Advice Pool - Reference and Education

China is one of the fastest developing countries in the world. It boasts a population of over 1.3 billion, and twenty one percent within that num

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

ber are children (Central Intelligence Agency [CIA], 2006). They witness disease, death, poverty, and much more on a daily basis. With such a lar

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

Examples of combination products may in

e percentage of the children in the world coming from China, people need to take the time to learn about their education, health care, family life

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

and other culture issues they face on a daily basis.

The health care involving the children in China continues to improve with each year. The a

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

nual number of births in 2004 was 17,372 and the number of children under the age of five that died was 539 in 2004 (United Nations International

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

Combination pro

Children’s Emergency Fund [UNICEF], 2006). “While child mortality rates in developed coastal areas approach those of industrialized countries, in

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

most Western provinces they are 3-5 times higher” (UNICEF). Pneumonia, asphyxia, premature birth, and low birth weight are cited as the main caus

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

s of neonatal deaths in China (UNICEF). The main cause of death in children ages one to fourteen is injury (UNICEF). One of the positive additio

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

s to the lower number of child deaths is the increase in the number of women that are choosing to breastfeed their babies. Breastfeeding goes han

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

d in hand with the nutritional status of the children in China. The nutrition of the children has greatly improved with more mothers now breastfe

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

ding and with supplementary food being introduced. Overall, today it is extremely rare to come across large cases of malnutrition.

A child’s edu

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

Following aspects would a

ation is a very important aspect of the Chinese culture. “Since the early 20th century, mathematics and natural sciences have been considered to

dd to the challenges in developing combination products:

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

e the most prestigious academic subjects” (Tsui, 2005). Because of the emphasis put on school, children are instilled with the drive to study and

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

work hard. “Parents encourage children to work hard by bragging and expressing their anxiety about their children’s school rank to neighbors and

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

olleagues, often in front of their children” (Tsui). In most Chinese cities, the students’ examination grades are put in order from best to worst

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

nd made known to everyone (Tsui). The ranking system puts a lot of pressure on students to excel in their classes in order to earn a higher ranki

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

Professional from academic institutions, pharmaceutical industries, health care indust

g with the next exam. The teachers use public correction and criticism as a means of correcting a child in the classroom (Vaughan, 1993). Teache

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

rs believe that using these methods “will help the child work harder so as to avoid future mistakes” (Vaughan). The public reprimand is often ref

.

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

rred to as a “loss of face”. “The importance of ‘face’ has a long history in Chinese culture…it is a reflection upon the whole family” (Vaughan).

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

Companies that provide selfless information through particip

If the child performed poorly, then it was seen as the responsibility of the parents or other family members that the child lived with at the time

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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Advice Pool - The Children of China – Part 1 of 2

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