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One might have hoped that China would have learned some lessons about pollution by watching America's expansion problems over the decades, but China's explosiv

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

e growth has brought its industrial pollution problem to a level that will require some drastic steps to fix. That's the bad news. The good news is that Chines

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

Examples of combination products may in

officials seem to be ready to take steps to reduce the country's pollution problems before they get totally out of hand.

The Pearl River

On

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

of the most promising clean-up projects is being undertaken on the Pearl River, which is China's equivalent of the Mighty Mississippi. The Pearl's headwaters

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

are in the Tibetan foothills, where the river begins its 1,375-mile journey to the South China Sea. Nearly a third of all Chinese goods designed for foreign ex

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

Combination pro

ort are manufactured along the Pearl, which means that the river has suffered a heavy toll over the years. However, the Chinese government has spent billions o

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

dollars to build new sewage treatment plants and to move heavy industry out of the country's major cities. Although there has been a marked improvement in the

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

river's water quality, there's still a long way to go before the Pearl will conform to Western standards or those of other prosperous Asian nations.

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

reenhouse Gases

China's growth explosion has some environmentalists predicting that the country may surpass America as the world's largest producer o

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

greenhouse gases within the next two decades. This is in large part to the rise in the standard of living of the average Chinese citizen, who can now afford t

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

buy an automobile for transportation. In fact, Chinese consumers are buying nearly 24,000 new cars every day.

Drinking Water

The Chinese go

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

Following aspects would a

vernment has been inundated by concerns from citizens about the quality of their drinking water and their farmland as industrial growth and mining continue to

dd to the challenges in developing combination products:

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

oom at an unprecedented rate. Government officials realize all too well that they must try to maintain some control over the explosive growth if they hope to r

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

main in power. The creation of an EPA-style agency, called the State Environmental Protection Agency (SEPA) was meant to be a step in that direction, but it ha

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

s so far had a spotty success record at best, because its real power is at the provincial level, and most Chinese provinces are more concerned with improving t

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

e living standard of their citizens than with environmental protection.

The Pearl River project will give China an opportunity to show the world their commitm

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

Professional from academic institutions, pharmaceutical industries, health care indust

nt to clean water, and water quality has improved over the past five years, but there's still a long way to go. For instance, a recent study found high levels

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

of toxic metals in the Pearl River estuary, including shrimp that contained sixteen times the recommended level of cadmium.

There are some other encouraging d

.

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

velopments beginning to take place, including a growing number of green groups that are being formed on China's college campuses. It's yet to be determined whe

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

Companies that provide selfless information through particip

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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