media – Page 43 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

【EXPERT Q&A】The US FDA has implemented a brand-new QMSR system regulation for medical devices. What significant changes will occur in the corresponding on-site inspections?

Drugdu.com expert’s response: The U.S. FDA’s new Quality Management System Regulation (QMSR) for medical devices marks a significant transformation in its regulatory framework and inspection logic. By integrating the ISO 13485:2016 international standard, QMSR drives a shift in quality management from “clause compliance” to “risk-driven” approaches, while strengthening lifecycle-wide compliance controls. Against this backdrop, FDA on-site inspections will undergo the following key changes: I. Evolution of Inspection Basis and Process 1. Regulatory Restructuring: QMSR incorporates ISO 13485:2016 in its entirety through “reference incorporation,” while retaining FDA-specific requirements (e.g., record retention language, certain reporting obligations). Inspections will be conducted based on “ISO 13485:2016 clauses + FDA additional requirements,” rather than the standalone clauses of the previous QSR. 2. Updated Inspection Manual: The FDA has abolished the long-standing Quality System Inspection Technique (QSIT) methodology and introduced the new Medical Device Manufacturer Inspection Compliance Program Manual (7382.850). This manual categorizes QMSR requirements into six quality ...
- Source: drugdu
- 138
- February 23, 2026
【EXPERT Q&A】How is a drug safety evaluation experiment conducted?

Drugdu.com expert’s response: Drug safety evaluation experiments require a systematic process that combines in vitro experiments, animal experiments, and clinical studies to comprehensively assess potential drug risks and ensure medication safety. Below are the specific experimental methods and procedures: I. Foundations of Experimental Design Research Objectives and Plan Clarify the drug’s intended use, target population, and core objectives (e.g., toxicity assessment, dose exploration). Develop a detailed protocol, including experimental design, animal species/quantity, and dosing duration. Conduct literature reviews to understand safety data for similar drugs and identify potential risk points. Selection of Experimental Models Animal Models: Choose mice, rats, dogs, or non-human primates based on drug characteristics. In Vitro Models: Utilize cell cultures, tissue chips, or computational simulations (e.g., PBPK models) to predict toxicity. Special Population Models: Design targeted experiments for children, pregnant women, etc. II. Core Experimental Methods 1. Acute Toxicity Experiments Objective: Evaluate toxic reactions following single or ...
- Source: drugdu
- 141
- February 20, 2026
Bulmedica

Organiser：Bulgarreklama Exhibition Group, Bulgaria Time：May 13 – 15, 2026 Address：147 Tsarigradsko Shosse 1784, Sofia Exhibition hall：Inter Expo Center Product range: Laboratory instruments, equipment, and technology; medical diagnostic technology, equipment, and products; basic medical construction supplies; hospital infrastructure; surgical instruments, equipment, and accessories; medical instruments, equipment, and devices; medical imaging equipment, etc. Internal medicine, dental equipment and materials; pharmaceuticals, pharmacology, drug and pharmaceutical sciences; orthopedic and ophthalmic equipment and materials; health and rehabilitation sciences, etc. Dental equipment and tools; dental raw materials and pharmaceuticals; dental laboratory technology, etc.; medical information technology; dental diagnostic instruments and consumables; infection control and maintenance; medical publications; medical teletherapy; medical software, etc. Ward furniture and equipment; hospital kitchen equipment; biochemical and laboratory testing equipment; hygiene materials; medical communication technology and equipment; comprehensive hospital information technology and services; electronic medical devices; hospital equipment; radiology; X-ray department; physiotherapy, etc. Biopharmaceuticals, traditional Chinese medicine, herbal medicine, etc.; pharmaceutical production ...
- Source: drugdu
- 148
- February 19, 2026
【EXPERT Q&A】How should we view the consistency between generic drugs and original research drugs?

Drugdu.com expert’s response: The consistency between generic drugs and originator drugs is a crucial issue in the pharmaceutical field, with its core lying in assessing whether generic drugs achieve equivalent levels in terms of quality, efficacy, and safety compared to originator drugs. This issue not only concerns patients’ rights to medication but also affects the balance between innovation and accessibility in the pharmaceutical industry. The following analysis unfolds from four dimensions: science, policy, economy, and society. I. Scientific Foundation: Technical Standards for Consistency Evaluation Pharmaceutical Equivalence：Generic drugs must be identical to originator drugs in terms of active ingredients, dosage forms, strengths, and routes of administration, and demonstrate consistency in physical and chemical properties through tests such as dissolution rate and content uniformity. This serves as the fundamental threshold for generic drug development. Bioequivalence (BE)：It is necessary to prove through human clinical trials or alternative methods (e.g., in vitro models) that ...
- Source: drugdu
- 530
- February 18, 2026
CPHI Middle East

Organiser：Informa Markets Time：May 11 – 13, 2026 Address：King Abdullah Rd, King Abdullah Dt., Riyadh 11564, Saudi Arabia Exhibition hall：Riyadh International Convention & Exhibition Center Product range: Active Pharmaceutical Ingredients (APIs): Vitamins, hormones, sulfonamides, antipyretic analgesics, tetracyclines, amino acids and their derivatives, chloramphenicols, digestive system drugs, other anti-infective agents, penicillins, aminoglycosides, lincomycins, cardiovascular system drugs, antiparasitic drugs, cephalosporins, macrolides, respiratory system drugs, central nervous system drugs, and other Western medicine raw materials. Pharmaceutical Machinery: Pharmaceutical machinery, packaging machinery, packaging materials, production equipment and technology for pharmaceuticals, pharmaceutical packaging equipment, pharmaceutical packaging materials, systems for pharmaceutical production, cleaning, disinfection, and laboratory instrumentation. Pharmaceutical Products: Various traditional Chinese patent medicines, Western medicines, new drugs,特效 drugs (special-effect drugs), various APIs, chemical pharmaceuticals, pharmaceutical intermediates, biopharmaceuticals, traditional medicines, Chinese herbal medicines, herbal extracts, animal and plant extracts, veterinary drugs, food ingredients and additives, etc. About CPHI Middle East： The CPhI Middle East in Riyadh, ...
- Source: drugdu
- 292
- February 17, 2026
【EXPERT Q&A】What should be noted when registering medical device products for the first time?

Drugdu.com expert’s response: I. Regulatory Framework and Product Classification 1. Clarify Regulatory Requirements Domestic Registration: Comply with China’s Medical Device Supervision and Administration Regulations, Medical Device Registration and Filing Measures, etc. Export Compliance: Meet target country/region standards (e.g., EU CE, U.S. FDA). Key Point: Regulations are frequently updated; track changes via the NMPA website or professional agencies. 2. Accurate Product Classification Classify risk levels per China’s Medical Device Classification Catalog: Class I (low risk), Class II (moderate risk), Class III (high risk). Registration processes vary significantly by class. Recommendation: Use the NMPA’s “Medical Device Classification Determination” system for uncertain cases. For innovative products, prepare for the “Special Approval Pathway for Innovative Medical Devices.” II. Technical Documentation and Testing 1. Prepare Complete Technical Files Product Technical Requirements (CTD): Detail performance metrics (e.g., filtration efficiency for surgical masks), testing methods, and structural composition. Ensure quantifiable, verifiable metrics aligned with national standards (e.g., GB, YY series). ...
- Source: drugdu
- 219
- February 16, 2026
Rising Star in Oral Weight Loss! Hengrui’s GLP 1R/GIPR Agonist Succeeds in Phase II Study

On February 10, 2026, Hengrui Pharmaceutical and Kailera Therapeutics (US) jointly announced positive top-line results from a Phase II clinical trial (NCT06841445) of Remputeptide Tablets (HRS9531), their investigational GLP 1/GIP dual receptor agonist, in Chinese adults with obesity. Data showed that at Week 26, mean body weight reduction in the highest dose group reached 12.1%, with no weight loss plateau observed. Up to 38.6% of participants achieved at least 15% weight loss, while the incidence of gastrointestinal adverse events was maintained at a low level. This breakthrough marks important progress in the global development of oral multi target weight loss drugs. With its convenient once daily oral administration and robust efficacy data, Remputeptide Tablets is expected to offer a new therapeutic option for patients with obesity that may surpass injectable formulations. It also adds a key competitive asset to Hengrui’s global strategic layout in metabolic diseases. 1 Remputeptide: Dual pathway ...
- Source: drugdu
- 404
- February 13, 2026
adjuvant therapy for breast cancer

On February 12, Daiichi Sankyo announced that its injectable detrastuzumab (Uroder®, DS-8201a, T-DXd) has been approved for inclusion in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of adult patients with HER2-positive breast cancer who still have residual invasive lesions after neoadjuvant anti-HER2 therapy. Detrastuzumab was developed by Daiichi Sankyo and co-developed by Daiichi Sankyo and AstraZeneca.A jointly developed HER2-targeting antibody-drug conjugate (ADC). https://finance.eastmoney.com/a/202602123648930874.html
- Source: drugdu
- 324
- February 13, 2026
The approval of telpopril monotherapy for type 2 diabetes has driven an upgrade in the management paradigm

　　According to this newspaper, in current clinical practice, the treatment of type 2 diabetes often relies heavily on the traditional approach of “gradually increasing medication.” Many patients only enter a more potent treatment phase after their blood sugar has been poorly controlled for a long time and the risk of complications has gradually accumulated. 　　However, in recent years, discussions surrounding early diabetes management have been undergoing a significant shift. A growing body of research suggests that the choice of treatment starting point not only affects short-term glycemic control but also profoundly relates to patients’ long-term complication risk and overall prognosis. Clinical management strategies for type 2 diabetes are shifting from a “late-stage reinforcement” approach to a new paradigm of “intervention at the starting point.” 　　February 11th, ReiThe innovative dual-target drug Mufengda® (Telborpeptide Injection) has been approved by the China National Medical Products Administration for monotherapy in adults with type 2 ...
- Source: drugdu
- 148
- February 13, 2026
Oral insulin launch fails; China Resources Pharmaceutical plans to sell Tianmai Biotechnology

On February 9, China Resources Pharmaceutical (03320.HK) issued an announcement on the Hong Kong Stock Exchange, stating that its wholly-owned subsidiary, China Resources Pharmaceutical Investment Co., Ltd., plans to sell its 17.87% stake in Hefei Tianmai Biotechnology Development Co., Ltd. (hereinafter referred to as “Tianmai Biotechnology”) through a public listing on the Shanghai United Assets and Equity Exchange, with a listing price of RMB 1.42 billion. Looking back at the history of cooperation between China Resources Pharmaceutical and Tianmai Biotechnology, their partnership began in 2016, when the number of diabetes patients in China continued to rise, leading to a surge in demand for insulin as a core treatment drug. At the same time, China Resources Pharmaceutical was also seeking to expand into the biopharmaceutical field. Against this backdrop, China Resources Pharmaceutical signed a strategic agreement in December 2016 to acquire a 20% stake in Tianmai Biotechnology, thus officially entering the ...
- Source: drugdu
- 140
- February 13, 2026

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