The 12th meeting of the 13th the National People's Congress Standing Committee (NPCSC) concluded in Beijing, and the revised Drug Administration Law of People's Republic of China (PRC) was adopted. This is the second systematic and structural major revision of the law since the promulgation of 1984. In the future, people will usher in a series of new changes in drug purchase. According to CCTV news, on the morning of August 26th, the newly revised Drug Administration Law of People's Republic of China (PRC) was passed by vote, and will be implemented on February 6th, 20 19+ 1 year. This also means that a new version of the Drug Administration Law, which lasted for 19 years, will be published soon.

The main contents of the new drug administration law:

1, drug evaluation and quality inspection;

2. Supervision and management of medical devices;

3. Drug production and management;

4, drug use and safety supervision and management;

5. Standardized management of hospital pharmacy;

6. Drug inspection management;

7. Centralized bidding and purchasing management of drugs.

The tasks of drug maintenance are as follows:

1, to guide the custodian to store drugs scientifically;

2. Check whether the storage conditions of the drugs in stock meet the requirements, cooperate with the keeper to manage the temperature and humidity of other rooms, and adjust the storage conditions in time;

3. Regularly check the circulation quality of drugs in stock. The cycle of circulation sampling is generally one quarter, and the cycle of perishable drugs should be shortened;

4, the problems found in the spot check, put forward opinions and improve maintenance measures. Cooperate with the custodian to sort out the problematic varieties when necessary;

5, according to the change of seasonal climate, formulate drug inspection plan and maintenance work plan, list the key maintenance varieties, and implement them;

6. Establish drug maintenance files;

7. Sampling and observing key varieties, investigating the causes and laws of changes, and providing information for guiding rational inventory, improving storage level and promoting pharmaceutical factories to improve product quality;

8. Carry out scientific research on maintenance, and gradually make the storage and maintenance of warehouses scientific and modern.

Legal basis:

law for the control of drugs

Article 2 The drug supervision and administration department of the State Council shall establish a national drug inspection agency. _

The pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government may set up pharmaceutical inspection institutions within their respective administrative areas. The planning for the establishment of local drug inspection institutions shall be put forward by the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government and submitted to the people's governments of provinces, autonomous regions and municipalities directly under the Central Government for approval. The drug supervision and administration department of the State Council and the people's governments of provinces, autonomous regions and municipalities directly under the Central Government may, according to needs, determine inspection institutions that meet the requirements for drug inspection to undertake drug inspection.

Article 3 To establish a pharmaceutical production enterprise, a Pharmaceutical Production License shall be obtained in accordance with the following provisions:

(1) The applicant shall apply to the pharmaceutical supervisory and administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government where the enterprise is to be established. The pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, within 30 working days from the date of receiving the application, conduct a review according to the development plan and industrial policy of the pharmaceutical industry promulgated by the state, and make a decision on whether to approve the establishment. _

(two) after the applicant completes the preparation of the proposed enterprise, it shall apply to the original examination and approval department for acceptance. The original examination and approval department shall, within 30 working days from the date of receiving the application, organize the acceptance according to the opening conditions stipulated in Article 8 of the Drug Administration Law; Those who pass the inspection shall be issued a Pharmaceutical Production License. The applicant shall register with the administrative department for industry and commerce according to law with the Pharmaceutical Production License.

Article 4 Where a pharmaceutical production enterprise changes the licensed items of the Pharmaceutical Production License, it shall apply to the original license-issuing organ for registration of the change of the Pharmaceutical Production License 30 days before the change of the licensed items; Without approval, the licensing matters shall not be changed. The original issuing authority shall make a decision within 15 working days from the date of accepting the application. The applicant shall go through the formalities of change registration with the administrative department for industry and commerce according to law with the revised Pharmaceutical Production License.

Article 5 The pharmaceutical supervisory and administrative department of the people's government at or above the provincial level shall organize the certification of pharmaceutical production enterprises in accordance with the implementation measures and steps stipulated by the good manufacturing practice and the pharmaceutical supervisory and administrative department of the State Council; In line with the "good manufacturing practice", issued a certificate of certification. Among them, the certification of pharmaceutical production enterprises that produce injections, radioactive drugs and biological products as stipulated by the drug supervision and administration department of the State Council is the responsibility of the drug supervision and administration department of the State Council. _

The format of "good manufacturing practice" certification certificate shall be uniformly stipulated by the drug supervision and administration department of the State Council. _

Article 6 Newly-established pharmaceutical production enterprises, newly-built pharmaceutical production workshops or pharmaceutical production enterprises with new dosage forms shall, within 30 days from the date of obtaining the pharmaceutical production license or being approved for formal production, apply to the pharmaceutical supervisory and administrative department for good manufacturing practice certification in accordance with regulations. The pharmaceutical supervisory and administrative department that accepts the application shall organize the enterprise application within 6 months from the date of receiving the enterprise application.