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  • Main Subject - Regulations and Operating Environment in China

    Overview

    Retailing has been named a strategic industry in China’s long term national plan. As mentioned in repo
    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
    rt 1, the opening of China has caused more foreign retail chains to enter the China market. As more foreign comp
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    anies enter the China market, the Chinese government has come up with changes to regulations in the retail and f
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ashion industries in recent years. In this report we would talk about the updated regulations and a little on th
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    e operating environment for clothing companies in China

    Regulations

    a) The most important changes to the Retai
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    l regulations introduced by the Chinese government (MOFCOM) is the clause on franchising. b) With effect from
    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
    1st February 2005, foreign retail chains who want to offer franchises directly to prospective franchisees in Chi
    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
    na must first established 2 company owned unit in China for more than a year. The reason given by the government
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    for the introduction of this regulation is to protect Chinese companies from buying franchises whose models are
    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
    not suitable for the Chinese market. c) Franchising in China is complicated process. Foreign firms who want t
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    o enter the countries though franchising has to fill in another set of franchise forms and undergo another busin
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ess registration form. This application would usually take about....

    Impact:

     The impact of this franc
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    hise regulation is that foreign owned retail chains including Foreign Fashion Chains would find the process of e
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ntering the country by franchising more tedious. This is especially for mid sized retail chains who are establis
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    hed in their home countries and are not international brands. Thus for small to mid sized foreign fashion firms
    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
    wanting to enter China through franchising, we would suggest other marketing strategies like Distribution, setti
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ng up their own flagship store and

     One Alternative would be to enter by Joint Venture agreement or par
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    tnership with a China local firm. This could be done either through partnership with local firms or buying into
    .

    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
    local manufacturing companies.

     Another market entry strategy ....

    Article by China based consultants
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    in O&L Consultancy Services Pte Ltd. To read more on regulations please email us at oandltraining@pacific.net.s


    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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