Expert Q&A – Page 5 – media

【EXPERT Q&A】What are the certification requirements for WC?

Drugdu.com expert’s response: WC, fully known as Written Confirmation, is a requirement for non-EU countries exporting Active Pharmaceutical Ingredients (APIs) to the EU market. The certification requirements for WC can be elaborated from the following aspects: I. Certification Authority and Document Issuance The WC certification document is an official document issued by the pharmaceutical regulatory authority of the API-producing country. This document certifies that the exported APIs comply with the Good Manufacturing Practice (GMP) standards of the EU. II. Application Conditions and Prerequisites Prerequisites: Pharmaceutical GMP certification involves rigorous audits of a manufacturer’s quality management system, production processes, equipment, and personnel to ensure that the drugs produced meet the relevant quality and safety requirements of the EU. Only enterprises that have passed GMP certification can obtain WC documents to export APIs to the EU market. Application Conditions: These typically include production licenses, descriptions of the quality management system, product details, ...
- Source: drugdu
- 105
- October 18, 2024
【EXPERT Q&A】What certification is required for drug export to Vietnam?

Drugdu.com expert’s response: Exporting pharmaceutical products to Vietnam requires a series of certifications to ensure compliance with Vietnamese regulations and legal sale in the Vietnamese market. Here are the primary certification requirements: Ⅰ. Free Sales Certificate (FSC) from the Drug Regulatory Authority and Vietnam Embassy Authentication Free Sales Certificate (FSC) from the Drug Regulatory Authority: Definition: The Free Sales Certificate, also known as the Export Sales Certificate, is an official document issued by the drug regulatory authority, certifying that a particular pharmaceutical product or medical device meets relevant national standards and directives, allowing its free sale within the country and export to other countries. Role: In international trade, the FSC is a crucial document for enhancing a product’s international competitiveness, particularly when exporting to overseas markets like Vietnam, where it validates the legality and quality of the pharmaceutical products. Vietnam Embassy Authentication: Definition: Vietnam Embassy Authentication is an official certification ...
- Source: drugdu
- 87
- October 16, 2024
【EXPERT Q&A】What are the precautions for import and export goods entering and leaving the customs?

Drugdu.com expert’s response: When importing and exporting goods through customs, various aspects need to be taken into consideration to ensure smooth customs clearance and compliance with relevant regulations. Here are some key considerations: Ⅰ. Documentation Preparation Complete and Accurate Documentation: Import-export enterprises must prepare complete documents, including bills of lading, invoices, packing lists, contracts, import-export licenses (if required), certificates of origin, inspection and quarantine certificates, etc. These documents must be accurate and in line with customs requirements. Compliant Declaration: Ensure that the declared information for goods is accurate, including commodity names, quantities, values, origins, etc. The declared value should match the actual value to avoid issues arising from over- or under-declaration. Ⅱ. Commodity Classification and Taxation Accurate Classification: Accurate classification of goods is crucial, as it directly determines the Harmonized System (HS) code, which further influences tariff rates and regulatory conditions. Misclassification can lead to unnecessary troubles and losses. Tax ...
- Source: drugdu
- 95
- October 14, 2024
【EXPERT Q&A】Can metformin fight aging?

Drugdu.com expert’s response: Metformin, a widely used antidiabetic drug, has shown potential in recent research on anti-aging. Specifically, its anti-aging effects are manifested in the following aspects: Ⅰ. Scientific Research Achievements Research by the Chinese Academy of Sciences Team: After an extensive 8-year study, the team led by Liu Guanghui from the Institute of Zoology, Chinese Academy of Sciences, discovered that metformin can reset the intrinsic program of cellular aging, significantly delaying aging in primates. This achievement was published in the journal “Cell”, providing new insights into the biological mechanisms of aging and potential strategies for future interventions in human aging. Experimental Evidence: The research team conducted a 40-month follow-up study on middle-aged and elderly male crab-eating macaques. The results showed that individuals who took metformin long-term exhibited significant delays in aging, including reduced brain cortex atrophy, improved cognitive function, delayed periodontal bone degeneration, and protection of multiple tissues and ...
- Source: drugdu
- 84
- October 11, 2024
【EXPERT Q&A】What is the South African drug export registration process?

Drugdu.com expert’s response: The process of exporting and registering pharmaceutical products in South Africa is a relatively complex and meticulous endeavor, involving multiple stages and documentation requirements. Here is an overview of the process: Ⅰ. Preliminary Preparation Product Classification: Firstly, it is crucial to determine the classification of the pharmaceutical product in South Africa, as different classifications may entail different registration requirements and procedures. Preparation of Technical Documentation: This typically includes detailed information about the product, such as its composition, indications, dosage form, quality standards, as well as technical specifications, design descriptions, and performance test results that demonstrate the product’s safety, efficacy, and performance. Collection of Clinical Data: Depending on the requirements, relevant clinical data must be provided to support the product’s clinical performance and effectiveness. This may encompass clinical trial results, case studies, literature reviews, etc. Corporate Qualification: Ensure that the exporting company has a legal registration status in ...
- Source: drugdu
- 113
- October 9, 2024
【EXPERT Q&A】How to obtain the 510K number for medical device export to the United States?

Drugdu.com expert’s response: Exporting medical devices to the United States and obtaining a 510K number involves adhering to the regulations and procedures set forth by the U.S. Food and Drug Administration (FDA). Ⅰ. Understanding the Basics of 510K 510(k) is a premarket notification program established by the FDA, named after Section 510(k) of Chapter 21 of the Federal Food, Drug, and Cosmetic Act. This program requires manufacturers to submit a “510(k) Premarket Notification” to the FDA before introducing a new medical device or making significant modifications to an existing one and reintroducing it to the market. The purpose of this submission is to demonstrate that the newly developed medical device is substantially equivalent in safety and effectiveness to a similar device that has already been approved by the FDA. Ⅱ. Determining Product Classification First, it is essential to determine the classification of the medical device. The FDA categorizes medical devices ...
- Source: drugdu
- 104
- October 7, 2024
【EXPERT Q&A】What documents are needed for drug import declaration? Why?

Drugdu.com expert’s response: The requirements for documents in drug import customs clearance are complex and comprehensive, aiming to ensure the quality, safety, and legality of imported drugs in compliance with China’s drug administration regulations. Ⅰ. Key Documents Import Drug Registration Certificate (or Pharmaceutical Product Registration Certificate) Reason: Verifies that the drug has been registered in China and approved by relevant national departments, allowing for legal sale and use domestically. Drug Business License or Drug Production License and Enterprise Legal Person Business License Reason: Demonstrates that the enterprise importing drugs possesses the legal qualifications for drug operation or production, as well as the legitimacy and scope of business. Certificate of Origin Reason: Proves the origin of the imported drugs, serving as an important basis for customs import administration and tariff collection. Purchase Contract Reason: Verifies the authenticity and legality of the transaction for imported drugs, including information on buyer and seller, transaction quantity, price, etc. Packing List, ...
- Source: drugdu
- 97
- October 4, 2024
【EXPERT Q&A】What is the role, definition, and inquiry of the FDA Consensus Standard for medical devices?

Drugdu.com expert’s response: FDA medical device consensus standards play a pivotal role in the medical device industry. Ⅰ. The Role of FDA Medical Device Consensus Standards Ensuring Safety and Effectiveness: These standards assist manufacturers in ensuring that their medical devices meet safety and effectiveness requirements during design, manufacturing, and usage, thereby safeguarding the health of patients and users. Streamlining Regulatory Processes: Manufacturers can leverage these consensus standards to fulfill FDA regulatory requirements, reducing the need for redundant testing and evaluations, which accelerates pre-market approval timelines. Enhancing Transparency: Consensus standards provide clear benchmarks for medical device performance and safety, contributing to increased industry transparency and fostering fair competition. Facilitating International Harmonization: Many FDA-recognized medical device consensus standards are international, simplifying international trade and market access, thereby promoting coordinated development of the global medical device market. Ⅱ. Definition of FDA Medical Device Consensus Standards FDA medical device consensus standards refer to a ...
- Source: drugdu
- 92
- October 2, 2024
【EXPERT Q&A】What is the latest development of FIC drugs?

Drugdu.com expert’s response: FIC (First-in-class) drugs, as their name implies, are the first medications of their kind with entirely novel and unique mechanisms of action, pioneering the treatment of specific diseases. Their latest advancements can be outlined from several perspectives: Ⅰ. Overview of FIC Drugs Globally and in China Global Scope: According to publicly available information, the FDA approved a total of 55 new drugs in 2023, among which 20 were FIC drugs, accounting for 36% of the total. This underscores the pivotal role of FIC drugs in the global drug discovery and development landscape. Chinese Scope: Chinese enterprises are increasingly focusing on innovative drugs. In 2023, 30 of the newly approved drugs in China were developed domestically, constituting 37% of the overall approvals. Furthermore, Chinese scholars’ publications in authoritative journals indicate a significant increase in the total number of innovative products in China’s pipeline, with FIC products growing from ...
- Source: drugdu
- 127
- September 30, 2024
【EXPERT Q&A】What is the difference between medical devices and non-medical devices?

Drugdu.com expert’s response: The differences between medical devices and non-medical devices are primarily manifested in the following six aspects: Ⅰ. Definition and Purpose Medical Devices: Refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related articles, including the necessary computer software, that are directly or indirectly used on the human body. Their efficacy is primarily obtained through physical means rather than through pharmacology, immunology, or metabolism, or if these means are involved, they only play an auxiliary role. The primary purposes include diagnosis, prevention, monitoring, treatment, or alleviation of diseases, as well as diagnosis, monitoring, treatment, alleviation, or functional compensation of injuries. Non-Medical Devices: Generally refer to products that are not directly used on the human body or, even if in contact with the human body, do not have a medical purpose. They may be daily necessities, industrial products, consumer goods, such as ...
- Source: drugdu
- 110
- September 27, 2024

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