media – Page 23 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

【EXPERT Q&A】What is the Unique Device Identifier (UDI) for medical devices?

Drugdu.com expert’s response: The Unique Device Identifier (UDI) is a core tool in the international regulatory landscape for medical devices, designed to enable precise traceability and management throughout the entire lifecycle of medical devices via standardized coding. Its core components, implementation logic, and value are outlined below: I. UDI Composition: Dual-Code Synergy for Precise Identification The UDI consists of two parts—the Device Identifier (DI) and the Production Identifier (PI)—forming a “static + dynamic” dual-recognition system: Device Identifier (DI): Serves as the foundational identity code for medical devices, encompassing registrant/filing entity information, model specifications, and packaging hierarchy. For example, the DI of a specific brand of cardiac stent uniquely identifies its manufacturer, product model, and packaging format (e.g., single unit or boxed). The DI remains stable once assigned, ensuring traceability of basic product information. Production Identifier (PI): Acts as the dynamic information code for medical devices, covering production batch numbers, serial numbers, manufacturing ...
- Source: drugdu
- 149
- October 27, 2025
TSL2109 capsules approved for clinical trials

recently announced that its wholly-owned subsidiary, Jiangsu Tasly Diyi Pharmaceutical Co., Ltd., received the “Notice of Approval for Clinical Trial of Drugs” from the National Medical Products Administration (NMPA) for TSL2109 Capsules for the treatment of advanced solid tumors. TSL2109 Capsules, jointly developed by Jiangsu Diyi and China Pharmaceutical University, is a novel dual-target small molecule inhibitor. It selectively inhibits the downstream signaling pathways of both targets, arrests the tumor cell cycle, and induces apoptosis, achieving a synergistic killing effect. Currently, no similar dual-target drugs have entered clinical trials outside of China . As a traditional pharmaceutical company specializing in traditional Chinese medicine and chemical drugs, Tasly has been actively transforming its focus into innovative drugs in recent years. TSL2109 Capsule is a dual-target small molecule inhibitor with a novel structure, a first of its kind globally. However, investors should be aware of the high risks of drug development. Source: https://wap.eastmoney.com/a/202509243522600041.html
- Source: drugdu
- 166
- October 26, 2025
Salubris’s clinical trial application for SAL0137 has been accepted

On the evening of October 15, Xinlitai(002294) issued an announcement stating that the company received an acceptance notice approved and issued by the National Medical Products Administration, and the clinical trial application of the company’s independently developed innovative small molecule drug SAL0137 tablets (project code: SAL0137) was accepted. Xinlitai said that SAL0137 is a product developed by the company with independent intellectual property rights.The company’s application for SAL0137, an oral small molecule drug, is for clinical trials for the treatment of elevated lipoprotein (a). https://finance.eastmoney.com/a/202510153535045923.html
- Source: drugdu
- 133
- October 26, 2025
【EXPERT Q&A】Is it mandatory to have a stability test protocol and report for stress testing during the pharmaceutical R&D process?

Drugdu.com expert’s response Yes, stability test protocols and reports are mandatory for stress testing in the pharmaceutical R&D process. The reasons are as follows: I. Regulatory Requirements Consistency in International and Domestic Regulations: Whether it is China’s NMPA, the U.S. FDA, or the international ICH guidelines, all explicitly mandate that stress testing must be conducted for active pharmaceutical ingredients (APIs), accompanied by comprehensive stability test protocols and reports. These documents are essential prerequisites for drug marketing authorization, and their absence will directly result in application rejection. Essential Materials for Marketing Authorization: Stability test protocols and reports constitute core documentation for drug registration submissions. Regulatory authorities review these files to assess the quality controllability and safety of pharmaceutical products. II. Logical Imperatives in R&D Guiding Subsequent R&D Stages: Stability test protocols meticulously document critical information such as test methods, conditions, and sampling points, providing a foundation for subsequent accelerated and long-term ...
- Source: drugdu
- 139
- October 24, 2025
Simem 2026

Organiser：Algerian Ministry of Health, Algerian Healthcare Reform and Development Commission Time：April 8th -11th, 2025 Address：Les Genets, Chemin de Wilaya, Route 75, Oran, Algeria Exhibition hall：Centre des Conventions d’Oran Product range: Medical Equipment: Medical technology equipment, laboratory instruments and equipment, medical electronic equipment, medical diagnostic equipment, ophthalmic equipment and protective products, surgical instruments, emergency response equipment, hospital, dental, and medical facilities, dental service equipment, disposable medical products for hospitals and households, hospital and dental medical data processing systems, orthodontic and reconstructive equipment. Pharmaceuticals: Foreign prescription drugs, herbal preparations, nutritional health supplements such as minerals and vitamins, dietary nutrition products, homeopathic preparations, dermatological preparations, maternal and child healthcare products and infant food, personal hygiene products, incontinence products, medical consumables, etc. About Simem 2026： The Algerian International Medical Equipment Exhibition (SIMEM) is the most renowned medical equipment exhibition in Algeria. It is the only specialized exhibition for medical devices, pharmaceuticals, and dentistry in ...
- Source: drugdu
- 166
- October 23, 2025
【EXPERT Q&A】What are the requirements for applying to operate Class II medical devices?

Drugdu.com expert’s response: The application for a Class II medical device operating license must meet key requirements across four dimensions: enterprise qualifications, personnel allocation, facility conditions, and quality management systems. I. Enterprise Legal Qualifications Legal Person Status The applicant must possess valid legal person status, and the enterprise must be registered with the industrial and commercial authorities and hold a valid business license. Registered Capital and Scale The registered capital shall generally be no less than RMB 1 million (specific amounts may vary by regional policies and should comply with local requirements). The enterprise scale must align with its business scope to ensure capacity for fulfilling corresponding responsibilities. Registered Address and Premises The registered address must be an independent business venue with a floor area of no less than 80 square meters, separate from the residential address. The operating premises must comply with national laws and regulations, providing adequate space for storing medical ...
- Source: drugdu
- 150
- October 22, 2025
CPhI Japan 2026

Organiser: Informa Markets Time: April 21 – 23, 2026 Address: Tokyo Big Sight International Exhibition Center, 3-21-1 Ariake, Koto-ku, Tokyo 135-0063, Japan Exhibition hall: Tokyo Big Sight International Exhibition Center Product range: Active Pharmaceutical Ingredients (APIs): Vitamins, Hormones, Sulfonamides, Antipyretics and Analgesics, Tetracyclines, Amino Acids and Derivatives, Chloramphenicols, Gastrointestinal Medications, Other Antiinfectives, Penicillins, Aminoglycosides, Lincomycins, Cardiovascular Medications, Antiparasitic Drugs, Cephalosporins, Macrolides, Respiratory Medications, Central Nervous System Medications, Other Pharmaceutical Raw Materials Excipients & Dosage Forms: Excipients, Glidants, Enteric Coatings, Antioxidants, Sweeteners, Penetration Enhancers, Preservatives, Disintegrants, Coating Materials, Surfactants, Opacifiers, Flavors, Filter Aids, Stabilizers, Lubricants, Plasticizers, Solvents, Taste Masking Agents, Colorants, Clarifiers, pH Adjusters, Others Natural Extracts: Plant Extracts, Animal Extracts, Traditional Chinese Medicine Ingredients, Functional Food Ingredients, Health Supplement Ingredients, Nutritional Health Ingredients, Supplements, Dietary Fibers, Cosmetic Ingredients Biological Products & Reagents: Antibodies, Nucleic Acid/Protein Synthesis, Vectors & Constructs, Cellular Biology Assays, Animal/Plant Proteins/Antigens/Peptides, Nucleic Acid Analysis, Libraries & Constructs, Biochemistry, Standards/Controls, Protein Detection, Nucleic Acid Testing, Cloning ...
- Source: drugdu
- 147
- October 20, 2025
【EXPERT Q&A】What are the functions and roles of a ventilator?

Drugdu.com expert’s response: A ventilator is a medical device capable of replacing, controlling, or modifying a patient’s spontaneous breathing movements, providing mechanical ventilation support. Its core function is to maintain effective gas exchange, ensuring oxygen supply and carbon dioxide removal while reducing the workload on respiratory muscles. Below are the key functions and roles of ventilators: I. Core Functions Ventilation Support Replacing Spontaneous Breathing: When respiratory failure occurs due to disease, trauma, or anesthesia, ventilators can fully or partially replace pulmonary ventilation to ensure gas exchange. Adjusting Respiratory Parameters: By setting parameters such as tidal volume (air volume per breath), respiratory rate, and inspiratory-to-expiratory ratio, ventilators precisely control ventilation volume to avoid hyperventilation or hypoventilation. Oxygenation Support Increasing Blood Oxygen Levels: By delivering high concentrations of oxygen (adjustable FiO₂), ventilators correct hypoxemia (e.g., in pneumonia, ARDS, or cardiogenic pulmonary edema). Positive Pressure Ventilation: Utilizing airway positive pressure (e.g., CPAP, BiPAP ...
- Source: drugdu
- 159
- October 20, 2025
Sugemalimab receives positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use

On the morning of October 17, CStone Pharmaceuticals announced on the Hong Kong Stock Exchange that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion, recommending the approval of sugemalimab monotherapy for the treatment of adult patients with unresectable stage III non-small cell lung cancer (NSCLC) whose tumor cells express PD-L1 ≥1%, have no epidermal growth factor receptor (EGFR)-sensitive mutations or ALK or ROS1 genomic alterations, and have not progressed after platinum-containing chemoradiotherapy (CRT). https://finance.eastmoney.com/a/202510173536614458.html
- Source: drugdu
- 86
- October 18, 2025
Buchang Pharmaceutical’s subsidiary partners with WuXi AppTec to expand preclinical drug research with a contract exceeding 10 million yuan

On October 16, Buchang Pharmaceutical(603858) announced that its controlling subsidiary Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. and Suzhou WuXi AppTecNew Drug Development Co., Ltd. signed a “Technical Service Contract” with Luzhou Buchang Pharmaceutical Co., Ltd. The total contract amount is RMB 10.8 million, including 6% tax. Luzhou Buchang will pay the relevant fees in installments as agreed in the contract. The collaboration aims to entrust WuXi AppTec to conduct pharmacokinetic and toxicology testing projects, which is expected to help expand the company’s drug research and development capabilities and scope, and save clinical trial time and costs. As of December 31, 2024, Luzhou Buchang’s total assets were 2.223 billion yuan, total liabilities were 2 billion yuan, and net assets were 223 million yuan. In 2024, it achieved operating income of 47,100 yuan and a net profit of -16.24 million yuan. By June 30, 2025, total assets will rise to 2.34 billion ...
- Source: drugdu
- 78
- October 18, 2025

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