Regulations for the Implementation of the Drug Administration Law of the People's Republic of China (2019 Amendment)

Regulations for the Implementation of the Drug Administration Law of the People's Republic of China (2019 Amendment) Regulations for the Implementation of the Drug Administration Law of the People's Republic of China (Promulgated by the Order No. 360 of the State Council of the People's Republic of China on August 4, 2002; revised in accordance with the Decision of the State Council on Amending Some Administrative Regulations on February 6, 2016; and amended in accordance with the Decision of the State Council to Amend Certain Administrative Regulations on March 2, 2019) Chapter 1 General Provisions Article 1 The 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 drug regulatory department under the State Council shall establish a national drug testing institute. The drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government may establish drug testing institutes within its respective administrative area. The plan for the establishment of local drug testing institutes shall be proposed by the drug 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 drug regulatory department under the State Council and the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government may, when necessary, designate any testing institute fulfilling the requirements for drug testing to undertake drug testing. Chapter II Control over Drug Manufacturers Article 3 To form a pharmaceutical manufacturing enterprise, the applicant shall file the application with the drug administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the manufacturing enterprise is to be located. The drug administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall, within 30 working days of receipt of the application, organize inspection according to the conditions for formation prescribed in Article 8 of the Pharmaceutical Administration Law ; and if the inspection is passed, a Pharmaceutical Production Permit shall be issued. Article 4 Any drug manufacturer that intends to alter the approved items in the Drug Manufacturing Certificate shall, 30 days prior to alteration of any approved items, apply to the original certificate-issuing authority for registration of alteration; no approved items may be altered without approval. The original certificate-issuing authority shall make a decision within 15 working days from the date it receives the application. Article 5 The drug regulatory department of the people's government at or above the provincial level shall organize inspections of drug manufacturers in accordance with the Good Manufacturing Practice for Pharmaceutical Products (GMP) and the measures and schedule for implementing the GMP formulated by the drug regulatory department under the State Council, and issue a certificate to the manufacturer that complies with the GMP. For the manufacturer producing injections or radioactive pharmaceuticals and for that producing biological products specified by the drug regulatory department under the State Council, the inspection of which shall be conducted by the drug regulatory department under the State Council. The format of GMP certificate shall be uniformly provided for by the drug regulatory department under the State Council. Article 6 Any newly-established drug manufacturer or manufacturer with newly-built drug manufacturing workshops or newly-added dosage forms for production shall, within 30 days from the date it obtains the approval documents for manufacturing drug or from the date its formal production is approved, apply to the drug regulatory department for GMP certification as required. The drug regulatory department accepting the application shall, within six months from the date it receives the application, organize inspections as to the compliance with the GMP requirements by the applying manufacturer. A certificate shall be issued to the manufacturer if the inspection is passed. Article 7 The drug regulatory department under the State Council shall set up a database of GMP inspectors. A GMP inspector shall be qualified as required by the drug regulatory department under the State Council. A GMP inspection shall be conducted by a team of inspectors randomly selected from the database of GMP inspectors according to the provisions of the drug regulatory department under the State Council. Article 8 The valid term of a Drug Manufacturing Certificate is five years. To continue its drug production, the Certificate holder shall, six months prior to the expiry date of the Certificate, apply for the renewal of the Drug Manufacturing Certificate according to the provisions of the drug regulatory department under the State Council. Where a drug manufacturer terminates its drug production or is closed down, its Drug Manufacturing Certificate shall be withdrawn by the original certificate-issuing authority. Article 9 Any drug substance used by a drug manufacturer to produce drug products shall have a drug approval number or an import drug license or a pharmaceutical product license issued by the drug regulatory department under the State Council upon examination, with the exception of Chinese crude drugs and the prepared slices of Chinese crude drugs over which no control by approval number is exercised. Article 10 In accordance with the provisions in Article 13 of the Drug Administration Law , any drug manufacturer being entrusted with contract production of the drug shall have a GMP certificate corresponding to the contracted drug. No vaccines, blood products or other drugs specified by the drug regulatory department under the State Council may be contracted for production. Chapter III Control over Drug Distributors Article 11 For establishment of a drug wholesaler, 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 the Central Government, where the planned drug wholesaler is to be located. The drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within 30 working days from the date it receives the application, make a decision on approval or disapproval according to the standards for establishment set forth by the drug regulatory department under the State Council. After completion of establishment of the planned wholesaler, the applicant shall apply to the original approving department for acceptance inspection. The original approving department shall, within 30 working days from the date it receives the application, organize an acceptance inspection according to the requirements for establishment of drug distributors set forth in Article 15 of the Drug Administration Law and issue the Drug Supply Certificate to the applicant if the inspection is passed. Article 12 For establishment of a drug retailer, the applicant shall submit an application to the drug regulatory institution of the municipality divided into districts, or to the drug regulatory institution at the county level which is directly set up by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, where the planned retailer is to be located. The drug regulatory institution accepting the application shall, within 30 working days from the date it receives the application, make a decision on approval or disapproval after the review according to the provisions of the drug regulatory department under the State Council, taking into consideration the number of permanent residents, territory, transportation and practical needs in the place. After completion of establishment of the planned retailer, the applicant shall apply to the original approving department for acceptance inspections. The original approving department shall, within 15 working days from the date it receives the application, organize acceptance inspections according to the requirements for establishment of drug distributors set forth in Article 15 of the Drug Administration Law and issue a Drug Supply Certificate if inspections are passed. Article 13 The drug administrative departments of the people's governments of provinces, autonomous regions, or municipalities directly under the Central Government and the drug administrative agencies at the level of a districted city shall be responsible for organizing the certification of pharmaceutical trading enterprises. A pharmaceutical trading enterprise shall, according to the implementation measures and the implementation steps prescribed by the drug administrative department of the State Council, pass the certification of compliance with the Good Distribution Practices for Pharmaceutical Products (“GDP”) organized by the drug administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government or the drug administrative agency at the level of a districted city, and obtain a GDP certificate. The format of a GDP certificate shall be uniformly prescribed by the drug administrative department of the State Council. A newly-formed pharmaceutical wholesaler or retailer shall, within 30 days of obtaining the Pharmaceutical Distribution Permit, apply for the HYPERLINK "javascript:ESLC(250539,0)" GDP certification to the drug administrative department or agency which issued the Pharmaceutical Distribution Permit to it. The drug administrative department or agency accepting the application shall, within three months of receipt of the application, organize the certification of GDP compliance of the pharmaceutical wholesaler or retailer applying for certification in accordance with the provisions issued by the drug administrative department of the State Council, and issue a HYPERLINK "javascript:ESLC(250539,0)" GDP certificate to the pharmaceutical wholesaler or retailer if it passes the certification. Article 14 A database of GSP inspectors shall be set up by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government. A GSP inspector shall be qualified as required by the drug regulatory department under the State Council. A GSP inspection shall be conducted by a team of inspectors randomly selected from the said database according to the provisions of the drug regulatory department under the State Council. Article 15 The State adopts a classification system for prescription drugs and non-prescription drugs. The State subdivides non-prescription drugs into Class A drugs and Class B drugs according to the level of safety. Any drug retailer distributing prescription drugs or Class A non-prescription drugs shall have licensed pharmacists or other pharmaceutical technicians whose qualifications are legally recognized. Any retailer distributing Class B non-prescription drugs shall have pharmacy staff members who have passed the examination organized by the local drug regulatory institution of the municipality divided into districts or by the local drug regulatory institution at the county level which is directly set up by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government. Article 16 Any drug distributor that intends to alter the approved items in the Drug Supply Certificate shall, 30 days prior to the alteration of any approved items, apply to the original certificate-issuing authority for registration of alteration; no approved items may be altered without approval. The original certificate-issuing authority shall make a decision within 15 working days from the date it receives the application. Article 17 The valid term of a Drug Supply Certificate is five years. To continue its drug distribution, the Certificate holder shall, six months prior to the expiry date of the Certificate, apply for the renewal of the Drug Supply Certificate according to the provisions of the drug regulatory department under the State Council. Where a drug distributor terminates its drug distribution or is closed down, its Drug Supply Certificate shall be withdrawn by the original certificate-issuing authority. Article 18 Where there is no drug retailers at town or country fairs in remote areas with poor communications, the local drug retailers may, after obtaining approval from the local drug regulatory institution of the county (municipality) and being registered with the administrative department for industry and commerce, set up stores at the fairs to sell non-prescription drugs within the approved scope for drug distribution. Article 19 Drug manufactures, drug distributors and medical institutions engaged in on-line drug transactions through Internet and the drugs so transacted shall be in conformity with the provisions in the Drug Administration Law and in the Regulations. The measures for administration of on-line drug distribution services shall be formulated by the drug regulatory department under the State Council jointly with the other relevant departments under the State Council. Chapter IV Control over Pharmaceuticals in Medical Institutions Article 20 To establish a pharmaceutical preparation unit in a medical institution, an application shall be submitted to the local health administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government, and, after being consented upon examination, be presented to the drug regulatory department of the people's government at the same level for review and approval. Approval shall be given to the medical institution if it passes the review by the said drug regulatory department and a Pharmaceutical Preparation Certificate for Medical Institution shall be issued to it. The health administrative department and the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within 30 working days from the dates they receive the application respectively, make their own decisions whether or not to consent or approve the application accordingly. Article 21 Any medical institution that intends to alter the approved items in the Pharmaceutical Preparation Certificate for Medical Institution shall, 30 days prior to the alteration of any approved items, apply to the original examining and approving departments for registration of alteration according to the provisions in Article 20 of the Regulations; no approved items may be altered without approval. The original examining and approving departments shall make their own decisions within 15 working days from the dates they receive the application respectively. Any medical institution which intends to add new dosage forms or change dispensing sites shall, after passing the acceptance inspection by the local drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, go through the registration of alteration of the Pharmaceutical Preparation Certificate for Medical Institution according to the provisions in the preceding paragraph. Article 22 The valid term of a Pharmaceutical Preparation Certificate for Medical Institution is five years. To continue dispensing pharmaceutical preparation, the medical institution sh......