Detailed rules for the implementation of quality registration of Chinese medicine products for export (for Trial Implementation)

Chapter I General Provisions Article 1 These Detailed Rules are formulated in accordance with the Drug Administration Law of People's Republic of China (PRC) for the purpose of ensuring the quality of exported traditional Chinese medicine products, maintaining the international reputation of exported traditional Chinese medicine products and strengthening the quality management of exported traditional Chinese medicine products. Article 2 state administration of traditional chinese medicine is responsible for the quality registration management of Chinese medicine products exported nationwide. Article 3 Chinese medicine products for export must be inspected by quality inspection institutions designated by state administration of traditional chinese medicine. Chapter II Conditions for Quality Registration Article 4 An enterprise applying for quality registration of Chinese medicine products for export shall meet the following conditions:

(1) Enterprises exporting traditional Chinese medicine products must have the Certificate of Pharmaceutical Production Enterprise issued by state administration of traditional chinese medicine, the License of Pharmaceutical Production Enterprise issued by the administrative department of health and the Business License issued by the administrative department for industry and commerce.

(two) production enterprises must abide by the good manufacturing practice (GMP), establish and improve the product quality assurance system, and strictly improve the management system and assessment system. The quality inspection department has veto power over product quality.

(3) Having production equipment, processes, inspection instruments and test equipment to ensure the quality of traditional Chinese medicine products.

(four) there are professional quality inspection technicians to ensure product quality.

(5) Have complete and correct design data, process documents, inspection regulations and inspection records.

(six) the enterprise should obtain the qualification certificate of measurement above grade three. Article 5 Requirements for applying for exporting traditional Chinese medicine products

(a) the quality standards of Chinese medicine products applied for export shall meet or be higher than the current version of People's Republic of China (PRC) Pharmacopoeia, the drug standards of the Ministry of Health and local standards.

(two) the instructions for the export of traditional Chinese medicine products must indicate the prescription and dosage.

(3) There are qualitative and quantitative quality standards and detection methods for the main components or index components in the quality standards of Chinese medicine products for export.

(4) The quality standards of Chinese medicine products for export include the limit inspection of harmful substances and the limit inspection of impurities that meet the international advanced standards. Chapter III Basis for Quality Registration Article 6 The quality of Chinese medicine products for export is based on the national standards and industrial standards formulated by state administration of traditional chinese medicine, and meets the quality requirements of first-class products and excellent products in the General Standards for Chinese Patent Medicines. Article 7 The quality of Chinese medicine products for export may also adopt the standards of the importing country, the international general technical standards or the contract standards of both parties. Article 8 state administration of traditional chinese medicine implements a quality registration system for exported Chinese medicine products, and state administration of traditional chinese medicine entrusts quality supervision and inspection institutions for exported Chinese medicine products to conduct quality inspection. After passing the inspection, state administration of traditional chinese medicine will issue a quality registration certificate for Chinese medicine products for export. Chapter IV Product Quality Registration Procedures Article 9 Export enterprises of traditional Chinese medicine products must register product quality. A registered enterprise or legal representative (hereinafter referred to as the applicant) shall submit a written application according to the following terms.

(1) An enterprise exporting traditional Chinese medicine products may obtain from state administration of traditional chinese medicine and fill out the Application Form for Quality Registration of Exported Traditional Chinese Medicine Products in quadruplicate. The required information shall be reviewed and sealed by the pharmaceutical administrations of all provinces, autonomous regions and municipalities directly under the Central Government and then reported to state administration of traditional chinese medicine for handling.

(2) The applicant pays the export product quality registration fee to state administration of traditional chinese medicine. Article 10 Export products shall be accompanied by quality standards and testing methods, and testing units designated by the State Administration of Traditional Chinese Medicine shall conduct inspection according to the reported product quality standards. Eleventh testing units shall issue inspection reports within 20 days after receiving the samples. Under special circumstances, if the inspection report cannot be issued on time, it is necessary to explain the situation to the inspected unit and state administration of traditional chinese medicine. Twelfth of the products that pass the inspection, the inspection unit shall fill in the "Quality Inspection Report of Chinese Medicine Products for Export" and submit it to state administration of traditional chinese medicine for examination. If the product is unqualified, the testing organization will issue a "notice of disqualification" to state administration of traditional chinese medicine and the applicant. After the product is improved, you can re-apply for quality registration. Article 13 For qualified products, the State Administration of Traditional Chinese Medicine directly organizes or entrusts local pharmaceutical authorities to conduct on-site management and civilized production management assessment of the factory, and the State Administration of Traditional Chinese Medicine will issue a quality registration certificate for exported Chinese medicine products. Fourteenth products that have been approved to use the quality registration certificate should be re-registered when the corresponding laws and standards change. Chapter V Supervision and Administration Article 15 state administration of traditional chinese medicine conducts regular spot checks and re-inspections on enterprises, products and site management that have been approved to use the quality registration certificate of Chinese medicine products for export. Sixteenth registered products are valid for three years from the date of registration. During this period, if the product standards are revised or the importing country has other new requirements and new quality standards are added, the enterprise should be re-registered. Seventeenth six months before the expiration of the validity period, the applicant must apply to state administration of traditional chinese medicine for re-registration, and the registration certificate will be automatically revoked three months after the expiration. Article 18 state administration of traditional chinese medicine will stop using the registration certificate in case of any of the following circumstances for the products using the registration certificate and their manufacturing enterprises.

(a) in the re-inspection and spot check, it is found that it does not meet the conditions stipulated in Chapter II of these Measures, and it still fails to meet the requirements within the time limit.

(2) During the validity period, if the quality of the product is seriously degraded and domestic and foreign customers demand compensation or return, the responsibility lies with the manufacturer.

(three) when the testing unit conducts inspection according to the standard, there are some unqualified people.