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The United States government criticizes China to resolve its rapidly growing trade deficit.

Deputy US Trade Representative

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

Karan Bhatia said that their rival country can receive penalizing trade measures from the US government if they do not open

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

Examples of combination products may in

up their market to American companies and if they do not treat US firms fairly. However, Bhatia did not imply that the US go

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

vernment would limit China's access to their market.

On the other hand, US Trade Representative Rob Portman has a different

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

take on United States-China trade situation. Last week, he expressed that the US government will set up a task force that w

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

Combination pro

ill monitor China's compliance with global trade policies. These policies focuses on implementing of intellectual property r

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

ights, easing up local industries, and carrying out vows to open the market to US companies.

According to Karan Bhatia, 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 has very much profited from their access to the US market, yet China is not doing their share as they continue in not giv

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

ing US companies a level playing field in their markets. Furthermore, as said by some critics, low-priced Chinese products h

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

as already flooded the United States, which resulted in financial struggles of US competitors and job insecurity in the indu

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

strial parts of the country. The Chinese government is also reported to keep the yuan currency weak in order to increase the

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

Following aspects would a

ir exports.

Last year, the trade deficit went to a record low of $725bn (?414bn) because oil prices rose and demand for imp

dd to the challenges in developing combination products:

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

orts of every kind increased.

In order to pacify US citizens who might lose their jobs because of the trade deficit, US leg

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

islators have proposed laws to lower trade relations with China. The US government also gave stern warnings to China to reva

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

lue its currency, and impose tariffs on Chinese products that is already flooding the country.

Analysts say that United Sta

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

tes government has limited options and they could not afford to get even with China because these actions could backfire at

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

Professional from academic institutions, pharmaceutical industries, health care indust

them.

In response to United States' stern warnings and criticisms, Chinese Foreign Ministry Spokesman Qin Gang expressed th

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

at the US plan to impose penalizing trade measures on them will not help ease their trade relations. He also said that such

.

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

impositions will not also be favorable to the business interests of the United States.

At the moment, people are anticipati

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

Companies that provide selfless information through particip

ng a resolution to this problem when Chinese President Hu Jintao visits Washington for talks with the US President in April.

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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