Advice You - Business

The world today has been benefiting from years of research in technology. With just a click of a button, one can get just about any information instantly. Under this rapid pace, businesses around t

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

he world are demanding faster increase in sales and efficiency. Nowadays the phrase “doing business” means more that just a profit-making activity for livelihood. Companies in every country are loo

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

king for ways to become a global brand and investing in various markets. When China opened up its market few decades ago, foreign investors swept in and saturated the China market. Since then, Chin

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

a’s economy has been escalating not only financially but socially as well. According to Embassy of the People’s Republic of China in the United States of America, China's GDP has reached US$ 2.23 t

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

rillion in 2006 which is ranked fourth in the world. Today, China has transformed into the world’s factory.

China may seem to be a huge potential gateway for foreign investors but the China market

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

is not like any other market. With its long history and rich heritage, China has a distinctive culture which many foreigners are unable to comprehend. Plunging into a market without knowing its pr

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

actice and procedures is just like walking right into the lion’s den. Many have lost billions when entering the Chinese market despite their long haul of experiences. To make it big in China, forei

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

gners are unable to survive just with their experiences. The complexities on how the Chinese carry out their business poses a huge barrier for foreign investors.

1. Language barrier

Even though E

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

nglish is the international language, the majority of the Chinese populations do not have the full grasp of it. Hence, to be able to communicate effectively in China, one must be able to speak and

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

understand the Chinese language. As China is the only country which uses the Chinese language, not many foreign investors would be able to communicate with any Chinese organizations, distributors o

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

supplies. Thus, the language barrier between the Chinese and foreign investors have been a major issue for years. In most cases, foreign companies source for translators and middlemen before enter

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ing the China market.

2. Network building (Guan Xi)

The Mandarin term “Guan Xi” (pronounced as ge-wan-si) means having relationships. The Chinese believes that to be successful, one must have goo

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

d relationship with others. Establishing good relationship means building up a close network with the government, other organizations and within your own organization. In the business industry as w

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

e meet and negotiate with people all the time, the Chinese believes having close relationships with others would be the way to get things especially when investments in China would be under the adm

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

inistration of the China government.

It would be a huge risk to try to enter into China market without having any “Guan Xi” with anyone. Firstly, there will be so many problems with the government

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

and other organizations as foreign investors do not understand the China practices. In addition, they would not know how to handle these problems. Thus, it is imperative to either have a network i

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

n China or to find a way to start developing “Guan Xi” in China.

Before embarking on a China investment plan, it is necessary to conduct a detailed market research. It would be recommended to have

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

an individual or an organization that is familiar with the bureaucratic procedures and Chinese culture to aid the company. This would allow a more fruitful negotiation with suppliers and distribut

.

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

ors and a smoother administrative process.

The China market is really a window of opportunities but for foreign investors, every decision made with respect to china market entry is vital to the co

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

mpany’s future. All investments have their own fair share of risks but issues like language barriers and different business methods; can create much complexities and problems for foreign companies

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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