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Digg It - China Requires AQSIQ Registration for Import of Waste Materials!
China last year became the first country ever to import more than $1 billion of American scrap, ac
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
cording to the newspaper American Metal Market. The demand is so high that most scrap suppliers th
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
t sell to China are looking everywhere to grab up any materials available. Copper scrap exports to
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
China, including Hong Kong, have quintupled since 1998, and China now accounts for 70 percent of t
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
e total. China's purchases of American copper scrap last year were equal to about 40 percent of Am
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
rican consumption. –New York Times
On of the biggest hurdles to selling scrap to China is the AQS
On of the biggest hurdles to selling scrap to China is the AQS
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
Q registration requirements. China’s General Administration of Quality Supervision, Inspection and
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
Quarantine (AQSIQ) Office requires all importers of scrap material to be registered.
The process
The process
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s extremely time consuming, difficult, and costly. There is also the overall high rate of failure.
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
All materials must be in Chinese and there is no support or assistance for non-Chinese speaking ap
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
licants. Many law firms will offer their assistance in translation and applying for AQSIQ registra
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
tion but they lack the ISO experience to understand the requirements required from the AQSIQ offic
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
s and how to make sure they are satisfied. So even though the market is there and the demand is th
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
highest it has ever been, some companies still find themselves unable to profit from the growing
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
crap market in China.
Agencies are available to assist companies who wish to submit their applica
Agencies are available to assist companies who wish to submit their applica
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
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
ion for registration with AQSIQ offices. One company, ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
">Ejoy Quality Source USA, has an office in the USA and an office in China with certified Chin
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
se ISO inspectors who can work with you to not only translate the required documents but suggest w
.
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
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
ys to satisfy the strict requirements for approval of registration.
For a quick breakdown of the
For a quick breakdown of the
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
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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