Expert Q&A – Page 4 – media

【EXPERT Q&A】Which countries’ certificates can be converted after CB certification?

Drugdu.com expert’s response: After obtaining CB certification, manufacturers can convert it into certification for multiple countries. The CB Scheme is based on International Electrotechnical Commission (IEC) standards, through which manufacturers can use a CB Test Certificate issued by a National Certification Body (NCB) to obtain national certifications from other member countries of the CB Scheme. Here are some of the national certifications that can be converted from CB certification: Ⅰ. Countries Where CB Certification Can Be Converted Europe: Germany (VDE, GS, etc.) / France / United Kingdom / Netherlands / Spain / Italy / Austria / Sweden / Switzerland, etc. Americas: United States (UL, ETL, etc.) / Canada (CSA, ULC, etc.) / Mexico / Brazil. Asia-Pacific: Australia (RCM, SAA, etc.) / New Zealand / Japan / South Korea (KC Mark) / Singapore / India / Thailand. Other Regions: South Africa / Turkey / Russia / Ukraine / Argentina / Brazil (Note: Listed twice as Brazil is mentioned in both Americas and Other ...
- Source: drugdu
- 71
- September 11, 2024
【EXPERT Q&A】Why domestic medical device bidding needs CE certification?

Drugdu.com expert’s response: The reasons for requiring CE certification in domestic medical device tenders can be elaborated from multiple perspectives: Ⅰ. International Recognition and Market Access of CE Certification International Recognition: CE certification is a prerequisite for market access in Europe. Medical devices with CE certification must comply with European standards such as EN60601 and EN45545. This signifies that CE certification not only enjoys a high level of recognition in the European market but is also globally recognized as an important indicator of product quality and safety. Market Access: For medical device manufacturers aiming to enter the European market, CE certification is indispensable. Without the CE mark, it is illegal to sell or distribute medical devices within the European Economic Area. Therefore, requiring CE certification for domestic medical devices in tenders helps enhance their competitiveness in international markets. Ⅱ. Enhancing Product Quality and Safety Quality Improvement: To obtain CE certification, ...
- Source: drugdu
- 61
- September 9, 2024
【EXPERT Q&A】What are the six bases for the classification of import and export commodities?

Drugdu.com expert’s response: The six major bases for the classification of import and export commodities mainly include the following aspects: Ⅰ. The Harmonized System Convention on Commodity Nomenclature and Coding (HS Convention) Commodity Classification System: The classification of import and export commodities is first and foremost conducted under the commodity classification system of the Harmonized System Convention (abbreviated as HS Convention). This is an internationally recognized standard for commodity classification, used for coding and categorizing commodities in global trade. Ⅱ. Customs Tariff of the People’s Republic of China: The Customs Tariff serves as the fundamental document for China’s customs authorities to classify and levy taxes on import and export commodities. It provides detailed listings of tariff numbers and rates for various commodities, serving as a crucial basis for determining the coding and tariff rates of import and export commodities. Ⅲ. Explanatory Notes to the Customs Tariff of the People’s Republic ...
- Source: drugdu
- 76
- September 6, 2024
【EXPERT Q&A】Where to check pharmacovigilance data?

Drugdu.com expert’s response: Regarding the inquiry of pharmacovigilance data, you can access the following specific agencies: Ⅰ. National Medical Products Administration (NMPA) and Its Subsidiaries NMPA Official Website: Each year, the NMPA releases the “Annual Report on National Adverse Drug Reaction Monitoring,” which informs the public of the annual status of adverse drug reaction monitoring in China. These reports and related pharmacovigilance information can be found on the NMPA’s official website (nmpa.gov.cn). National Center for Adverse Drug Reaction Monitoring (NCADR): The NCADR regularly compiles and publishes domestic pharmacovigilance information, as well as international pharmacovigilance alerts. This information can also be accessed on the NMPA’s official website or the NCADR’s official website (cdr-adr.org.cn). Ⅱ. Local Governments and Agencies Some local governments or drug regulatory agencies may have established their own pharmacovigilance databases or information platforms. For instance, Shandong Province has the “Medication ‘Alert’ Platform,” which utilizes information technology to provide channels ...
- Source: drugdu
- 81
- September 5, 2024
【EXPERT Q&A】What are the advantages and disadvantages of antibody drugs versus RNA drugs?

Drugdu.com expert’s response: Antibody drugs and RNA drugs are two distinct categories of biotechnology medications, each possessing unique strengths and weaknesses. Below is a detailed analysis of their respective advantages and disadvantages: Ⅰ. Advantages of Antibody Drugs High Specificity: Antibody drugs can specifically recognize and bind to target antigens, typically proteins on cell surfaces, providing a high degree of selectivity that minimizes damage to normal cells. Long-lasting Effect: Antibody drugs typically have longer half-lives, enabling extended duration of action within the body, reducing the frequency of dosing and enhancing patient convenience. Low Immunogenicity: Fully humanized antibody drugs exhibit lower immunogenicity, mitigating the risk of immune reactions and improving drug tolerability and safety. High Success Rate: In clinical studies, antibody drugs demonstrate significantly higher success rates compared to traditional small-molecule chemical drugs. In the US, approximately 25%-30% of large-molecule drugs (including antibody drugs) entering clinical trials are ultimately approved for market, ...
- Source: drugdu
- 75
- September 2, 2024
【EXPERT Q&A】What are Radioactive Drug Conjugates (RDCs)?

Drugdu.com expert’s response: Radioactive Drug Conjugates (RDCs) represent a novel class of therapeutic agents that combine the strengths of precise targeting and potent killing capabilities. By linking radioactive nuclides to ligands (such as antibodies, peptides, small molecules, etc.) through linkers and chelators, RDCs achieve precise localization and effective eradication of target cells. Below, I will elaborate on RDCs from four aspects: definition and structure, advantages and applications, classification, as well as challenges and prospects. I. Definition and Structure Definition: RDCs are drug formulations that integrate radioactive nuclides with targeting molecules (ligands) through linker arms (connectors), aimed at delivering precise strikes against tumor or other disease targets. Structure: RDC drugs consist primarily of targeting ligands, linker arms, chelators, and nuclide conjugates. The targeting ligands recognize and bind to specific target cells or tissues; linker arms connect the targeting ligands to the radioactive nuclides; chelators stabilize the radioactive nuclides, preventing their premature ...
- Source: drugdu
- 67
- August 30, 2024
【EXPERT Q&A】What are the advantages of MDSAP medical device system certificate?

Drugdu.com expert’s response: The MDSAP (Medical Device Single Audit Program), also known as the “Medical Device Single Audit Program,” is an audit process recognized and joined by five medical device regulatory agencies from the United States FDA, Australia TGA, Brazil ANVISA, Canada HC, and Japan MHLW. This system certification brings numerous benefits and advantages to medical device manufacturers, primarily in the following aspects: I. Streamlining the Audit Process Reducing Redundant Audits: MDSAP employs a one-time audit process that encompasses the regulatory requirements of multiple countries. Manufacturers need to undergo a single audit to meet market access requirements across participating nations, eliminating the duplication of effort and time waste associated with multiple audits. Unifying Audit Standards: MDSAP certification ensures that a manufacturer’s quality management system and products align with the audit standards and requirements of the five participating countries and regions, facilitating consistency in quality and compliance and simplifying audit procedures ...
- Source: drugdu
- 68
- August 28, 2024
【EXPERT Q&A】Do I need to apply for Import License in Germany when exporting insulin apis to Germany?

Drugdu.com expert’s response: Regarding the question of whether an Import License is required for exporting insulin Active Pharmaceutical Ingredients (APIs) to Germany, I will address this from both international trade and pharmaceutical regulatory perspectives. Hopefully, this will provide you with valuable insights. Firstly, it is crucial to note that Germany, as a member of the European Union (EU), subjects the import and sale of pharmaceutical products, including APIs, to stringent regulatory frameworks. Typically, the import of pharmaceuticals (APIs included) must comply with the relevant EU and German laws and regulations. Whether an Import License is necessary for insulin APIs exported to Germany depends on several factors: I. EU and German Pharmaceutical Regulatory Policies: The EU’s pharmaceutical regulatory system may require prior import authorization or certification for certain pharmaceuticals or APIs. Therefore, it is essential to consult the latest EU and German pharmaceutical regulations to determine if insulin APIs are subject ...
- Source: drugdu
- 86
- August 26, 2024
【EXPERT Q&A】What is a passive medical device?

Drugdu.com expert’s response: Passive medical devices refer to those that do not rely on external energy sources (such as electricity or batteries) to perform their intended functions. These devices typically utilize physical principles like mechanics, optics, acoustics, and thermodynamics to achieve their functions, with their energy primarily derived from the human body itself or gravitational forces. I. Characteristics of Passive Medical Devices Energy Source: Passive medical devices do not depend on external power sources or other forms of energy. Instead, they operate directly using natural forces such as the human body or gravity. Function Realization: They achieve their intended medical functions through physical principles like mechanical force, pressure, optical properties, etc. Safety: Since they do not rely on external power, these devices generally do not generate electromagnetic interference or radiation during use, making them safer for the human body. II. Classification of Passive Medical Devices Passive medical devices can be ...
- Source: drugdu
- 69
- August 26, 2024
【EXPERT Q&A】Can veterinary drug API companies succeed in CDMO transformation?

Drugdu.com expert’s response: I agree that the success of a veterinary API (Active Pharmaceutical Ingredient) company’s transition to CDMO (Contract Development and Manufacturing Organization) hinges on both the potential for success and the crucial factors that contribute to it. Here’s a translation of your points into English: I. Potential for Successful Transition Market Demand: With the rapid development of the global pharmaceutical industry, the veterinary drug market has also shown a steady growth trend. The transition of veterinary API companies to CDMO can cater to the outsourcing needs in veterinary drug R&D and production, particularly for those lacking in-house R&D and manufacturing capabilities, making CDMO services all the more crucial. Technical Accumulation: Veterinary API companies have accumulated substantial technical experience and production capabilities through their manufacturing processes, which can be effectively leveraged during the transition to CDMO. By enhancing their R&D capabilities and service standards, these companies can offer higher-quality, ...
- Source: drugdu
- 99
- August 23, 2024

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