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    The Lunar New Year dates from 2600 BC, when Emperor Huang Ti introduced the first cycle of the Chinese zodiac.

    Because of cyclical lunar dating,
    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
    the first day of the year can fall anywhere between late January and the middle of February. On the Chinese calendar, 2007 is Lunar Year 4704-4705. On the Wester
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    calendar, the start of the New Year falls on February 18, 2007 - The Year of the Pig.

    The Year Of The Pig is of particular importance for North American real es
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    tate markets, since the level of interest rates is in direct function of how China's Central Bank will direct the investment of its USD 1 trillion in foreign exch
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    nge reserves.

    China's foreign exchange reserves are at twice their level of two years ago and amount to more than one-fifth of all global foreign exchange reserv
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    es in American Dollars. To put things into perspective, this humungous amount would be enough to buy all the gold sitting in the vaults of all central banks or, p
    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
    t differently, it would be almost enough to buy all residential property in the London Metropolitan Area. This massive hoard of foreign cash reserves is growing e
    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
    xponentially to the tune of some USD 20 billion per month.

    China's foreign exchange reserves already far exceed the minimum level required to ensure financial st
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    bility. As a rule of thumb, a country needs enough foreign exchange to cover three months of imports. The reserves of the People's Republic are already enough to
    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
    cover five times as much - 15 months worth of imports. This is the direct and proximate result of the country's large current account surplus, significant foreign
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    investments and big inflows of speculative capital, especially over the past couple of years. In theory, strong flows of foreign capital into China should have pu
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    hed up the Yuan to astronomical levels, but Beijing has resisted this by refusing to allow its currency to float freely, thus forcing the central bank to buy up t
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    he surplus foreign currency.

    How this stack of money is invested has big implications for the world economy, not just for China. But no place is more dependent o
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    the decisions that the Central bank will make in the Year Of The Pig than North America. This is so because approximately seventy percent of the country's foreig
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    n reserves are invested in American Dollars, mainly in US Treasury securities. This has propped up the Dollar and reduced American bond yields by as much as 1.5 p
    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
    rcent.

    China's central bank, however, has now signalled its intention to switch from Treasury bonds to American mortgage-backed securities and corporate bonds in
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    an attempt to earn higher yields. What's even more important, Chinese officials are also debating the need to diversify reserves out of American Dollars in order
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    to reduce the exposure of a big drop in the value of the Greenback, and to invest a larger slice into Euros and the emerging Asian currencies.

    Clearly, a big shi
    .

    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
    ft out of the Dollar could therefore push up bond yields and hence mortgage rates, thus damaging further the already weakened North-American housing markets. And
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    his is the reason why the Year Of The Pig promises to be a pivotal year and of great repercussions here in North America.

    Luigi Frascati

    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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