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China Regulatory Affairs: Imported Drug

Key stakeholders, value chain analysis, SFDA requirements, timeline & costs

Report Overview

It is predicted that China will become the world’s second largest pharmaceutical market by 2015 due to robust economic growth and healthcare reforms that allow for increased spending on drugs. In China, imported drugs enjoy a higher reputation for quality. Foreign pharmaceutical manufacturers have an opportunity to take advantage of this perceived brand value to build a presence in this huge market.


For imported drug to be sold in China, it must be registered with and have its label approved by the SFDA. For foreign pharmaceutical manufactures it is of key importance to understand the SFDA requirements and how with up-to-date information their products can reach the market.


This report starts with the introduction of drug definition(s) in China, the classifications of drug defined by the SFDA as responsible authority for the registration. It also presents the key stakeholders, value chain analysis, timetable, costs and required documents for the imported drug clinical trial approval and registration. This report will be helpful for companies wishing to bring successfully imported drug brands to the China market.


Key Report Features

Definition of drug in China
Regulation and responsible authority for drug registration
Classifications of drug
Key stakeholders and value chain analysis for imported drug clinical trial approval and registration
Imported drug clinical trial approval and registration process
Imported drug clinical trial approval and registration timetable and costs
Required documents for imported drug registration
Clinical trials requirements for drug registration

The report contains 25 pages in presentation format.


Who Would Benefit From This Report?

Regulatory affairs director/manager
Business development director/manager
Chief marketing officer
Marketing director responsible for the business
Other players in the Medical Device industry
Researcher and financial analyst in the pharmaceutical industry
Private and institutional investors in the pharmaceutical industry

Publication date

September 3, 2012


Price

5,000 RMB / 800 USD for Chinese / English report

*You can send E-mailEmail to LFE to purchase this report.


Please transfer the RMB or USD payments to the following account:

 

A/C: Shanghai Loudon Marketing Consultant Co., Ltd
A/C: No. 444259223258
Bank Name: Bank of China Shanghai, FanYu Road Sub-branch
Swift code: BKCHCNBJ300

 

Name Beneficiary：Loudon Far East B.V. The Netherlands
Bank Name：ING Bank N.V.
Account No：67.38.48.906
IBAN：NL23INGB 0673848906
BIC/SWIFT：INGBNL2A

 

 

 



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