Full text of the new “Drug Administration Law of the People's Republic of China”

City license. The transferee shall have the quality management, risk prevention and control, and liability compensation capabilities to ensure the safety, effectiveness, and quality controllability of drugs, and perform the obligations of the drug marketing license holder.

Chapter IV Drug Production

Article 41 To engage in drug production activities, a drug production license shall be obtained with the approval of the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government. No drug production shall be allowed without a drug production license.

The drug production license shall indicate the validity period and production scope, and shall be reviewed and reissued upon expiration.

Article 42 To engage in drug production activities, the following conditions shall be met:

(a) There are pharmaceutical technicians, engineering technicians, and corresponding technical workers who have been qualified in accordance with the law;

(b) There are factory buildings, facilities, and sanitary environment suitable for drug production;

(c) There are institutions, personnel, and necessary instruments and equipment that can carry out quality management and quality inspection of the drugs produced;

(d) There are rules and regulations to ensure drug quality, and they meet the requirements of the drug production quality management standards formulated by the drug supervision and administration department of the State Council in accordance with this Law.

Article 43: Those engaged in drug production activities shall comply with the drug production quality management standards, establish and improve the drug production quality management system, and ensure that the entire drug production process continues to meet the statutory requirements.

The legal representative and main person in charge of a drug production enterprise shall be fully responsible for the drug production activities of the enterprise.

Article 44: Drugs shall be produced in accordance with national drug standards and production processes approved by the drug supervision and administration department. Production and inspection records shall be complete and accurate and shall not be fabricated.

Chinese herbal medicines shall be prepared in accordance with national drug standards; if not specified in national drug standards, they shall be prepared in accordance with the preparation specifications formulated by the drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government. The preparation specifications formulated by the drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall be filed with the drug supervision and administration departments of the State Council. Drugs that do not meet national drug standards or are not prepared in accordance with the preparation specifications formulated by the drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall not be shipped or sold.

Article 45: The raw materials and excipients required for the production of drugs shall meet the requirements for medicinal use and the relevant requirements of drug production quality management standards.

In the production of drugs, the suppliers of raw materials and auxiliary materials shall be reviewed in accordance with the regulations to ensure that the raw materials and auxiliary materials purchased and used meet the requirements of the preceding paragraph.

Article 46 Packaging materials and containers that directly contact drugs shall meet the requirements of medicinal use and the standards for protecting human health and safety.

The drug supervision and administration department shall order the suspension of use of unqualified packaging materials and containers that directly contact drugs.

Article 47 Drug manufacturers shall conduct quality inspections on drugs. Drugs that do not meet national drug standards shall not be shipped out of the factory.

Drug manufacturers shall establish factory release procedures for drugs and specify the standards and conditions for factory release. If the standards and conditions are met, they can be released only after the signature of the quality authorized person.

Article 48 Drug packaging shall be suitable for drug quality requirements and convenient for storage, transportation and medical use.

Traditional Chinese medicinal materials shall be packaged when shipped. The name, origin, date, and supplier of each package shall be indicated, and a quality certification mark shall be attached.

Article 49: Drug packaging shall be printed or affixed with labels and accompanied by instructions in accordance with regulations.

The labels or instructions shall indicate the generic name, ingredients, specifications, marketing authorization holder and address, manufacturer and address, approval number, product batch number, production date, validity period, indications or main functions, usage, dosage, contraindications, adverse reactions and precautions of the drug. The text on the labels and instructions shall be clear, and matters such as production date and validity period shall be marked prominently and easily recognizable.

The labels and instructions of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, external drugs and over-the-counter drugs shall be printed with prescribed signs.

Article 50: The staff of drug marketing authorization holders, drug manufacturers, drug dealers and medical institutions who have direct contact with drugs shall undergo health examinations every year. Those who suffer from infectious diseases or other diseases that may contaminate drugs shall not be engaged in work that directly contacts drugs.

Specific news link: "Drug Administration Law of the People's Republic of China"