process of registration of pharmaceutical products in kuwait

1. KUWAIT
FACILITATED BY:
Dr. T.M.PRAMOD KUMAR
PROFESSOR& HOD
DEPT OF PHARMACEUTICS
JSSCP
MYSORE
BY
VINOD RAJ.K
1 st M.PHARM
REGULATORY AFFAIRS
JSSCP
MYSORE
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2. COUNTRY PROFILE
• Full Name :THE STATE OF KUWAIT
• Capital ;KUWAIT
• Area:17,818 Sq Kms (6,880 Sq Miles)
• Major Language: Arabic
• Monetary Unit : Kuwaiti Dinar
• ICH Climate Zone: Zone IV
• POPULATION:4.1 MILLIONS
• REGULATORY AUTHORITY OF KUWAIT
• State of Kuwait drug and food control administration
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3. FLAG AND EMBLEM OF KUWAIT COUNTRY
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4. Market Size: USD $ 374 million.
Only 20% of pharmaceutical products in
terms of volume were manufactured locally.
Market dominated by imported and
expensively priced patented drugs.
Kuwait has a strong pharmaceutical
regulatory structure.
Government taking measures to reduce costs
of essential drugs, which are considered the
highest in the Middle East.
KUWAIT PHARMACEUTICAL MARKET
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5. •Widespread prevalence of chronic diseases (see “High
Prevalence of Lifestyle-Related
Ailments” under Section 3), growing population, high per capita
income, and limited indigenous manufacturing capabilities have
presented a number of growth opportunities for multinational
and regional pharmaceutical companies. In line with the general
trend observed in the GCC,
•Kuwaiti population is also highly inclined towards branded
drugs.
The country’s pharmaceutical market was valued at US$ 781
million in 2012, having grown by 6.0% .
• Pharmaceutical sales per capita was broadly in line with the
GCC average.
•Kuwait’s pharmaceutical industry is half the size of the UAE
market.
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6. MAJOR PHARMA COMPANIES IN KUWAIT
The most prominent drug maker is the Kuwait Saudi
Pharmaceutical
Industries Company, which currently operates under a joint
venture between Kuwaiti and
Saudi partners,
•SANOFI AVENTIS
•YIACO PHARMACEUTICALS
•AL MOJIL DRUGS COMPANY
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7. ORGANISATIONAL STRUCTURE OF KUFDA
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8. Guidelines for registration of
pharmaceutical products.
Documents and materials required for registration and re-
registration of a Pharmaceutical company and its products
in accordance with ministerial decree.
Legalized must be done by the following:
I. Kuwait embassy/consulate in the country of origin and
when it is not possible, by an authorized Arabian
embassy/consulate in the country
II. Arab chamber of commerce of the country of origin.
III. Kuwait chamber of commerce.
•file should be submitted in CTD format according to ICH
guidelines.
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9. 1. Company registration:
• Legalized letter of appointment from company (Stating that the agent is
the sole exclusive agent in Kuwait.).
• Original legalized Manufacturing License from country of origin for
each manufacturing site issued from ministry of health in country of
origin.
•Original legalized “Good Manufacturing Practice” (GMP) from country
of origin. (Not older than 2 years)
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10. • Site master file must contain the following:
•. General information & history of the company including registered
•. capital & turnover for the past 3 years
•Layout and diagrams of manufacturing sites.
•. Quality control unit & quality management.
• Personnel information including number of employees in each department and
their qualifications.
• Premises & equipments which include manufacturing sites owned by company,
manufacturing lines, and equipments.
• List of products manufactured by the company and exporting countries.
•. Distribution problems, complaints, product defects and recalls from any authorities
worldwide.
•Contract manufacturing information
• FDA, EMEA, GCC or any recognized global approvals for the company
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11. 2. Product registration:
 Original legalized Certificate of pharmaceutical product
(CPP) for each pharmaceutical product in accordance with
World Health Organization (WHO) recommended format
issued from ministry of health in the country of origin.
 Original legalized Price certificate issued from the
country of origin, and showing the following:
 Ex-Factory price.
Whole sale price in the country of origin. Public price in the
country of origin. C & F unit price for Kuwait.
C & F unit price for the GCC countries and retail price in
UAE.
 Legalized declaration - for Innovators’ companies- of
patent expiry
date& patent no. of the innovator product from the country
of origin,
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12.  Certificate of composition, mentioning the active and inactive
ingredient (excipients , preservatives , coloring materials,
flavoring agents , etc.. ) with their quantities.
 Source of supply of all ingredients (active & inactive)
Raw materials specification (Pharmacopeia reference.)
Certificate of suitability for any ingredient from animal
origin (TSE/BSE certificate)
Alcohol content declaration
 Detailed Finished Product Specification and standards / (End of shelf
life, Finished product specification), laid down by the manufacturer, with
limits for the respective tests for each pharmaceutical product, together
with its method of analysis in details.
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13. Reference standard of the active ingredients and related substances
with certificate of analysis to be submitted with their specification in
full detail to be used as standard in the assay and identification. It
should be labeled by generic name and batch number, manufacturing
date, expiry date, storage conditions and chemical Potency
Quantities of samples of the product to be submitted with the
documents should be in their original packs and have the same
batch number to be registered should be made available to the
Pharmaceutical & Herbal Medicines Registration & Control
Administration.
o Certificate of analysis in full detail for the finished
product (for the same batch to be registered).
Batch manufacturing records to be submitted for the same
batch of the product to be registered.
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14. The pack label: should be printed with:
Name of the product.
 Name of the manufacturer and country of origin.
 Batch or lot number.
Manufacturing date.
Expiry date.
 Storage conditions.
Name of the Pharmacopeia (for the Pharmacopoeial product).
Above information on stickers is not approved / allowed.
All information on sample label, container and package insert
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15. Leaflet should include the following information:
 Enclosed leaflet must be in readable text size, understandable
language (English or English/Arabic)
Description; product name, strength, dosage form, active
substance, list of excipients, warning about certain excipient
such as lactose.
Indication, use and Clinical pharmacology.
 Dosage and method of administration.( may illustrated with
pictograms and symbols)
Warnings and precaution.( boxed warnings maybe added at the
top of leaflet)
Contraindications.
Use in specific populations.
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16.  Adverse reactions.
Over dosage.
Drug interaction /Laboratory test interaction.
 Drug abuse /dependence.
Non clinical toxicology.
 Clinical studies.
 How supplies /storage and handling.
Name &address of marketing authorization holder.
Date of last revision
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17. Stability studies as per ICH guidelines for climatic zone III
& IIV
 Batch Type and Size:
Stability studies should be provided for three batches of the
same formulation and dosage form in the container closure
system proposed for marketing.
Two of the three batches should be at least pilot scale (1), the
third batch may be smaller.
• Batch type and size should be mentioned in stability study
protocol.
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18. Raw data of the study must be in
tabulated form.
 Study conditions:
o General case / non specific studies:
 Studies for products stored in
refrigerator
Studies for products stored in
impermeable containers
Studies for products stored in semi
permeable containers
 Studies for products stored in freezer
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19. Stability study protocol and conclusion.
 Product shelf life and storage conditions should be in
conclusion of stability study.
Testing frequency :
 Every 3 months the first year , every 6 months the second
year and then annual
 Bracketing (4) can be applied to studies of the same
container closure system where strength, container size or fill
varies while the other remains constant.
Stability studies for utilization period (in-use period) for
preparations in multi-dose containers should be submitted.
Effect of light (If applicable )
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20. Pharmacological, toxicological, clinical & non clinical studies and
reports of the product, with published papers from international
journals as to the safety and clinical efficacy of the product.
A signed commitment to provide Kuwait food and control with a
post marketing surveillance reports and any safety reports or ADRs
report which the company may receive from users or healthcare
professionals.
Pharmaceutically equivalent multi –source pharmaceutical product
(generic) needs to conform the same standards of quality, efficacy and
safety of the originator, several test methods are available to
therapeutic equivalence:
Bioequivalence studies in Humans.
 Comparative Pharmaco-dynamic studies in Humans.
Comparative Clinical studies.
 In-vitro dissolution studies.
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21.  Biosimiler products require additional documents,
Any change in the name of the manufacturer,
product, shape of pack, specifications, shelf life,
composition or leaflet of the product should be
handled with logical reasons or scientific
explanations. For detailed types of changes and
required documents,
All the ministerial decree regulations for the
registration, release and inspection of human
pharmaceutical products is applicable for the
registration of veterinary pharmaceutical product.
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22. REFERENCES:
•http://www.moh.gov.kw/kdfc/index_en.
htm
•http://www.alpencapital.com/downloads
/GCC%20Pharmaceuticals%20Industry%20R
eport%202013_31%20March%202013.pdf
•http://www.goic.org.qa/FCMP/website/
documents/presentations/Dr.%20Aassim%2
0Qureshi%20-
%20Director%20QNB%20Capital.pdf
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