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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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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FLAG AND EMBLEM OF KUWAIT COUNTRY

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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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•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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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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ORGANISATIONAL STRUCTURE OF KUFDA

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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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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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• 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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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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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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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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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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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. 15

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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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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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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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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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. 20

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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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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