U.S.-China Trade: Summary of 2003 World Trade Organization Transitional Review Mechanism for China Page: 83 of 101
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Summary of issues by theme Raised by Raised by China's response
United States other WTO
confidentiality of such data pursuant
to TRIPS; statistical or other
information regarding implementation
of data requirement.
Explanation of whether and how the
data exclusivity provisions provided
by the State Food and Drug
Administration (SFDA) implement
requirement to protect undisclosed
data pertaining to pharmaceutical
products submitted to government
authorities for marketing approval
from unfair commercial use.
SFDA's protection of data submitted Writtena
when marketing approval for such
data is thereafter denied.
SFDA's creation of of an obligation of Writtena
competing drug companies not to
obtain or exploit protected data,
including the right of an injured party
to sue for theft of this information.
SFDA's establishment of an obligation Writtena
not to use such data for any purpose
other than the marketing approval of
SFDA's definition of confidential data Writtena
intended to provide the same private
rights for protection of this
undisclosed information as those
provided by the Law to Counter Unfair
Procedures to protect confidential
information in intellectual property
To date, the State Food and Drug
Administration (SFDA) had not found any
application for drug registration which used
undisclosed information. In regard to data
exclusivity provided by the SFDA, the Chinese
representative referred to the relevant
regulations. Pursuant to Article 35.2 of the
Rules on Implementation of Drug Law, the
SFDA would not render a marketing approval
pursuant to an application by taking advantage
of other applicants' undisclosed information.
Pursuant to Article 14 of the Measures on
Regulation of Drug Registration, when putting
forward an application for drug registration, the
applicant should ensure that all data submitted
were obtained independently. Pursuant to
Article 21 of the Measures on Regulation of
Drug Registration, when putting forward an
application for drug registration with foreign
data being introduced, the applicant should
provide the verification of the legal origin of
data. Pursuant to Article 22 of the Measures
on Regulation of Drug Registration, the SFDA
was entitled to require applicants to repeat the
test in order to ensure that the relevant data
had been obtained independently. Pursuant to
Article 52, during the period of new drug
approval, the technical requirements upon a
new drug would not be lowered because the
drug of the same class had received a
marketing approval abroad, that is to say, the
situation of documentation dependence did not
exist. Pursuant to Article 35.2 of the Rules on
Implementation of Drug Law, the SFDA would
not render marketing approval to an application
taking advantage of other applicants'
undisclosed information. The SFDA had the
obligation to protect the undisclosed test data
obtained independently and other relevant data
submitted by the applicant. Those illegally
disclosing undisclosed data would be
punished. The SFDA would accept a relevant
application in accordance with Article 35.3 of
the Rules on Implementation of Drug Law
under the condition that measures had been
taken, as the public interest required, to protect
the data against unfair commercial use.
Besides Article 120 of the Civil Procedure Law
and Article 48 of the Provisions Regarding
Evidence in Civil Litigations, the other
provisions of the Civil Procedural Law and
other laws, such as the Law on Lawyers and
the Law for Promotion of Science provided
protection for confidential information during
civil litigation. (Verbale)
GAO-05-209R U.S.-China Trade
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United States. Government Accountability Office. U.S.-China Trade: Summary of 2003 World Trade Organization Transitional Review Mechanism for China, text, January 25, 2005; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc301428/m1/83/: accessed May 27, 2019), University of North Texas Libraries, Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.