Implementing Regulations of the Drug Administration Law of the People's Republic of China (Revised in 2016)
Implementing Regulations of the Drug Administration Law of the People's Republic of China (Revised in 2016)
Implementing Regulations of the Drug Administration Law of the People's Republic of China (Revised in 2016)
Order of the State Council No.666
February 6, 2016
(Promulgated by the Order of the State Council of the People's Republic of China No.360 on August 4, 2002; and revised in accordance with the Decision of the State Council on Revising Certain Administrative Regulations by the Order of the State Council of the People's Republic of China No.666 on February 6, 2016)
Chapter I General Provisions
Article 1 These Regulations are formulated in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law).
Article 2 The pharmaceutical regulatory department under the State Council shall establish state pharmaceutical inspection institute.
The pharmaceutical regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government may establish pharmaceutical inspection institute within its respective administrative area. The plan for the establishment of local pharmaceutical inspection institutes shall be proposed by the pharmaceutical regulatory department of the people's government of the province, autonomous region and municipality directly under the Central Government and submitted to the people's government of the province, autonomous region and municipality directly under the Central Government for approval.
The pharmaceutical regulatory department under the State Council and the pharmaceutical regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government may, when necessary, designate inspection institute fulfilling the requirements for pharmaceutical inspection to undertake the pharmaceutical inspection.
Chapter II Administration of the Pharmaceutical Producing enterprises
Article 3 To establish a drug manufacturer, the applicant shall submit an application to the drug regulatory department of the people's government of the province, autonomous region or municipality directly under central government where the manufacturer is to be located. The drug regulatory department of the people's government of the province, autonomous region or municipality directly under central government shall, within 30 working days from the date it receives the application, arrange an acceptance inspection according to the requirements for the establishment of such manufacturers in Article 8 of the Drug Administration Law, and issue a Drug Manufacturing Certificate to the applicant if the inspection is passed.
Article 44 Packaging materials and containers selected for the production of prepared slices of the traditional Chinese medicine shall accommodate to pharmaceutical properties. No prepared slices of a traditional Chinese medicine shall be marketed with package fails to conform to the regulations. A label shall be printed on or attached to the package of prepared slices of traditional Chinese medicine.
The label of prepared slices of traditional Chinese medicine shall indicate the name of the pharmaceutical, specifications, origin of production, manufacturer, product batch number and production date; if the said pharmaceutical is controlled by approval number, the pharmaceutical approval number shall also be indicated.
Article 45 The package, label and insert sheet of a pharmaceutical shall be printed in accordance with the provisions of Article 54 of the Drug Administration Law and those formulated by the pharmaceutical regulatory department under the State Council.
The trade name of a pharmaceutical shall conform to the provisions of the pharmaceutical regulatory department under the State Council.
Article 46 The immediate packaging materials and containers, used by medical institutions for dispensing pharmaceutical preparations, as well as the labels and insert sheets thereof, shall conform to the provisions of Chapter VI of the Drug Administration Law and the relevant provisions in these Regulations, and be subject to approval by the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government.
Chapter VII Control over Pharmaceutical Pricing and Advertising
Article 47 The competent pricing department of the government may, in practicing pharmaceutical price monitoring according to the provisions of Article 28 of the Pricing Law, appoint certain pharmaceutical manufactures, pharmaceutical trading enterprises and medical institutions as pharmaceutical price monitoring units for the purpose of understanding and analyzing the changes and trends of pharmaceutical prices; the appointed units shall provide cooperation, support and truthful information.
Article 48 To publish a pharmaceutical advertisement, the relevant materials shall be submitted to the local pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where the pharmaceutical manufacturer is located. The pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within ten working days after it receives the relevant materials, make a decision upon examination on whether to issue the approval number for the pharmaceutical advertisement.
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Order of the State Council No.666
February 6, 2016
(Promulgated by the Order of the State Council of the People's Republic of China No.360 on August 4, 2002; and revised in accordance with the Decision of the State Council on Revising Certain Administrative Regulations by the Order of the State Council of the People's Republic of China No.666 on February 6, 2016)
Chapter I General Provisions
Article 1 These Regulations are formulated in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law).
Article 2 The pharmaceutical regulatory department under the State Council shall establish state pharmaceutical inspection institute.
The pharmaceutical regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government may establish pharmaceutical inspection institute within its respective administrative area. The plan for the establishment of local pharmaceutical inspection institutes shall be proposed by the pharmaceutical regulatory department of the people's government of the province, autonomous region and municipality directly under the Central Government and submitted to the people's government of the province, autonomous region and municipality directly under the Central Government for approval.
The pharmaceutical regulatory department under the State Council and the pharmaceutical regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government may, when necessary, designate inspection institute fulfilling the requirements for pharmaceutical inspection to undertake the pharmaceutical inspection.
Chapter II Administration of the Pharmaceutical Producing enterprises
Article 3 To establish a drug manufacturer, the applicant shall submit an application to the drug regulatory department of the people's government of the province, autonomous region or municipality directly under central government where the manufacturer is to be located. The drug regulatory department of the people's government of the province, autonomous region or municipality directly under central government shall, within 30 working days from the date it receives the application, arrange an acceptance inspection according to the requirements for the establishment of such manufacturers in Article 8 of the Drug Administration Law, and issue a Drug Manufacturing Certificate to the applicant if the inspection is passed.
Article 44 Packaging materials and containers selected for the production of prepared slices of the traditional Chinese medicine shall accommodate to pharmaceutical properties. No prepared slices of a traditional Chinese medicine shall be marketed with package fails to conform to the regulations. A label shall be printed on or attached to the package of prepared slices of traditional Chinese medicine.
The label of prepared slices of traditional Chinese medicine shall indicate the name of the pharmaceutical, specifications, origin of production, manufacturer, product batch number and production date; if the said pharmaceutical is controlled by approval number, the pharmaceutical approval number shall also be indicated.
Article 45 The package, label and insert sheet of a pharmaceutical shall be printed in accordance with the provisions of Article 54 of the Drug Administration Law and those formulated by the pharmaceutical regulatory department under the State Council.
The trade name of a pharmaceutical shall conform to the provisions of the pharmaceutical regulatory department under the State Council.
Article 46 The immediate packaging materials and containers, used by medical institutions for dispensing pharmaceutical preparations, as well as the labels and insert sheets thereof, shall conform to the provisions of Chapter VI of the Drug Administration Law and the relevant provisions in these Regulations, and be subject to approval by the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government.
Chapter VII Control over Pharmaceutical Pricing and Advertising
Article 47 The competent pricing department of the government may, in practicing pharmaceutical price monitoring according to the provisions of Article 28 of the Pricing Law, appoint certain pharmaceutical manufactures, pharmaceutical trading enterprises and medical institutions as pharmaceutical price monitoring units for the purpose of understanding and analyzing the changes and trends of pharmaceutical prices; the appointed units shall provide cooperation, support and truthful information.
Article 48 To publish a pharmaceutical advertisement, the relevant materials shall be submitted to the local pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where the pharmaceutical manufacturer is located. The pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within ten working days after it receives the relevant materials, make a decision upon examination on whether to issue the approval number for the pharmaceutical advertisement.
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