media – Page 132 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

【EXPERT Q&A】Is CE certification required for EU GPSR compliance? What are the conditions?

Drugdu.com expert’s response: The Relationship Between EU GPSR Compliance and CE Certification Mandatory Compliance with GPSR: GPSR (General Product Safety Regulation) is a regulation of the European Union aimed at ensuring that products sold on the market are safe and do not pose a harm to consumers. Compliance with GPSR regulations is mandatory for most products. Definition and Scope of CE Certification: CE certification is a product compliance mark indicating that a product meets the safety, health, and environmental protection requirements of the European Union. It primarily applies to certain specific categories of products, such as electronics and machinery. Relationship Between GPSR and CE Certification: GPSR compliance and CE certification are two different compliance systems, but they overlap in some aspects. The directives and standards upon which CE certification is based correspond to the safety requirements of GPSR, but their focuses and scopes of application differ. Not all products that need to ...
- Source: drugdu
- 355
- February 26, 2025
CMEF

Organiser：Reed Sinopharm Exhibitions Time：April 8th – 11th, 2025 Address：Shanghai National Convention and Exhibition Center Address: No. 333 Songze Avenue, Xujing Town, Qingpu District, Shanghai Exhibition hall：Shanghai National Convention and Exhibition Center Product range: Medical Imaging Area: Radiological products, ultrasound products, nuclear medicine products, molecular imaging, interventional products, etc. Operating Room Area: Hybrid operating rooms, integrated operating room solutions, surgical instruments, anesthesia machines, ventilators, monitors, operating room engineering, surgical lights, ceiling-mounted equipment booms, etc. In Vitro Diagnostics Area: Comprehensive laboratory solutions, clinical diagnostic equipment, diagnostic reagents, POCT (point-of-care testing), household diagnostic devices, etc. Rehabilitation and Physiotherapy Area: Rehabilitation equipment, assistive devices, traditional Chinese medicine treatments, physiotherapy equipment, medical high-frequency devices, etc. Orthopedics Zone: Orthopedic implants for joints, trauma, and spine; orthopedic surgical instruments and equipment; bone power tools, and other orthopedic-related products. Medical Informatization Area: System integrators, mobile healthcare, medical management, quality control, clinical hospital information management systems, IT equipment ...
- Source: drugdu
- 477
- February 25, 2025
HPV vaccine market is about to expand, and the Bio-Vaccine ETF (562860) rose 1.14% during the session

As of 10:13 on February 20, 2025, the CSI Vaccine and Biotechnology Index rose strongly by 1.13%, with constituent stocks Yifang Biotech rising by 7.45%, Dizhe Pharmaceuticals rising by 6.93%, Shuanglu Pharmaceuticals rising by 4.37%, and Wanze Shares, Dongbao Bio and other stocks following suit. Bio-Vaccine ETF (562860) rose by 1.14%, and the intraday turnover has reached 6.5605 million yuan. In terms of scale, the scale of Bio-Vaccine ETF has increased by 3.2427 million yuan in the past week, achieving significant growth. It is worth noting that the valuation of the CSI Vaccine and Biotechnology Index tracked by the fund is at a historical low, with the latest price-to-book ratio PB being 2.95 times, which is lower than the index’s 83.43% of the past five years, and the valuation cost-effectiveness is outstanding. Data shows that as of January 27, 2025, the top ten weighted stocks in the CSI Vaccine and ...
- Source: drugdu
- 285
- February 24, 2025
Over 1.2 billion US dollars! CSPC Pharmaceuticals ROR1 ADC reaches international licensing cooperation

On February 19, CSPC Pharmaceutical Group announced that its subsidiary CSPC Pharmaceutical Group Jushi Biopharmaceutical Co., Ltd. (hereinafter referred to as “Jushi Bio”) has reached an important agreement with Radiance Biopharma. According to the agreement, Radiance Biopharma will obtain the exclusive development and commercialization rights of Jushi Bio’s independently developed SYS6005 project in the United States, the European Union, the United Kingdom, Switzerland, Norway, Iceland, Liechtenstein, Albania, Montenegro, North Macedonia, Serbia, Australia and Canada. Jushi Bio will receive a down payment of US$15 million, a development and regulatory milestone amount of US$150 million, a sales milestone amount of US$1.075 billion, and a certain percentage of sales revenue. SYS6005: An innovative ADC drug SYS6005 is a monoclonal antibody-drug conjugate (ADC) independently developed by Jushi Bio. It can bind to specific receptors on the surface of tumors, enter cells through endocytosis and release toxins to kill tumor cells. SYS6005 uses Jushi Bio’s ...
- Source: drugdu
- 261
- February 24, 2025
Hengrui Medicine enters the children’s myopia track, this “myopia magic drug” is about to debut

Recently, Chengdu Shengdi Pharmaceutical, a subsidiary of Hengrui Medicine, submitted a marketing authorization application for HR19034 Eye Drops (Atropine Sulfate Eye Drops) to the National Medical Products Administration, which has been accepted. This product is mainly used to prevent and control the progression of myopia in children and adolescents. According to the Yaozhi Data global drug analysis system, Hengrui Medicine’s HR19034 project started clinical trials in April 2021. After completing the Phase I trial, the company immediately started Phase II/Phase III research. According to Hengrui’s announcement, the project will complete a three-year clinical trial in August 2024. Research data showed that HR19034 was superior to the control group in terms of the primary endpoint and demonstrated good safety and tolerability in children with myopia. The most common application of atropine in ophthalmology is mydriasis. Atropine sulfate at a concentration of 1% is usually used for fundus examination and eye examination ...
- Source: drugdu
- 339
- February 24, 2025
Pfizer’s pan-KRAS inhibitor cancer drug approved for clinical trials

On February 17, the CDE official website announced that Pfizer’s Class 1 new drug “PF-07934040 Tablets” has obtained implicit approval for clinical trials and is intended to be developed to treat advanced solid tumors carrying KRAS mutations. PF-07934040 is a pan-KRAS inhibitor under development and is currently undergoing Phase 1 clinical trials internationally. According to Yaozhi data, this is the first time that the product has been approved for IND in China. According to Pfizer’s official website, PF-07934040 is a pan-KRAS “ON/OFF” inhibitor that has activity against wild-type (wt) KRAS and major mutant subtypes, and is inactive against NRAS or HRAS. PF-07934040 has been shown to bind to both the OFF (GDP-bound) and ON (GTP-loaded) states of KRAS wt, and has very low binding affinity to mutants, with a selectivity for binding to KRAS that is 5,000 times higher than HRAS/NRAS. https://news.yaozh.com/archive/45010.html
- Source: drugdu
- 412
- February 24, 2025
【EXPERT Q&A】What is the European Medical Device Naming System EMDN?

Drugdu.com expert’s response: The European Medical Device Nomenclature (EMDN) is a naming system established by the European Commission to support the operation of the European Database on Medical Devices (EUDAMED). Below is a detailed introduction to EMDN: I. Background and Purpose Background: In accordance with Article 26 of the Medical Devices Regulation (MDR) (2017/745) and Article 23 of the In Vitro Diagnostic Medical Devices Regulation (IVDR) (2017/746), the European Commission decided to establish the EMDN system. Purpose: EMDN aims to support the regulatory requirements of MDR and IVDR, including the preparation of device and technical documentation, sampling audits of technical documentation by notified bodies, post-market surveillance, vigilance, and post-market data analysis. It also provides patients with key descriptions of medical devices that have been marketed and registered in EUDAMED. II. Structure and Composition Structure: The alphanumeric structure of EMDN is based on a seven-level hierarchy, but typically, a simplified three-level ...
- Source: drugdu
- 334
- February 24, 2025
First Pharmaceutical plans to increase the guarantee limit for its loss making subsidiary

Recently, the “time-honored” pharmaceutical distribution enterprise in Shanghai, First Pharmaceutical (600833. SH), announced the expected guarantee amount for its wholly-owned subsidiary in 2025. To support the operation and development of its wholly-owned subsidiaries, First Pharma plans to provide an additional guarantee limit of no more than RMB 210 million for three wholly-owned subsidiaries: First Pharma (Hong Kong) Limited (hereinafter referred to as “First Pharma Hong Kong”), Shanghai HSBC Pharmaceutical Materials Co., Ltd. (hereinafter referred to as “HSBC Pharma”), and Shanghai First Pharmaceutical Store Chain Operation Co., Ltd. (hereinafter referred to as “First Pharma Chain”). The above matters will be submitted to the shareholders’ meeting for deliberation on February 27, 2025. According to the arrangement, the newly added guarantee amounts for Yiyi Hong Kong, HSBC Pharmaceuticals, and Yiyi Chain are 60 million yuan, 100 million yuan, and 50 million yuan respectively, accounting for 20.97% of the latest net assets of ...
- Source: drugdu
- 201
- February 22, 2025
supports the introduction of original drugs for domestic production; National Healthcare Security Administration

NO.1 National Medical Products Administration: Support the introduction of original drugs for domestic production On February 20, according to the WeChat official account of the State Food and Drug Administration, Huang Guo, the deputy director of the State Food and Drug Administration, recently led a team to Shandong for research. Huang Guo emphasized that the National Medical Products Administration attaches great importance to the research and development of innovative drugs and external cooperation. The drug regulatory authorities will further optimize the review and approval process, support the introduction of original drugs for domestic production, and enhance the confidence of multinational enterprises in investing and developing in China; At the same time, relevant policies will be continuously improved to support and guide domestic enterprises, research and development institutions, etc. to increase the research and development of innovative drugs and high-quality generic drugs, and actively participate in competition in both domestic and ...
- Source: drugdu
- 223
- February 22, 2025
Two innovative medical devices have recently been approved

Recently, the National Medical Products Administration approved registration applications for two innovative medical devices, namely: the percutaneous glomerular filtration rate measurement device from Meidekang Company (hereinafter referred to as Meidekang) and the disposable balloon cryoablation catheter from Xinuopu Medical Technology (Beijing) Co., Ltd. (hereinafter referred to as Xinuopu Medical). Meidekang: Combination of medicine and equipment to meet clinical needs MediBeacon was founded in 2012 and is dedicated to the research and development of medical optical diagnostic products, mainly involving fluorescent contrast agents and corresponding equipment. In 2019, East China Pharmaceutical invested 30 million dollars in Medecin, and obtained the exclusive commercialization rights of all Medecin products (including the follow-up development of new products) in 25 Asian countries or regions, including Chinese Mainland, Hong Kong, Taiwan, Singapore, and Malaysia, so as to layout the field of renal function monitoring. The approved percutaneous glomerular filtration rate measurement device – MediBeacon ® The ...
- Source: drugdu
- 182
- February 22, 2025

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