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【EXPERT Q&A】What is the role of the Drug Administration Act in ensuring the quality and safety of drugs?

Drugdu.com expert’s response: The “Pharmaceutical Administration Law of the People’s Republic of China” plays a crucial role in ensuring the quality and safety of drugs. Here are several key aspects of its role in this regard: Ⅰ. Defining and Classifying Drugs Article 2 of the Pharmaceutical Administration Law clearly stipulates that the drugs referred to in this Law are substances used for the prevention, treatment, and diagnosis of human diseases, for the purposeful regulation of human physiological functions, and with specified indications or functional indications, usage, and dosage, including traditional Chinese medicines, chemical drugs, and biological products. This definition clarifies the scope and classification of drugs, providing a legal foundation for subsequent regulatory work. Ⅱ. Establishing Strict Regulations for Drug Research and Development, Production, Operation, and Use Research and Development: Article 29 of the Pharmaceutical Administration Law stipulates that the research and development of new drugs must be conducted in accordance ...
- Source: drugdu
- 101
- October 25, 2024
Baiyu Pharmaceutical announces exclusive licensing agreement with Novartis for a small molecule anti-tumor drug

On October 17th, Baiyu Pharmaceutical announced an exclusive licensing agreement with Novartis for a small molecule anti-tumor drug. According to the agreement, Baiyu will receive a down payment of 70 million US dollars (approximately 499 million yuan), as well as various milestone payments and corresponding royalties for development, registration, and commercialization up to 1.1 billion US dollars (approximately 7.8 billion yuan). Novartis will obtain exclusive global development and commercialization rights for this small molecule innovative drug. Founded in 2005, Baiyu Pharmaceutical is headquartered in Chengdu, Sichuan. It is a global pharmaceutical enterprise with innovative drugs as its core, integrating research and development, production, sales, and traditional Chinese medicine cultivation into a full industry chain group. 10 pipelines under research, 5 tumor pipelines According to the announcement, the asset of this transaction is a small molecule innovative drug for the treatment of malignant tumors invented and discovered by the Baiyu Innovative ...
- Source: drugdu
- 77
- October 25, 2024
Medical device giant welcomes new head of China region

On October 21st, Omron Health Medical (China) Co., Ltd. (hereinafter referred to as Omron Health Medical) officially announced the appointment of Chen Xixiao as the Managing Director. After taking office, Chen Xiaoxiao will be fully responsible for the business development and strategic planning of Omron’s healthcare business in China, deepening Omron’s strategic layout in China, continuously enhancing the brand’s influence in the Chinese market, and solidly moving towards the beautiful vision of “Going for ZERO Preventive Medicine, Making the World Healthier”. The new helmsman takes office Omron Group was founded in 1933 by Lishi Yizhen and is a globally renowned manufacturer of automation control and electronic equipment, with expertise in sensing and control core technologies. By continuously creating new social demands, Omron Group has over 28000 employees worldwide and a turnover of 818.8 billion yen. The products cover a wide range of fields such as industrial automation control systems, electronic ...
- Source: drugdu
- 90
- October 25, 2024
Interfering in the procurement of medical equipment, many leaders fell from power

On October 21, the Hunan Provincial Commission for Discipline Inspection and Supervision reported 10 typical cases of corruption in the bidding field, including the intervention and intervention of Yin Yuying, former Party Secretary and Chairman of the Huaihua Municipal CPPCC, in medical equipment procurement projects. From 2015 to 2023, Yin Yuying used his position to greet the head of a hospital, and the hospital set the bidding threshold, informed a private business owner of the procurement brand information in advance, and provided assistance to him in undertaking a hospital’s medical distribution project and large-aperture CT equipment procurement project, and accepted huge amounts of money and property from him. Yin Yuying also had other serious violations of discipline and law, and has been expelled from the party and removed from public office. His suspected crimes have been transferred to the procuratorate for review and prosecution in accordance with the law. On ...
- Source: drugdu
- 89
- October 25, 2024
Interfering in the procurement of medical equipment, many leaders fell from power

On October 21, the Hunan Provincial Commission for Discipline Inspection and Supervision reported 10 typical cases of corruption in the bidding field, including the intervention and intervention of Yin Yuying, former Party Secretary and Chairman of the Huaihua Municipal CPPCC, in medical equipment procurement projects. From 2015 to 2023, Yin Yuying used his position to greet the head of a hospital, and the hospital set the bidding threshold, informed a private business owner of the procurement brand information in advance, and provided assistance to him in undertaking a hospital’s medical distribution project and large-aperture CT equipment procurement project, and accepted huge amounts of money and property from him. Yin Yuying also had other serious violations of discipline and law, and has been expelled from the party and removed from public office. His suspected crimes have been transferred to the procuratorate for review and prosecution in accordance with the law. On ...
- Source: drugdu
- 66
- October 25, 2024
A strong alliance! Bluesail Medical joins hands with Wanhua Chemical to welcome major opportunities and benefits

In the fields of medicine, scientific research, manufacturing, etc., professional-grade disposable consumables often play a pivotal role. These seemingly simple but crucial products not only bear the heavy responsibility of ensuring safety and improving efficiency, but also require the deep integration of cutting-edge technological innovation and practical applications, which also makes the research and development of high-end disposable consumables a complex and sophisticated system engineering. However, technological innovation does not exist in isolation. It must be rooted in actual needs and requires strong alliances between powerful companies. Now, this practice has another typical example of cooperation. Recently, Bluesail Medical and Wanhua Chemical signed a strategic cooperation agreement at Wanhua Chemical’s Cishan headquarters and held a joint innovation laboratory unveiling ceremony. The content of this cooperation is mainly for both parties to give full play to their strengths and carry out deep integration, namely “Wanhua Chemical’s polyurethane industry chain advantages and ...
- Source: drugdu
- 114
- October 25, 2024
Everest Medicines Announces Taiwan’s Approval of the World’s First New Drug Application for Nervosa® for the Treatment of IgA Nephropathy

Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on the research and development, clinical development, manufacturing and commercialization of innovative drugs, announced today that the Taiwan Food and Drug Administration (TFDA) has approved NEFECON® (budesonide enteric-coated capsules, NEFECON®) for the treatment of adult patients with primary immunoglobulin A nephropathy (IgA nephropathy) at risk of progression to delay renal function decline by 1, with no baseline proteinuria level restriction. This means that NEFECON®, as the world’s first and only causal treatment for IgA nephropathy fully approved by the U.S. Food and Drug Administration (FDA), has further expanded its coverage, bringing new hope to more Chinese IgA nephropathy patients. The results of the NefIgArd Phase 3 global clinical trial showed that compared with placebo, NefIgArd® not only brought about a lasting decrease in proteinuria and reduced the risk of microscopic hematuria, but more importantly, it showed clinically relevant and statistically significant treatment ...
- Source: drugdu
- 84
- October 25, 2024
AI+drug target discovery | Insitro and Eli Lilly reach strategic agreement to jointly promote new therapies for metabolic diseases

Zhiyao Bang October 23, 2024 09:01 Shanghai On October 9, 2024, insitro, a new drug development company that supports machine learning, announced the signing of three strategic agreements with Eli Lilly, focusing on developing potential new drugs for the treatment of metabolic diseases, including metabolic dysfunction associated fatty liver (MASLD), based on the targets identified by insitro using the company’s AI based platform.Metabolic diseases, including MASLD, affect millions of people worldwide, but effective treatment options are still limited. The current treatment mainly treats the symptoms rather than the root cause. This collaboration aims to combine Insitro’s machine learning platform with Lilly’s expertise in cutting-edge drug delivery and metabolic disease biology to change existing models. According to the first two agreements, Insitro can choose to license Lilly’s proprietary, clinically advanced ternary N-acetylglucosamine (GalNAc) delivery technology, which will be combined with two different small interfering RNA (siRNA) molecules discovered and developed by ...
- Source: drugdu
- 113
- October 24, 2024
GE Healthcare launches its first CT production line in the country

Recently, GE Healthcare launched its first CT production line in France, marking a significant expansion of the company’s business at its Booker factory in the Yvelines department of France. It is reported that the new production line was announced in 2023 with the aim of improving the company’s agility, reducing carbon emissions, and better serving European customers. At present, the first scanner assembled in France, the Revolution Maxima CT, has been installed in the emergency department of Montargis Hospital Center in Loiret. The assembly of Revolution Maxima CT at Buc factory includes all functions and X-ray testing, system configuration, and direct delivery to European customers, which helps simplify the supply chain. It is understood that the new production line is part of GE Healthcare’s “In Europe for Europe” program, which is expected to reduce carbon emissions related to scanner transportation in Europe by 84%. This reduction is mainly due to ...
- Source: drugdu
- 86
- October 24, 2024
Boston Scientific’s’ 2 Medical Devices’ Approved for Market by FDA

On October 21st, according to foreign media Fierce Biotech, the FARAWAVE NAV ablation catheter and Faraview software integrated with Boston Scientific’s navigation function have been approved by the US Food and Drug Administration (FDA). It is reported that the above two products have been officially launched in the United States, forming part of the Boston Scientific Farapulse Pulsed Field Ablation (PFA) system, providing a new visualization solution for cardiac ablation surgery. New features added The FARAWAVE NAV ablation catheter is an upgrade based on the previous generation PFA product FARAPULSE. It looks very similar to the FARAPULSE ablation catheter in appearance, but the new generation product has many new features that were not present in the previous generation product – magnetic navigation function and equipped with a dedicated 3D FARAVIEW module (software). Therefore, this also enables the FARAWAVE NAV ablation catheter to have both ablation and mapping functions:  Ablation ...
- Source: drugdu
- 93
- October 24, 2024

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