Rules for the Administrative Protection of Drugs - 2000

Rules for the Administrative Protection of Drugs - 2000

Order of the State Food And Drug Administration No.25

October 24, 2000

The Rules For The Administrative Protection Of Drugs were passed at the executive meeting of the State Food and Drug Administration on 14 April 2000, and are hereby announced with immediate effect.

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
1.accepting and reviewing applications for administrative protection, revocation of administrative protection, and handling of infringement matters;
2.granting or denying approval for administrative protection;
3.revocation of administrative protection and handling infringement matters;
4.establishing a registration book to record acceptance, granting or denial of approval, revocation and termination of administrative protection;
5.publication of acceptance, granting or denial of approval, revocation and termination of administrative protection; and,
6.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
1.name and address of the applicant;
2.nationality of the applicant;
3.for an applicant which is an enterprise or other organization, the name of the country or region of its corporate headquarters;
4.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;
5.signatures (seals) of the applicant and the agent;
6.list of the application documents; and,
7.any other matters which should be noted.
　
Article 13 The submitted documents shall be neat and clear.
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