Expert Q&A – Page 3 – media

【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
- 112
- 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
- 109
- 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
- 131
- 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
- 100
- April 8, 2025
【EXPERT Q&A】What qualifications are required for the export of cosmetic raw materials?

Drugdu.com expert’s response: Depending on the target market, exporting cosmetic ingredients requires compliance with China’s export qualifications, import regulations of the target country, and international certification standards. Below are the specific requirements: I. China’s Export Qualification Requirements 1. Enterprise Qualification Registration Customs Registration: Complete the Registration for Foreign Trade Operators and obtain the registration certificate. Business License: The scope of business must include “import/export of goods” or “import/export of technology,” and a copy of the license must be provided. Tax Compliance: Submit the tax registration certificate (if the three certificates have been integrated, it is included in the business license). Foreign Exchange and Tax Rebates: Complete the procedures for opening a foreign exchange account and registering for export tax rebates (if applicable). 2. Product Compliance Documents Material Safety Data Sheet (MSDS): Outline the physical and chemical properties, toxicity, first aid measures, etc., of the ingredients. Component Analysis Report: Issued by a qualified ...
- Source: drugdu
- 88
- April 7, 2025
【EXPERT Q&A】What are the advantages and disadvantages of the implementation of drug test data protection management measures?

Drugdu.com expert’s response: The implementation of the Measures for the Protection and Management of Drug Trial Data has significant dual advantages and disadvantages, requiring comprehensive assessment from multiple dimensions including institutional innovation, market competition, and patient needs. The following analysis is based on specific cases and policy logic: I. Core Benefits: Driving Innovation and Regulating the Market Innovation Incentives and Long-term Investment Guarantee Market Exclusivity Period Forms a Return Loop: Innovative drug companies need to invest decades of time and hundreds of millions of dollars in clinical trials. Data protection ensures they can recover costs and obtain reasonable profits through a market exclusivity period of 6-12 years (e.g., Keppra was approved for marketing in over 90 countries through protection), enabling continuous investment in the next generation of drug development. First Generic Drug Incentives Fill Gaps: Providing a 3-year data protection period for the first generic drug (e.g., the first generic ...
- Source: drugdu
- 116
- April 4, 2025
【EXPERT Q&A】What is the difference between siRNA and shRNA in RNA interference technology?

Drugdu.com expert’s response: I. Molecular Structure and Synthesis siRNA: A chemically synthesized or in vitrotranscribed double-stranded RNA molecule, comprising 21–23 base pairs with 2–3 nucleotide overhangs at both ends. Directly delivered to the cytoplasm, where it binds to the RNA-induced silencing complex (RISC) to guide targeted mRNA cleavage. Rapid onset of action (within hours) but has a shorter half-life (typically hours to two days), requiring repeated dosing. Recent advancements in chemical modifications (e.g., 2′-O-methylation, phosphorothioate bonds) have extended stability to ~1 week. Systemic delivery still relies on lipid nanoparticles or GalNAc conjugation for tissue targeting. shRNA: A single-stranded RNA delivered via plasmid or viral vectors. Its hairpin structure is transcribed by RNA polymerase III (Pol III) in the nucleus and processed by Dicer enzyme into functional siRNA. Delayed onset (24–72 hours) but offers sustained gene silencing for weeks to months. Ideal for stable gene knockdown models (e.g., neurodegenerative disease studies using ...
- Source: drugdu
- 122
- April 2, 2025
【EXPERT Q&A】What is Antibody-polypeptide Conjugate (APC)?

Drugdu.com expert’s response: Antibody-Peptide Conjugate (APC) is a specialized biopharmaceutical that links an antibody with a peptide through specific chemical bonds. This conjugate combines the targeting properties of the antibody with the biological activity of the peptide, enabling precise treatment of specific cells or tissues. Below is a detailed explanation of Antibody-Peptide Conjugate (APC): I. Definition and Structure Antibody-Peptide Conjugate (APC) is a complex formed by chemically linking an antibody and a peptide. The antibody is responsible for recognizing and binding to specific antigens on target cells or tissues, while the peptide carries therapeutically active molecules or groups. This structure allows APC to precisely target diseased sites while releasing therapeutic peptides, achieving localized high-concentration drug treatment. II. Preparation and Application Preparation Method: Antibody Reduction: Firstly, the interchain disulfide bonds of the antibody are reduced to produce thiol groups, providing active sites for subsequent conjugation reactions. Peptide Conjugation: Then, the chemically modified ...
- Source: drugdu
- 94
- March 31, 2025
【EXPERT Q&A】What is the difference between fsma certification and brc certification?

Drugdu.com expert’s response: FSMA certification and BRC certification both occupy an important position in the food industry, but they differ significantly in multiple aspects. Here are the main differences between the two: I. Establishing Institution and Background FSMA certification: Implemented by the U.S. Food and Drug Administration (FDA), it stands for Food Safety Modernization Act certification. This certification was developed in response to the rapid changes in the global food system and the challenge of foodborne illnesses, aiming to ensure the safety of the food supply chain through preventive measures. BRC certification: Established by the British Retail Consortium (BRC), it was initially formulated for food producers supplying food to the UK. Subsequently, it has evolved into a global food safety standard widely used in food production and supply chain management worldwide. II. Scope of Application and Focus FSMA certification: Primarily targets food produced in the United States and imported into ...
- Source: drugdu
- 90
- March 28, 2025
【EXPERT Q&A】What are the implementation standards for DCS systems of pharmaceutical companies?

Drugdu.com expert’s response: DCS (Distributed Control System) is the core automation system in pharmaceutical manufacturing, requiring adherence to three critical objectives: compliance, data integrity, and system reliability. Below is a detailed breakdown based on international regulations, industry practices, and technical requirements: I. International Regulations & Industry Standards GMP Compliance FDA 21 CFR Part 11: Mandates electronic records and signatures, ensuring DCS data storage, modification, and audit trails meet regulatory standards. EU GMP Annex 11: Focuses on computerized system validation, including access control, data backup, and cybersecurity. ICH Q9/Q10: Risk-based quality systems requiring DCS to identify Critical Process Parameters (CPPs) and mitigate quality risks. GAMP 5 Guidelines: Classifies DCS as Category 4 (Configurable Software), requiring full lifecycle validation (URS, FAT, SAT, IQ/OQ/PQ). ISO Standards ISO 9001: Ensures quality management for DCS suppliers. ISO 27001: Protects DCS from cyber threats via information security protocols. II. Technical & Functional Requirements Data Integrity (ALCOA+ Principles) Traceability: Full operational ...
- Source: drugdu
- 101
- March 26, 2025

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