circulation.
• Encourage improvements in the standard of
local manufacturing - manufacturers may be
encouraged to upgrade their production sites, for
example, by the prospect of an independent
assessment of the quality of their products.
• TFDA has a laboratory which operates to ensure
that all of the above are being undertaken
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5. ADR Monitoring
(Pharmacovigilance)
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Overseeing and monitoring adverse reactions
to drugs are important mechanisms for
assessing the safety and efficacy of
pharmaceutical products.
ADR monitoring is an essential form of postmarketing surveillance for drugs already on the
market.
The existence and operation of this system is
important in drug regulation and reflect the
Authority’s ability to regulate the entire process
of pharmaceutical product assessment.
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6. Control of Drug Promotion &
Advertising
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Pharmaceutical manufacturers & suppliers
promote and/or advertise their products to
health professionals & the general public using
a number of methods.
– Advertising in journals or other media
– Direct mailings
– Personal selling through sales
representatives
– Provision of gifts and samples
– Sponsored symposiums and sponsored
publication of information materials
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6. Drug Promotion Control….
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Such promotion aims to influence people’s
attitudes, beliefs & behaviour and encourage
them to use a particular brand of product.
Drug information can significantly influence the
way drugs are used by consumers and
providers of medicines (prescribers and
dispensers).
Regulation of drug information and promotion
is therefore necessary to prevent the
dissemination of inaccurate and misleading
information.
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Challenges
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Evaluation & registration of drugs including
antibiotics in terms of the number of qualified
staff, available reference materials, data
management and processing of drug
applications
Licensing of premises taking into account
again human resources available, size of the
country
Inspection – availability of financial & human
resources & follow-ups after inspection
Quality testing – equipment, reagents,
analysts etc
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Challenges…..
• Post-marketing surveillance (PMS) – Collection
of samples, screening, analysis & results
dissemination. TFDA has recently prepared a
PMS programme which defines implementation
strategies for efficient & effective PMS.
• ADR monitoring – detecting, understanding, and
assessing ADRs and sharing of information with
the public
• Promotion control – follow-ups after approval or
rejection, control of banners, control of
misleading claims
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Challenges…..
• Control of antibiotic resistance:
– Enforcement or control of antibiotic
prescribing and dispensing practices including
limiting as “prescription only medicines (POM)
– Monitoring of antibiotic resistance including
dosage compliance and usage in food
producing animals
– Educating the public on the use of antibiotics
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Ahsante
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