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Main Subject - Documentation for Representative Offices in China
An application letter signed by the foreign head office’s
Chairman of the Board or General Manager requesting per
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
mission
to establish a Representative Office must be prepared and must
include the proposed Representative Offic
; 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
’s proposed name,
purpose, scope of business, duration, and the term of office of
the Chief Representative. It m
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ust also include the historical
background of the head office, the names of the General
Manager, the Chairman of
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
the Board, and the other directors of
the head office, the names of the head office’s primary trading
partners i
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
China, and its business volume.
Supporting documents include (but are not necessarily limited to):
A completed
Supporting documents include (but are not necessarily limited to):
A completed
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
SAIC application form
The foreign head office’s incorporation documents, including certified copies of the Cert
The foreign head office’s incorporation documents, including certified copies of the Cert
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
ficate of Incorporation, business
registration certificate, Articles of Incorporation (or
equivalent), etc.
An
An
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
original of a letter from the head office’s bank attesting
to the head office’s financial standing (amount on dep
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
sit and
other details pertinent to the company’s financial reputation)
A letter appointing the Representative Of
A letter appointing the Representative Of
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ice’s Chief
Representative and any other representatives, along with their
resumes and copies of their IDs (pass
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
ports for non-Chinese
nationals) and photos
Copies of the lease agreement for the Representative Office’s offic
Copies of the lease agreement for the Representative Office’s 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
premises from an approved unit (such as a commercial
building or hotel)
Permit use certificate (required in som
Permit use certificate (required in som
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
e jurisdictions), to be
completed and signed by the landlord and tenant
An “Approval Certificate for Premises to
An “Approval Certificate for Premises to
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
be Occupied by a
Foreign Company” (required in some jurisdictions)
Other possible documentary requirements inclu
Other possible documentary requirements inclu
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
e:
(1) Board resolutions authorizing the establishment of the Representative Office and appointing the Chief Rep
(1) Board resolutions authorizing the establishment of the Representative Office and appointing the Chief Rep
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
resentative;
(2) Proof of more than US$10,000 in paid-in capital;
(3) Certification in both English and Chinese
(2) Proof of more than US$10,000 in paid-in capital;
(3) Certification in both English and Chinese
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
f the head
office’s Articles of Incorporation (or equivalent), and tax
registration certificate.
All of the for
All of the for
.
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
egoing documentation should be prepared in both
Chinese and English. Please note that certain jurisdictions
requ
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
re additional documentation and that industry-specific
requirements apply in certain industries (such as finance)
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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