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Despite the unexplainable bitter World War II has far-long ended, its negative effects are still prevalent, if I am not wrong, to

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

a very few world states. To be precise, China and Japan are probably the two most obsessive with the abuses and legacies of the

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

Examples of combination products may in

war.

The two Asian powers do possess two completely different visions, resulted from the World War II: China detests World-War-I

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

I Japanese soldiers, who disgustingly abused China and the Chinese; especially taking Chinese girls and women as comfort ladies.

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

On the contrary, Japan is of the opinion that their World War II soldiers are their great heroes and so worth be subject to annua

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

Combination pro

l homage. It has now come to the point that the Chinese always bitterly protest against annual pilgrimage of the Japanese prime m

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

inisters for paying homage to his World War II ancestors. Whose action is wrong?

Firstly, from the international aspect, the 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

nese is interfering into Japanese sovereignty. There are no any international laws or provisions that prohibit the leader of one

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

country from respecting his/her ancestors or heroes. Japan and China has not entered into any agreement that each country’s leade

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

rs should not pay homage to one’s ancestors at all.

The Japanese prime minister or the Japanese as the whole is not wrong in bei

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

g grateful to their ancestors. The bad deeds of the Japanese ancestors would not deprive them of ancestor-ship. The Japanese neve

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

Following aspects would a

r care about what their ancestors did in the past, but they just pay homage to them in the present time. Japan and China has the

dd to the challenges in developing combination products:

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

very similar culture in being close to one’s family; consequently you should understand and forgive each other in this respect.

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

Secondly, history is history, individual Japanese is not all the Japanese. China should think that only the World War II Japanese

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

soldiers that were wrong, but not the present Japanese. One bad Japanese does not mean all the Japanese are bad.

Finally, if Ja

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

panese be not allowed to pay homage to their heroes or ancestors, then the world should follow: America and UK should stop paying

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

Professional from academic institutions, pharmaceutical industries, health care indust

homage to their soldiers, who killed civilian Iraqis. The same story should be applied to every country of the world, not just J

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

apan alone.

In my last word, I even endorse Japan not to say sorry to the world about the atrocity that its soldiers committed 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

uring the World War II. The ones who did wrong were the World-War-II Japanese soldiers, so it would be them to say sorry, not the

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

Companies that provide selfless information through particip

present Japanese. And if the present Japanese are obligated to say sorry to China or the world; then everyone should do the same

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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