2019 is the year of reform in the pharmaceutical industry. Now that August is coming to an end, every medical policy introduced in this month has a close relationship with the medical professionals, affecting all medical professionals. In this regard, the author combed the relevant policies issued by the Pharmaceutical and Biological Bank since August for the reference of the industry.

Notice on Expanding the Pilot Work of Medical Device Registrar System

According to the news of the State Drug Administration on August 1, the State Drug Administration issued the Notice on Expanding the Pilot Work of the Medical Device Registrar System, further expanding the pilot work of the Medical Device Registrar System, and further accumulating experience for the full implementation of the Medical Device Registrar System.

New Measures for Administration of Sample Inspection and Inspection of Drug Quality

On August 19, the State Administration of Pharmaceutical Supervision issued the Circular of the State Administration of Pharmaceutical Supervision on the Measures for the Administration of Publishing and Issuing Sample Inspection and Inspection of Drug Quality, in order to strengthen drug supervision and management and standardize the work of sample inspection and inspection of drug quality. The new "Drug Quality Sample Inspection and Inspection Management Measures" put forward new requirements for drug sampling, inspection, re-examination, supervision and management. Industry insiders said that the introduction of new management measures will play an important role in improving the quality of drugs.

Developing self-checking and self-correcting work for potential risks in drug production in Jiangxi

On August 13, Jiangxi Provincial Drug Regulatory Bureau issued the Notice on Self-checking and Self-Correcting the Risks of Drug Production and Implementing the Responsibility of Enterprises. According to the notification, Jiangxi will carry out self-checking and self-correcting work for potential risks in drug production throughout the province, and establish a regular reporting system for the implementation of the main responsibility. The self-checking scope includes pharmaceutical manufacturers (including Chinese herbal decoction pieces, excluding medical oxygen manufacturers), Chinese herbal extract manufacturers, and pharmacies of medical institutions.

The new edition of Pharmaceutical Production License will be launched

On August 7, the website of the State Pharmaceutical Regulatory Bureau issued a notice on the launch of new licenses such as Pharmaceutical Production License. According to the notification, the State Drug Regulatory and Administration Department has unified the formulation of license forms such as Pharmaceutical Production License. The new license format will be available from September 1, 2019.

To clarify the relationship between generic drug registration standards and Pharmacopoeia standards

In early August, the State Drug Administration issued a bulletin on the implementation of drug standards in the evaluation of the consistency of quality and efficacy of generic drugs (No. 62, 2019). The announcement clarifies the relationship between generic drug registration standards and national drug standards such as the Chinese Pharmacopoeia.

Jiangxi Province Adjusts Payment Standard of 42 Specialty Medical Insurance Drugs

According to the news of Jiangxi Medical Security Bureau in early August, due to the emergence of new national lowest prices for some medicines, according to the relevant regulations of special medicines management in medical insurance, the medical insurance payment standard for special medicines in Jiangxi Province has been lowered since September 1, 2019. The special medicines that adjust the payment standard of medical insurance are imitations of medicines negotiated by the state and medicines negotiated by Jiangxi province.

The National Essential Drug System has gradually landed in all parts of the country.

In August, the National Essential Drug System gradually landed throughout the country. For example, Liaoning has issued opinions on improving the implementation of the national essential drug system, clarifying the implementation of the national essential drug system in all levels of medical institutions in the province, requiring reform and improvement of the national statistical assessment methods for the allocation and use of essential drugs, and double-line statistical assessment of the proportion of the amount of allocation and the amount of purchase.

Gansu Province formulated and issued Implementation opinions, made it clear that all parts of the country strictly implemented the 2018 edition of the national essential drug catalogue, earnestly guaranteed production and supply, and relevant medical institutions were fully equipped with priority use; Yunnan issued Implementation Opinions on implementing the national essential drug system, and proposed improving the effective supply capacity of essential drugs and establishing and perfecting it. The management mechanism of access and withdrawal of successful and networked drugs should be established to give priority to the use of incentives; Guangdong Province jointly issued the "Opinions on the Implementation of the National Essential Drug System", which made it clear that all localities and relevant units should strictly implement the "National Essential Drug Catalogue (2018 edition)", and in principle no more drugs should be added.

In addition, Qinghai has issued Opinions on the Implementation of the National Essential Drug System, which calls for the full implementation of the Essential Drug Catalogue. On the basis of adhering to the dominant position of the National Essential Drug Catalogue, some Tibetan patent medicines are added as the supplementary essential medicines in our province to meet the needs of the people of all ethnic groups in the province.