Measures on the Examination and Approval of Drug Advertisements - 1995
      (With the approval of the State Administration for Industry and Commerce
      and the Ministry of Public Health, the Measures on Examination and
      Approval of Drug Advertisements are promulgated and take effect on March
      22, 1995)

      Article 1
      These measures are formulated in accordance with the Advertisement Law of
      the People's Republic of China and the Drug Management Law of the People's
      Republic of China.

      Article 2
      All drug advertisements produced in whatever forms or published on
      whatever media, including the publication of leaflets by either drug
      producers or sellers, shall be subject to the examination and approval by
      relevant drug administrative authorities, according to these Measures.

      Article 3
      The examination and approval of drug advertisements are based upon the
      following laws and regulations:

      1) The Advertisement Law of the People's Republic of China

      2) The Drug Management Law of the People's Republic of China.

      3) The State's relevant regulations on advertising administration and the
      examination standards of advertising supervision departments.

      Article 4
      The State public health administration and medical administrations at the
      provincial, (autonomous) regional, and municipal levels (hereinafter
      referred to as provincial-level public health supervision departments) are
      responsible for the examining and approving drug advertisements, under the
      guidance of the advertisements supervision departments at the same level.

      The examining and approving department of drug advertisements is
      responsible for making suggestions to the supervision department in
      dealing with unlawful drug advertisements.

      Article 5
      Advertisements of newly-developed drugs or overseas-produced drugs and
      those advertisements to be published on the major media can only be
      released after they have been examined and approved by the State Council
      public health administrative department and been given an approval
      certificate.

      Other drug advertisements should be examined and approved by the
      provincial-level public health administrative departments of the place of
      drug production. Advertisers, who wish to publish drug advertisements in
      other localities, shall bring the drug examination and approval
      certificate, as issued by the public health department of the place of
      production, to the new advertising-targeted locality to exchange for their
      approval document.

      Article 6
      Advertisers shall submit drug advertising applications to drug
      advertisements examination and approval departments, file the drug
      advertisement examination and approval form, and submit the following
      supporting documents:

      1) A duplicate copy of the business license held by the advertisement
      applicant and by the drug producer;

      2) A duplicate copy of the official permit of drug producing enterprise,
      or the official permit of drug dealer;

      3) The official permit for drug production, the standards of drug quality,
      specifications and packaging

      4) Trade mark registration document of drugs, or other documents issued to
      prove the drugs' registration status by the Trade Mark Department under
      the State Administration of Industry and Trade;

      5) The examination and approval document issued by the State Council
      public health administrative department for drugs bearing specific trade
      names;

      6) Other certificates as required by laws and regulations to prove the
      authenticity of the advertisements' content.

      Article 7
      Advertisers, applying for publication of drug advertisements abroad, shall
      submit application to the State Council public health administrative
      department, file the drug advertisement examination form, along with the
      following documents and their Chinese translations:

      1) A duplicate copy of the business license of the advertisement applicant
      as well as the drug producer;

      2) The Registration Certificate of Imported Drug" which has been issued
      for the drug in question;

      3) The standards of the drug's quality, specifications and packaging;

      4) Other certificates which are required by laws and regulations to prove
      the authenticity of the advertisements' content.

      Application for the examination and approval of overseas-produced drugs'
      advertisements, to be published in China, can be made through a domestic
      drug dealer or advertising agent.

      Article 8
      The preliminary examination and approval of drug advertisements shall be
      conducted as follows:

      The departments in charge of the examination of drug advertisement shall
      check the authenticity, validity, legality, and integrity of certificates
      submitted by the applicant and examine the authenticity and legality of
      the advertisements' manuscript. It should make decision on the preliminary
      examination, within 10 days after accepting the application, and issue the
      Notice on Decision of the Preliminary Examination to the applicant.

      Article 9
      The final examination and approval of drug advertisements shall be
      conducted as follows:

      Having passed the preliminary examination, an applicant should summit the
      decision notice of preliminary examination together with the advertisement
      itself to the original advertisement examination department. The
      department should make a decision on final examination within 10 days
      after accepting the application. For those applicants which passing the
      final examination, the department should issue the Examination Form of
      Drug Advertisement and the approval number of the advertisement
      examination. And it should explain to applicants, who have failed to pass
      the examination, on the reason why their applications were not approved.

      An applicant can directly apply for the final examination and the
      advertisement examination department should make decision on it within 10
      days after accepting the application.

      Article 10
      The Notice of Decision on the Preliminary Examination of Drug
      Advertisement, and the Examination Form of Drug Advertisement, shall be
      signed by a competent official of the advertisement examination department
      and stamped with the official seal of the drug advertisement examination
      and approval department.

      The advertising examination department shall send the Examination Form of
      Drug Advertisement, which has been approved in the final examination, to
      the advertisement supervision department of the same level for record.

      Article 11
      The effective term of an approval certificate of drug advertisements is
      one year. For renewal of the approval, applications shall be submitted to
      the original examination and approval department two months before the
      expiry of the one-year term.

      Article 12
      If an approved advertisement is involved in any of the following cases,
      the examination department should recall the ads for re-examination. The
      use of such advertisement shall be suspended during the re-examination:

      1) When the condition, on which the examination was based, has changed;

      2) When the State Council public health administrative department
      considers the approval of the advertisement by a provincial-level
      examination department as inappropriate;

      3) When advertisement supervision departments suggest a re-examination;

      4) Other situations that make the advertisement examination and approval
      department consider it necessary to recall the advertisement for
      reexamination.

      Article 13
      An examination department should revoke the Examination Form of Drug
      Advertisement and cancel the approval certificate if the approved
      advertisement is involved in any of the following cases:

      1) When new malfunction of the advertised drug is discovered in clinic
      practice;

      2) When the official permit or business license of the drug producer or
      the drug dealer involved has been revoked by the authorities;

      3) When the drug has been deprived of its production certificate;

      4) When the contents of the drug advertisement extend beyond the scope as
      approved by the examination department;

      5) When the drugs are listed by the State as obsolete and shall be
      discarded;

      6) When the drug advertisement does not pass the re-examination;

      7) When the public health department considers the advertisement as
      inappropriate for publication;

      8) When the drug advertiser is under investigation by the advertisement
      supervision department.

      Article 14
      Drug advertisement, whose contents need revision or the quality standard
      of the drug involved has changed, shall be sent to the advertisement
      administrative department for re-examination and approval.

      Article 15
      An advertisement examination department shall submit the decision on
      revoking an approval certificate to the advertisement supervision
      department of the same level for reference.

      Article 16
      Where the drug advertisement examination and approval department has
      discovered that a drug advertisement has been published without obtaining
      official approval or approval certificate, or the advertisement's contents
      have gone beyond its approved scope, the department shall file a
      notification on illegal drug advertisement" and request the advertisement
      supervision department of the same level to investigate into and take
      action on the case, while notifying the examination and approval
      department on its findings and decision on the case.

      Article 17
      The registered number of approval certificate for drug advertisement and
      approval certificate for drug production shall be listed in the drug
      advertisement in question and published simultaneously.

      Article 18
      The drug advertisement agent shall design and make advertisements of
      drugs, for which applications have been filed for preliminary examination
      and approval, in accordance with the contents specified in the Notice of
      Decision on Preliminary Examination issued by the examination and approval
      department.

      Article 19
      Before running an advertisement, advertisement publishers shall first
      check the Examination Form of Drug Advertisements to verify the contents
      of such advertisement. The examination form should be the original
      document or its duplicate stamped by its original examination department,
      to be kept for one year. Advertisements shall not be published without
      official approval.

      Article 20
      Advertiser of non-drug products, which advertises the products' efficacy
      in treating disease, shall be considered as advertising fake drugs and
      punished, in accordance with Article 41 of the Advertisement Law of the
      People's Republic of China, by the advertisement supervision department.

      Article 21
      Those who published drug advertisements, in violation of these Measures or
      the Drug Advertisement Examination and Approval Standards, shall be
      punished in accordance with the relevant regulations of the Advertisement
      Law of the People's Republic of China, and the Drug Management Law of the
      People's Republic of China.

      Article 22
      Advertisement examination and approval department, which violates
      principles of advertisement examination, approves illegal advertisement
      and allows it publication, shall be reported by the State advertisement
      supervision departments to the State Council public health administrative
      department and shall be dealt with according to Article 45 of the
      Advertisements Law of the People's Republic of China.

      Article 23
      These Measures come into effect as of the date of promulgation.