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We often get people asking us "How can I claim tax back" or "Can

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

I get a tax refund" and whenever we secure the refund our clien

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

Examples of combination products may in

s are always very happy, as you would maybe suspect. Recently

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

we have begun to look at things from a different perspective. We

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

should not be unhappy to receive a tax refund and if we ever owe

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

Combination pro

money to the Inland Revenue we should be happy. The reason behin

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

d this thinking is that if we are due a tax refund it means that

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

we have unnecessarily paid tax throughout the year and have effe

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

ctively given the government a interest free loan for 12 months.

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

Imagine if you are given a tax rebate of one thousand pounds. I

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

this one thousands pounds was put into an instant access saving

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

Following aspects would a

s account for year at 5% it would have returned a gross amount o

dd to the challenges in developing combination products:

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

50 pounds. Therefore the cost to us of having the tax refund is

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

50 pounds.

Let me put it another way, how would you feel about

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

this: You give me 100 pounds out of your wages each month, and i

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

n a years time I will give you one thousands two hundred pounds.

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

Professional from academic institutions, pharmaceutical industries, health care indust

It doesn't sound as attractive now does it?

The opposite is als

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

true, we should be happy when we owe the government tax, it mea

.

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

ns that they have given us an interest free loan. This thinking

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

Companies that provide selfless information through particip

ight help put a sugar coating on any tax payments you might have

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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