At one time, September was regarded as the quadruple confirmation period of domestic policy and enterprise profit. Many policies of pharmaceutical manufacturing industry will be implemented in September. These new policies and regulations will affect the whole industry, every enterprise and every medical person. Following is a brief inventory of the upcoming earth-shaking changes in the pharmaceutical manufacturing industry in September.

Measures for the Management of Medical Consumables in Medical Institutions (Trial Implementation)

On September 1, the "Measures for the Management of Medical Consumables in Medical Institutions (Trial Implementation)", jointly issued by the State Health Commission and the State Administration of Traditional Chinese Medicine, began to be implemented.

The Measures have made relevant requirements on the management objects, contents, procurement and management system of consumables. Among them, medical institutions should implement the relevant provisions of hospital affairs disclosure, include the main medical consumables in the scope of active disclosure, and publicize relevant information such as brand regulations, supply enterprises and prices.

This also means that the procurement of medical consumables will be more transparent and open, and the industry will be further standardized, which is conducive to reducing the cost burden of patients.

Collection, mining and expansion face, gradually pushing forward to the whole country

On September 1, Shanghai Sunshine Pharmaceutical Network published the Document on Centralized Drug Purchase in Alliance Area. This gathering and mining expansion will be carried out in 25 regions such as Shanxi, Inner Mongolia, Liaoning, Jilin, Heilongjiang, Jiangsu and Zhejiang, involving 25 winning products of the first batch of pilot projects. At the same time, new regulations of "multiple tenders" will be introduced.

According to the arrangement, this round of procurement will open in Shanghai on September 24. The declaration materials will be received at 8:30 in the morning, the declaration information will be submitted and made public by 10:00 in the morning, and the supply area will be confirmed at 2:00 in the afternoon. The results are expected to be available on that day.

As the scope of centralized drug procurement is gradually pushed forward to the whole country, it is conducive to further reduce drug prices and reduce the drug burden of patients in China.

New Licenses for Pharmaceutical Production

According to the Notice on the Entry of New Licenses such as Pharmaceutical Production License issued by the State Administration of Pharmaceutical Supervision, the new licenses such as Pharmaceutical Production License will be launched on September 1.

The new edition of Pharmaceutical Production License, Pharmaceutical Preparation License for Medical Institutions, Pharmaceutical Business License, Radioactive Drug Production License, Radioactive Drug Business License, Radioactive Drug Use License and Internet Pharmaceutical Information Service Qualification Certificate, which are unified by the State Pharmaceutical Administration, will be launched. Including original and duplicate certificates.

For licenses that have not yet expired in 2019, the provincial (district, city) drug administration shall organize the replacement of new licenses by the end of December 2020. The validity period is the same as that of the original license. If the certificate does not meet the requirements, it shall not be renewed.

Unqualified retail drugstores are not allowed to purchase paracetamol oxycodone tablets

According to the announcement on the inclusion of compound preparations containing oxycodone in the management of psychotropic drugs issued jointly by the State Administration of Pharmaceutical Administration and other three departments, from September 1, 2019, enterprises that do not possess the qualification for the management of psychotropic drugs of category II shall not buy oxycodone tablets of paracetamol, and the registration of the original inventory products shall be submitted to the relevant regions where they are located. After the Department has filed the record, it will be sold out according to the regulations.

At the same time, the manufacturers of oxycodone paracetamol tablets need to be equipped with storage conditions and safety management facilities in accordance with relevant requirements, formulate corresponding management system, and apply to the local provincial drug regulatory authorities for designated production formalities before January 1, 2020.

Compound preparations containing oxycodone are included in the management of psychotropic drugs

According to the regulations of the State Drug Administration and other three departments, on September 1, the products containing oxycodone will be officially listed in the management of psychotropic drugs.