The first anniversary of the implementation of the "Hong Kong and Macao Pharmaceuticals" expansion will benefit more than a thousand people

Text/Yangcheng Evening News reporter Chen Zeyun Correspondent Guangdong Medicine Supervision

"I heard that there was this lipid -lowering medicine in Hong Kong before. I always hope that the hospital in Shenzhen can be introduced. Now it can be used at the door of the house. It is really convenient." Recently, Ms. Yu, a lady in Shenzhen citizens with diabetes and hyperlipidemia. At the University of Hong Kong, the Shenzhen Hospital of Hong Kong received an injection of imported lipid -lowering drugs. This imported drug, known as the "blood lipid vaccine" through the "Hong Kong and Macau Pharmaceuticals" channel, finally introduced it from Hong Kong to the mainland pilot hospital.

On August 27, 2021, the highly anticipated "Hong Kong and Macao Pharmaceuticals" policy was officially expanded in the 9 cities in the Mainland of the Guangdong -Hong Kong -Macao Greater Bay Area. Over the past year, the Guangdong Provincial Drug Administration (hereinafter referred to as the Provincial Drug Administration) has accelerated the exploration of new models of pharmaceutical and device cooperation with Hong Kong and Macao, which has brought higher levels and better medical services to the Guangdong -Hong Kong -Macao Greater Bay Area and even the people across the country. Essence The latest data show that the Provincial Pharmaceutical Regulatory Bureau has approved the in urgent need to import 20 Hong Kong and Macao drugs (a total of 35 batches) and 12 medical devices (a total of 14 batches) in the Mainland, which is more than 1054.

Covering 5 pilot hospitals involved multiple anti -tumor drugs

As of now, there are 5 medical institutions in the "Hong Kong and Macao Pharmaceuticals" policy, covering four cities in Guangzhou, Shenzhen, Zhuhai and Zhongshan.

The Provincial Pharmaceutical Regulatory Bureau has approved the in urgent need of 20 Hong Kong and Macao drugs in the Mainland (35 batches) and 12 medical devices (a total of 14 batches). Among them, 8 varieties of the Chinese Communist Party are antitumor drugs, and the remaining varieties include anti -immunotherapy drugs, rare diseases, acute treatment drugs and chronic diseases; , Symptom diagnostic reagents.

More and more patients who have not been treated in the past have not been treated, and now they have used clinically urgently needed Hong Kong and Macao pharmaceutical equipment to return to normal life. The "Hong Kong and Macao Pharmaceuticals" policy has opened up the channel for innovative medicines to enter the Mainland quickly, providing new possibilities for the people's various medical needs, and effectively enhance the happiness of beneficiated patients and their families.

In order to further and orderly expand the urgent need of innovative drugs, the Provincial Drug Administration will also cooperate with the Provincial Health Commission to appropriately expand the designated medical institutions to expand the pilot scope of "Hong Kong and Macao Pharmaceuticals". There are good medicines available, and it must be used by the people. Due to the expensive price of drugs in clinical urgent need to import and use, the patient's economic burden is relatively heavy, the Provincial Drug Administration is actively coordinating the medical insurance department to promote the exploration of commercial insurance payment.

Thousands of experts were included in the review expert library

In order to effectively supervise the "safety gate" of the life and health of patients with the health of patients, the Provincial Pharmaceutical Regulatory Bureau strictly supervises from the four aspects of import control, operating specifications, use management, and daily supervision. Imported medicines must be applied in the clinical application of Hong Kong and Macao and have been strictly reviewed by experts, which meets the requirements of safety, effectiveness, and advancedness.

In addition, the Provincial Pharmaceutical Supervision Bureau also took the lead in establishing a full -process supervision mechanism and regulatory traceability system. For all drugs and medical equipment, the code management was managed in accordance with the "one item, one yard" method, and realized that the clinical medical device of the Guangdong -Hong Kong -Macao Greater Bay Area was urgently needed to import drug medical equipment. The source is traceable, the direction is chasing, the use can be controlled, and the responsibility can be investigated.

Building a professional team is also a key part. 1423 experts involved in hospital management, adverse reactions, pharmaceutical management, laws and regulations, and many aspects have been included in the "Hong Kong and Macao Pharmaceuticals" review expert library to contribute professional forces to the supervision and innovation of medical device supervision of the Guangdong -Hong Kong -Macao Greater Bay Area.

Driven by the Provincial Pharmaceutical Regulatory Bureau, the Real World Research Institute of the Guangdong -Hong Kong -Macao Greater Bay Area of ​​Jinan University has been officially established on June 25 this year. The next step will actively carry out the analysis of clinical application data to promote the "Hong Kong and Macao medicine equipment "Tong" Real World Research Work.

Optimize approval policy to build a "Health Bay Area"

Due to the differences in the Guangdong -Hong Kong -Macao medical system, the cooperation between the three places in the innovation of medicines in the three places is very limited. The Provincial Pharmaceutical Regulatory Bureau highlights market -oriented, and through simplifying the application materials and rapid approval, more Hong Kong and Macao need drugs to reach medical institutions as soon as possible to press the "acceleration key" for the construction of the health bay area.

The Provincial Pharmaceutical Regulatory Bureau gives full play to the advantages of the frontiers of reform and opening up, and promoted the construction of the Guangdong -Hong Kong -Macao Greater Bay Area drug medical device supervision and innovation approval system. The system covers four matters such as clinical urgently needed to import pharmaceutical medical devices in the Guangdong -Hong Kong -Macao Greater Bay Area, so that safe and effective innovative medical products are more convenient to use the designated medical institutions in the Mainland in the Guangdong -Hong Kong -Macao Greater Bay Area.

On June 20, 2022, the "Declaration Guide to the Declaration of Medical Institution in the Guangdong -Hong Kong -Macao Greater Bay Area in the Mainland in the Guangdong -Hong Kong -Macao Greater Bay Area was officially released for the first time, and the application for approval was officially released. Among them, designated medical institutions to declare the approval of the approval of the institutional pharmaceutical medical device commitment approval time limit is only one working day; the specified medical institution declaration has been included in the catalog approval time of the catalog is 10 working days, and the application that has been included in the directory of the directory is included in the directory of the directory. The time limit for the promise approval is 15 working days. In terms of the first application approval time limit, the average shortened time limit reached 56%.

Source | Yangcheng Evening News • Yangcheng School

Responsible editor | Pan Liang

School pair | He Qiyun

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