Expert Q&A – Page 2 – media

【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
- 90
- 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
- 66
- 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
- 107
- 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
- 97
- 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
- 98
- 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
- 112
- 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
- 88
- 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
- 85
- 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
- 100
- 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
- 108
- April 2, 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.