Expert Q&A – media

【EXPERT Q&A】What is the reason that the FDA will terminate the regulations on animal trials of monoclonal antibodies?

Drugdu.com expert’s response: The U.S. Food and Drug Administration (FDA) plans to gradually terminate the requirement for animal testing of monoclonal antibodies, primarily based on the following aspects: I. Technological Advancements Offer Alternative Approaches Organoids and Organ-on-a-Chip Technology: These technologies can simulate the physiological functions of human organs, demonstrating high predictability in drug safety testing. For example, liver-on-a-chip models have achieved up to 87% accuracy in predicting drug-induced liver toxicity. Artificial Intelligence and Computational Models: By simulating drug absorption, distribution, metabolism, and excretion (ADME) in the human body, AI models can more accurately predict drug efficacy and toxicity, reducing reliance on animal experiments. Real-World Data: Leveraging existing real-world safety data from other countries to further validate drug performance in humans provides a more reliable basis for drug assessment. II. Limitations of Animal Experiments Species Differences: Animal models exhibit significant physiological and metabolic disparities from humans, making it difficult to extrapolate ...
- Source: drugdu
- 28
- April 28, 2025
【EXPERT Q&A】What is the effect of regorafenil tablets?

Drugdu.com expert’s response: Regorafenib tablets are multi-target tyrosine kinase inhibitors primarily used in the treatment of various solid tumors. They possess anti-angiogenic properties and can inhibit tumor cell proliferation and metastasis. Their specific efficacy includes: I. Treatment of Gastrointestinal Stromal Tumors (GIST) Patient Population: Patients with locally advanced, unresectable, or metastatic gastrointestinal stromal tumors who have experienced disease progression or intolerance after previous treatment with imatinib mesylate and sunitinib malate. Mechanism of Action: By inhibiting targets such as KIT, PDGFRα, RET, and VEGFR, it blocks signal transduction pathways in tumor cells, inhibiting tumor growth and angiogenesis. II. Treatment of Hepatocellular Carcinoma (HCC) Patient Population: Patients with hepatocellular carcinoma who have previously received sorafenib treatment. Mechanism of Action: Inhibits targets such as VEGFR, TIE2, PDGFR, and FGFR, reducing tumor angiogenesis and inhibiting tumor growth and spread. III. Treatment of Metastatic Colorectal Cancer (mCRC) Patient Population: Patients with metastatic colorectal cancer who ...
- Source: drugdu
- 40
- April 25, 2025
【EXPERT Q&A】What are the precautions for Chinese and Western medicine at sea?

Drugdu.com expert’s response: When Chinese traditional and Western medicines venture overseas, there are multiple aspects requiring attention, encompassing regulatory compliance, market access, intellectual property protection, and cultural difference management. Below is a detailed analysis: I. Regulatory and Compliance Aspects Target Market Regulations: It is essential to gain an in-depth understanding of the drug regulatory regulations in the target country or region, including requirements for registration, approval, clinical trials, and Good Manufacturing Practice (GMP) for production quality management. For example, the U.S. FDA mandates rigorous clinical trials before a drug can be marketed, while the EU EMA emphasizes compliance with GMP standards in the production process. Different countries have specific requirements for drug ingredients, labels, and instructions, necessitating compliance with local regulations. International Certifications and Standards: Obtaining international certifications (such as WHO prequalification, PIC/S GMP) can enhance product credibility and facilitate market access. Adhering to international quality standards (such as ISO, ICH guidelines) ensures product ...
- Source: drugdu
- 47
- April 23, 2025
【EXPERT Q&A】Medical devices have high requirements for the stability and safety of PCBA. What are the key control points in the development and production process?

Drugdu.com expert’s response: In the research, development, and production process of Printed Circuit Board Assembly (PCBA) for medical devices, stability and safety are core requirements. To ensure that products meet the high standards of the medical industry, strict controls must be implemented across multiple dimensions, including design, materials, manufacturing processes, testing, regulatory compliance, and supply chain management. The following is a detailed analysis of key control points: I. Design Phase Functional Safety Design Employ redundant design, fail-safe mechanisms, and fault-tolerant design to ensure that a single failure does not lead to system failure. Conduct risk analysis (e.g., FMEA, FTA) to identify potential failure modes and develop mitigation measures. Electromagnetic Compatibility (EMC) Design Optimize circuit layout to reduce electromagnetic interference (EMI) and radio frequency interference (RFI). Select low-emission components and incorporate shielding and filtering designs to ensure stable operation in complex electromagnetic environments. Thermal Design and Reliability Assessment Analyze key component ...
- Source: drugdu
- 74
- April 21, 2025
【EXPERT Q&A】What problems should domestic pharmaceutical and medical equipment enterprises pay attention to in export?

Drugdu.com expert’s response: When domestic pharmaceutical and medical device enterprises engage in foreign trade exports, they need to focus on core issues such as policy regulations, market demand, product quality, certification and compliance, and branding and after-sales service to ensure the smooth progress of export business. Below are specific considerations: I. Policy Regulations and Compliance Requirements Target Market Regulations Different countries have significantly varying regulatory standards for medical devices. For example, the EU requires compliance with CE certification and MDR regulations, while the US requires FDA 510(k) registration or PMA approval. Enterprises must understand the regulatory requirements of the target market in advance to avoid product rejection due to compliance issues. Domestic Export Policies Enterprises need to obtain medical device registration certificates and production licenses issued by the National Medical Products Administration (NMPA) and handle import-export business licenses. Special medical devices (such as COVID-19 testing reagents) may require additional export ...
- Source: drugdu
- 58
- April 18, 2025
【EXPERT Q&A】What are the procedures and qualifications required for the export of domestic drugs to East Africa?

Drugdu.com expert’s response: Export Process and Qualification Requirements for Chinese Pharmaceutical Products to East Africa (2025 Update) Based on the latest East African Community (EAC) pharmaceutical regulations and China’s White Paper on Medical Exports to Africa: I. Pre-Qualification Preparation (3–6 Months) Production Compliance: 2025 China GMP Certification: Mandatory adoption of quantum-encrypted traceability modules for data integrity. Submit 36-month stability test reports under tropical conditions (40°C/75% humidity). WHO Prequalification (PQ): Required for antimalarial/HIV drugs in EAC public tenders. Review周期缩短至4.2 months (30% faster than 2020). Export Documentation Free Sale Certificate (FSC): Issued by provincial authorities, apostilled, and blockchain-verified (recognized by Kenya Revenue Authority). Religious Compliance: Halal certification (EAC Islamic Affairs Council) for animal-derived ingredients; separate approval for alcohol-based formulations. II. EAC Regional Market Access Centralized EAC Review (Core Step) MRH-01 Dossier Submission: Include multi-country clinical trial data (minimum 2 EAC nations, e.g., Rwanda’s Kigali University Hospital). Localized bilingual packaging (English/Swahili + Braille). Fast-Track Eligibility: 50% faster review for drugs in the China-Africa Public ...
- Source: drugdu
- 85
- April 16, 2025
【EXPERT Q&A】Why is it difficult for generic drugs to reach the level of original drugs?

Drugdu.com expert’s response: The reasons why generic drugs often struggle to fully match the quality of brand-name (originator) drugs involve multiple aspects, primarily including differences in the research and development (R&D) process, manufacturing techniques, quality control, clinical trials, and patent/regulatory factors. Below is a detailed analysis: I. Differences in the R&D Process Lengthy R&D Timeline for Originator Drugs: Developing an originator drug from laboratory research to market approval typically takes 10–15 years and costs billions of dollars, involving rigorous clinical trials to verify safety and efficacy. Different R&D Pathway for Generic Drugs: Generic drugs do not need to replicate the pre-clinical studies or clinical trials of originator drugs; they only need to demonstrate bioequivalence (similar absorption rate and extent in the body). However, this “equivalence” does not equate to “identity,” and subtle differences may exist in drug metabolism and pharmacodynamics. II. Manufacturing Techniques and Quality Control Complexity of Manufacturing Processes: The ...
- Source: drugdu
- 85
- April 14, 2025
【EXPERT Q&A】Has stem cell therapy entered the clinical stage?

Drugdu.com expert’s response: Stem cell therapy has entered the clinical treatment stage and is continuously advancing globally, with multiple countries approving related therapies for specific diseases, while numerous clinical trials are underway to verify their safety and efficacy. I. Approved Stem Cell Therapies United States: In 2010, the FDA approved Prochymal® (allogeneic bone marrow mesenchymal stem cells) for the treatment of pediatric graft-versus-host disease (GvHD), marking the world’s first approved stem cell drug. European Union: In 2015, the EU approved Holoclar® (autologous limbal stem cells) for the treatment of severe limbal stem cell deficiency. Japan: In 2018, Japan approved Temcell® (allogeneic bone marrow mesenchymal stem cells) for the treatment of GvHD. South Korea: In 2022, South Korea approved Cartistem® (umbilical cord blood-derived mesenchymal stem cells) for the treatment of degenerative arthritis. China: In 2024, China’s National Medical Products Administration (NMPA) approved “Aimaituosai Injection” (human umbilical cord mesenchymal stem cell injection) ...
- Source: drugdu
- 88
- April 11, 2025
【EXPERT Q&A】Are generic drugs really worse than the original?

Drugdu.com expert’s response: Are generic drugs necessarily inferior to brand-name (originator) drugs? The specific differences depend on the quality level of the generic drugs. I. Core Differences Between Generic and Brand-Name Drugs 1. Research Foundation and Validation Brand-Name Drugs: Require foundational research, preclinical studies, multi-phase clinical trials (Phases I–III), and post-marketing surveillance (Phase IV) to verify safety, efficacy, and long-term impacts. Generic Drugs: Demonstrate bioequivalence to brand-name drugs in terms of absorption rate and extent through bioequivalence trials, without replicating the original clinical trials. 2. Quality Standards and Consistency Brand-Name Drugs: Utilize proprietary manufacturing processes and quality control systems, often involving patented technologies. Generic Drugs: Must pass consistency evaluations to ensure equivalence in active ingredients, dosage forms, and routes of administration to brand-name drugs, though excipients and manufacturing processes may differ. II. Quality Variations in Generic Drugs 1. High-Quality Generic Drugs Some generic drugs achieve efficacy and safety comparable to ...
- Source: drugdu
- 87
- April 9, 2025
Career Development Guide for API and Pharmaceutical Intermediate Sales Professionals

In the global pharmaceutical supply chain, sales professionals specializing in Active Pharmaceutical Ingredients (APIs) and pharmaceutical intermediates play a crucial role. To excel in this competitive and dynamic international market, continuous enhancement of skills and knowledge is essential. Here are some key strategies to advance your career in pharmaceutical foreign trade sales: 1. Deepen Product and Industry Knowledge A thorough understanding of the chemical properties, production processes, quality standards, and applications of the APIs and intermediates you sell is fundamental to building trust with clients. Staying informed about global pharmaceutical regulations, market trends, and policy changes enables you to make informed decisions in the international marketplace. For instance, being familiar with the “Guidelines for the Development of the Pharmaceutical Industry” can provide insights into industry directions. 2. Enhance Cross-Cultural Communication and Negotiation Skills Engaging with clients from diverse cultural backgrounds is a daily aspect of international sales. Understanding and respecting ...
- Source: drugdu
- 81
- April 8, 2025

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.