(SDA Order No. 25)
Chapter 1: General Principles
Article 1: This Rules is promulgated in accordance with Article 22 of the Regulation for Administrative Protection of Drugs (hereinafter "Regulation").
Article 2: According to the Regulation, SDA is the administrative organ responsible for administrative protection of drugs.
Article 3: SDA shall establish an Office of Administrative Protection of Drugs which is responsible for:
(a)accepting and reviewing applications for: administrative protection, revocation of administrative protection, and handling of infringement matters;
(b)granting or denying approval for administrative protection;
(c)revocation of administrative protection and handling infringement matters;
(d)establishing a registration book to record acceptance, granting or denial of approval, revocation and termination of administrative protection;
(e)publication of acceptance, granting or denial of approval, revocation and termination of administrative protection; and,
(f)other matters related to the administrative protection of drugs.
Article 4: The term "owner of exclusive rights" referred to in the Regulation means the person who has the complete rights for the manufacture, use and sales of a drug for which application is made for administrative protection.
Article 5: The term "drug" referred in the Regulation means a substance that is used in the prevention, treatment or diagnosis of human diseases with prescribed indications, usage and dosage, for the targeting of human physiology.
Chapter 2: Application for Administrative Protection of Drugs
Article 6: The phrase "not yet marketed in China" referred to in Article 5(3) of the Regulation means that a drug for which application has been made for administrative protection shall not yet have been distributed through lawful channels in the Chinese pharmaceutical market.
Article 7: The term "agent" referred to in Article 7 of the Regulation means an agent designated by SDA.
Article 8: SDA shall establish uniform forms for administrative protection, including the application and other relevant documents.
Article 9: The term "foreign language" referred to in Article 8 of the Regulation means the official language of the country of the applicant.
Article 10: When an applicant authorizes an agent to handle application matters for administrative protection, both parties shall sign a power of attorney which defines the scope of authorization.
The agent shall submit the power of attorney together with other application documents according to Article 8 of the Regulation and this Rules.
Article 11: Each application for administrative protection is limited to one drug.
Article 12: The application form referred to Article 8(1) of the Regulation, shall include the following items:
(a)name and address of the applicant;
(b)nationality of the applicant;
(c)for an applicant which is an enterprise or other organization, the name of the country or region of its corporate headquarters;
(d)name (generic name, brand name, chemical name), chemical structure, formulation, dosage form, indications, directions for administration, dosage, and a brief introduction to the processing technology of the pharmaceutical;
(e)signatures (seals) of the applicant and the agent;
(f)list of the application documents; and,
(g)any other matters which should be noted.
Article 13: The submitted documents shall be neat and clear. Attached diagrams shall meet relevant standards and specifications and shall not be altered. Technical terms used in application documents shall be the standardized terms uniformly adopted in China [assuming such term has been adopted in China].
Article 14: The documents referred to in Article 8(2), (3) of the Regulation shall be notarized, certified or authenticated in the country of the applicant.
The document referred to in Article 8(4) of the Regulation shall be notarized by a Chinese notary organization.
Article 15: The Chinese legal entity which signed the submitted pharmaceutical manufacturing contract, referred to in Article 8(4) of the Regulation, shall possess a Drug Manufacturing License and a Pharmaceutical Business License; the Chinese legal entity which signed the submitted sales contract shall possess a Pharmaceutical Business License and a Legal Enterprise Business License.
In submitting the manufacturing or sales contract, the applicant shall also attach photocopies of the above licenses.
Article 16: In making application for administrative protection, an applicant shall submit all relevant documents. SDA shall not accept an application in either of the following situations:
(a) failure to use the required forms or complete the forms as required;
(b)failure to submit relevant documents as required.
Article 17: If prior to the issuance of the certificate of administrative protection, the applicant requests to withdraw the application, the applicant shall submit a written application of revocation to SDA, indicating the applicant's name and drug name.
Chapter 3: Term, Termination, Revocation, and Effect
Article 18: The term "date of issuance of the certificate of administrative protection for a drug (hereinafter "Certificate")" referred in Article 13 of the Regulation shall be the date indicated on the Certificate.
Article 19: SDA shall be responsible for publication according to the Regulation and this Rules.
Article 20: Within the term [period of legal effect] of administrative protection of a drug, the owner of the exclusive rights shall duly submit documents to SDA showing the continued legal effectiveness of the applicant's right of exclusivity.
Article 21: According to Article 15 of the Regulation, in requesting revocation of administrative protection a Petition for Revocation of Administrative Protection of a Drug (hereinafter "Petition for Revocation") and other relevant documents shall be submitted in duplicate. The Petition for Revocation shall include:
(a)name, address and nationality of the petitioner;
(b)name and address of the respondent [grantee/recipient of administrative protection];
(c)the name of the drug for which the petitioner requests revocation and its approval number;
(d)the basis and evidence for the Petition for Revocation.
Each Petition for Revocation is limited to one drug.
Article 22: After receipt, SDA shall review a Petition for Revocation to determine whether, based on facts and legal arguments, it presents a prima facie case according to the Regulation, and issue a notice of acceptance or rejection.
For a Petition for Revocation which is accepted, SDA shall send a duplicate copy and other relevant documents to the owner of exclusive rights ("respondent") requesting a written answer within a prescribed time. The failure of the respondent to duly file a written answer will not affect the conducting of an examination by SDA.
Article 23: Upon completion of the examination, SDA shall determine whether to revoke the administrative protection, or dismiss the Petition for Revocation and thus maintain administrative protection for the drug. SDA shall notify the parties in writing and publish its decision.
Article 24: If a generic of the originator's drug obtained approval for clinical trials before the date of [acceptance] of the originator's application for administrative protection and obtained SDA approval for manufacture before the date of the grant of administrative protection, it may continue to be manufactured and sold after the grant of administrative protection within the scope of its approvals. However, [its licenses for manufacture and sale] may not be transferred to a third party.
Chapter 4: Handling of Infringement
Article 25: An owner of exclusive rights may petition SDA to handle infringement matters within two years from the date it knows or should know about the infringement [the failure to petition SDA within this two year statutory term (also called "statute of limitations") presumably results in the waiver of these rights].
Article 26: The owner of exclusive rights petitioning SDA shall submit a Petition to SDA for the Handling of the Cessation of Actions Infringing on Administrative Protection Rights (hereinafter "Petition to Cease Infringement"), which shall indicate:
(a)name, address and nationality of the petitioner;
(b)name and address of the respondent [infringer];
(c)name of the drug being infringed and its approval number;
(d)allegations of infringement; and,
(e)facts and corresponding evidence showing infringement.
Duplicate copies of the Petition to Cease Infringement shall be prepared in the number of respondents. Each Petition to Cease Infringement is limited to one drug.
Article 27: SDA shall accept a Petition to Cease Infringement which meets requirements and send a duplicate to each respondent requesting a written answer within a prescribed time period.
Article 28: If necessary, SDA may hold a hearing with the participation of the petitioner and respondent(s) at which evidence is presented, evaluated, and argued.
Article 29: SDA shall determine whether a respondent has committed infringement, dismissing petitions where actions do not constitute infringement, and, according to law, stopping actions which constitute infringement.
Article 30: Upon determination by SDA of infringement, the owner of exclusive rights may sue in People's Court for economic compensation.
Article 31: If a respondent or a third party submits a Petition for Revocation during the process of handling the infringement matter, SDA shall [possibly "may"] suspend the handling of the infringement matter until the conclusion of the revocation matter, then either resume or terminate the handling of the infringement matter.
Chapter 5: Fees
Article 32: Fees shall be required for the application for administrative protection and following related matters:
(f)petitioning for revocation; and
(g)handling of infringement.
SDA shall publish a standard of the above fees.
Article 33: An applicant shall pay the application fee upon the submission of the application for administrative protection; pay the examination and publication fees within one month from the date of the acceptance notice. An application shall be considered as withdrawn if, without appropriate reasons, a fee is not duly paid (including partial payment).
Article 34: The owner of exclusive rights for a drug that has been granted administrative protection shall, within one month from date of issuance of the Certificate, pay the following fees: certificate, publication and the annual fee for the current year. Within the term of administrative protection, the annual fee should be paid within the first two months of each year. If, without appropriate reasons, the annual fee is not duly paid, the right to administrative protection is automatically considered waived.
Article 35: The fee for the Petition for Revocation should be paid upon its submission.
Article 36: The owner of exclusive rights shall pay the fee the Petition to Cease Infringement upon its submission.
Article37: All the fees prescribed by Article 33 of this Rules shall be collected by the "agent".
Chapter 6: Miscellaneous
Article 38: Unless otherwise stated in the Regulation and this Rules, the first day for all the time periods shall not be counted. For a time period calculated by year or month, the corresponding day in the last month of each period shall be the end of the period; if there is no corresponding day in the month, then the last day of the month shall be the end of the period. If the last day of a time period falls on a legal holiday, then the first working day after the holiday shall be the end of the time period.
Article 39: SDA shall be responsible for the interpretation of this Rules.
Article 40: This Rules shall be effective since the date of issuance. The Rules for the Administrative Protection of Drugs issued by the former State Pharmaceutical Administration of China (SPAC) on December 30, 1992, shall be simultaneously annulled. This Rules supercedes any inconsistent provisions of previously published regulations.