Expert Q&A – Page 5 – media

【EXPERT Q&A】Do Mexican apis need to be registered separately or in conjunction with preparations?

Drugdu.com expert’s response: The registration requirements for Active Pharmaceutical Ingredients (APIs) in Mexico typically involve a separate registration process, rather than simply being associated with the registration of the final dosage form. This is because APIs, as the essential components of dosage forms, have a direct impact on the quality, safety, and efficacy of the final product. Registration Requirements for APIs in Mexico Approval from the Mexican Ministry of Health: The export of APIs to Mexico requires approval from the Mexican Ministry of Health. This signifies that APIs must comply with Mexico’s local pharmaceutical regulations and standards. COFEPRIS Registration: Manufacturers of APIs need to register with the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), which is the primary agency under the Mexican Ministry of Health responsible for regulating drugs, medical devices, cosmetics, and hygiene products. During the registration process, companies must submit a range of documents, including but not limited ...
- Source: drugdu
- 74
- September 18, 2024
【EXPERT Q&A】How to prepare for AEO certification?

Drugdu.com expert’s response: AEO certification (Authorized Economic Operator) is a system implemented by customs authorities to certify enterprises with good credit standing, compliance, and security management, granting them customs clearance facilitation. Before embarking on the AEO certification process, enterprises need to prepare thoroughly as follows: Ⅰ. Understanding AEO Certification Standards and Requirements Familiarize with Certification Standards: Enterprises should thoroughly read and comprehend the “Customs High-Level Certified Enterprise Standards,” which encompass general standards and specific standards tailored to different types of enterprises, such as importers/exporters of goods and customs brokers. Clarify Application Conditions: Ensure that the enterprise meets the basic conditions for AEO certification, including registration and filing, sound financial status, and lawful operations. Ⅱ. Internal Preparation Comprehensive Review and Self-Assessment: Conduct a comprehensive review of the enterprise’s production and operation, import and export activities, financial data, etc., ensuring their authenticity, accuracy, and completeness. Examine whether the enterprise’s internal control system, ...
- Source: drugdu
- 75
- September 16, 2024
【EXPERT Q&A】What certification is required for medical device export clearance to the United States?

Drugdu.com expert’s response: Exporting medical devices to the United States for customs clearance involves fulfilling a series of certifications and requirements, primarily encompassing the following aspects: Ⅰ. FDA Registration and Certification FDA Registration: Manufacturers or exporters need to register with the Food and Drug Administration (FDA) in the United States to legally sell medical devices in the American market. This process is typically completed through FDA’s Electronic Registration System (FURLS). 510(k) Premarket Notification: For medical devices classified as “Class II” (Premarket Notification), a 510(k) submission is generally required. This application demonstrates that the device is technologically similar to a legally marketed device and meets FDA requirements. The review period typically takes 90 days. PMA Application: For high-risk medical devices classified as “Class III” (Premarket Approval), a PMA (Premarket Approval Application) may be necessary. This is a more rigorous application requiring substantial clinical data and evidence to prove the safety and ...
- Source: drugdu
- 75
- September 13, 2024
【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
- 77
- 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
- 67
- 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
- 82
- 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
- 87
- 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
- 85
- 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
- 76
- 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
- 74
- August 28, 2024

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