Main Subject - Business

Picture Beijing in the early 1990’s – a strong visual presence of communism in the typical courtyard-style housing (12 families housed in a block built around a central ya

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

rd), grey Mao suits everywhere, almost no neon advertising signs and only occasional cars and mini-vans on the streets. In those days there were two currencies: Yuan and F

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

Examples of combination products may in

C(Foreign Exchange Currency) available only to foreigners, with a lower exchange rate than Yuan (1$=8.9yuan, 1$=7.4FEC). Strong government control, exacerbated by the rece

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

nt happenings on Tiananmen Square, meant that getting to know Chinese people was almost impossible - they were not allowed to enter hotels and so had no exposure to foreig

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

goods and lifestyle, which were only available in hotels.

The mid-90’s brought new perspectives and possibilities to China. Private ownership was booming, bringing chang

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

Combination pro

es in life style and rapid expansion overnight in the car industry, service industries, street advertising and real estate. A foreigner wanting to take advantage of the nu

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

erous opportunities of setting up a private business in China came up against a mountain of obstacles presented by Chinese law. The only way a foreigner was permitted to s

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

tart a business was in partnership with a local person, who would have to have a major share of ownership and all legal rights. In order to apply, the name approval, accep

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

ance from MOFTEC (the Ministry of Foreign Trade and Cooperation) and tons of other paperwork all had to be legally registered, which would take many months and was often d

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

ependant on how good guanxi (relationship building) your Chinese partner had with local authorities.

The beginning of the 21st Century brought further developments. The p

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

eviously tedious business registration process could now be done by various consulting agencies, providing this service for a minimum sum in a much shorter time. The easie

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

Following aspects would a

t way of setting up a company was to apply as a consultancy service, which term covered such a broad spectrum that it effectively allowed the individual to explore busines

dd to the challenges in developing combination products:

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

s opportunities according to the market growth. Three options became available:
- Full Chinese ownership for the investment of 100,000 yuan
- Joint venture with

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

1-49% ratio in favor of the Chinese partner for the same amount.
- Full foreign ownership (WOFE – Wholly Owned Foreign Enterprise) for $100,000
At this period Ch

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

ina was still looking at limiting market growth to businesses with ‘serious’ investment, although services for setting up ones own business were much improved and once the

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

business was up and running the only further legal obligation was to pay taxes.

The year 2005 brought in yet more changes and China continues to relax its need for contro

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

Professional from academic institutions, pharmaceutical industries, health care indust

l. Setting up a consulting company now takes only a few months. With a small amount of paperwork and a minimum of $10,000, you can own the business in China, as long as it

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

is already registered abroad, with a Hong Kong bank account. The second step would be to hire an accountant (part-time if necessary) and open a mainland China bank account

.

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

. For office space, you can run your business from home as long as the real estate management has a licence for such services or if you own the apartment. So, these days y

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

Companies that provide selfless information through particip

u are pretty much free to find your own way, use your own guanxi and explore the many opportunities in the land of dragons.

Copyright 2006 Dalida Turkovic

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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