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    ECONOMY. Malaysia is a middle-income economy and has the third highest GDP per capita (US$4,625) among the Southeast Asian countries after Singapore and Brunei. The country was primarily a producer of raw materials but transformed its economy from the 1970s to the 1990s into a
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    multi-sector economy. Malaysia's economic growth is export driven mainly from exports of electrical and electronic products.

    Malaysia's economy is relatively stable with healthy foreign exchange reserves and a GDP of US$118.3 billion in 2004. From 2000 to 2004, Malaysia's real
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    GDP grew by an annual average of 5.7% while inflation remained below 2.0% and unemployment below 4.0%. The Asian economic crisis of 1997 adversely affected Malaysia's economy during the period. It is unlikely that the country will experience an economic crisis similar to 1997 w
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    th current healthy foreign exchange reserves, low inflation and small foreign debt.

    The manufacturing sector accounted for 48.5% of Malaysia's GDP in 2004, services accounted for 42.4% and the agriculture sector accounted for 9.1%. Major industries include electronic & electri
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    al products, textiles, clothing & footwear, chemicals, petroleum, wood and metal products. Major agriculture industries include palm oil, rubber, cocoa, rice, poultry and timber.

    DEMOGRAPHY. Malaysia comprises of Peninsular Malaysia and East Malaysia (located on the northern h
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    lf of the island of Borneo) with a population of 26 million. Malaysia is a multi-ethnic society comprising of the predominant indigenous Malays (50%) followed by the Chinese (24%) and Indians (7%). Other indigenous groups (11%) include the Ibans, Kadazans, Melanaus and Kelabits
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    . Major religion practiced is Islam followed by Buddhism, Taoism, Hinduism and Christianity. Major languages used are Malay (national language), English (commonly used in business), Chinese (mainly Mandarin, Hokkien and Cantonese) and Tamil.

    Malaysia's population is becoming i
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    creasingly urban. The country's urban population increased from 54.7% to 62.8% of Malaysia's total population from 1995 to 2004. Main reason is increasing employment opportunities in the major urban areas. Major urban areas include the nation's capital Kuala Lumpur and the surr
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    unding areas (known as the Klang Valley), Penang, Johor Bahru, Ipoh, Kuantan, Kuching and Kota Kinabalu.

    Households in the urban areas have an average income that is twice than those in the rural areas. An estimated 5% of Malaysian households live below the poverty level while
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    50% are low-income households. The proportion of medium income households is 33% while high-income households are 10%.

    INFRASTRUCTURE. Malaysia has a well-served international and domestic telecommunication system. Cities and towns are well connected by roads including highway
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    and public transport. Internet broadband services are available in the cities and major towns. Malaysia has an international airport situated near Kuala Lumpur and airports across the country serving mainly domestic travel.

    INTERNATIONAL TRADE. Malaysia's major trading partne
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    rs include the United States, Japan, China, Singapore, Thailand, Taiwan and South Korea. Major exports from the country include electrical and electronic products, machineries, petroleum and liquefied natural gas (LNG), textiles, clothing & footwear, palm oil, furniture and saw
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    timber. High technology exports (mainly electrical and electronic products) account for more than 50% of Malaysia's exports. Major imports include electrical and electronics, machineries and equipments, petroleum products, plastics, iron and steel products, chemicals and foods
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin


    CONSUMER USAGE OF TECHNOLOGY. Nearly 75% of all homes have fixed line telephones and there are 15 million mobile phone subscribers for a population of nearly 26 million in 2004. Penetration of personal computers in homes was nearly 30% during the period with 3.5 million inter
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    et subscribers and 10 million internet users. More than 90% of all Malaysian homes have refrigerators and televisions. Nearly all middle and high-income homes have cars and most have more than one. The estimated penetration of cars in homes is between 75% and 80%. Thus, many lo
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    -income homes have cars but tend to be lower-end models or cheaper second hand cars. Furthermore, nearly all lower income homes have motorcycles for their travelling needs.

    RETAIL MARKET. Retail sales in Malaysia reached an estimated US$14 billion in 2004 and forecast to grow
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    further to US$20 billion by 2010. The Klang Valley (Kuala Lumpur and the surrounding areas) contributes nearly 30% of the country’s total retail trade. The traditional "mom and pop" establishments dominate Malaysia’s retail industry while shopping at the modern retail establish
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ents such as hypermarkets, supermarkets, departments, mini-markets and convenience stores is gaining popularity. These modern establishments account for nearly 25% of the total retail sales. Shopping at the traditional open-air markets remains popular among Malaysia’s low, medi
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    m and even high-income consumers because of their festivity atmosphere.

    FOOD CULTURE. Malaysia has three major ethnic food cultures i.e. Malay, Chinese and Indian foods. Rice is the staple food followed by various types of noodles and Indian bread. Malay dishes tend to be hot
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    nd spicy, Indian foods are usually curry dishes while Chinese foods are salty. However, the various ethnic communities have adapted foods from other communities. Western baked bread and bakeries and fast foods are popular and affordable even among many in the lower income group


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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