Expert Q&A – Page 7 – media

【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
- 92
- 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
- 81
- 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
- 79
- 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
- 122
- 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
- 92
- 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
- 144
- August 23, 2024
【EXPERT Q&A】What is the export procedure of proprietary Chinese medicine?

Drugdu.com expert’s response: To successfully export proprietary Chinese medicines, the following processes are required: I. Preliminary Preparations Understanding Target Market Regulations: Prior to exporting traditional Chinese medicines (TCMs), enterprises must conduct thorough research on the relevant regulations of the target market, including import registration requirements, quality standards, and certification systems. This information is crucial for ensuring the smooth entry of TCMs into the target market. Product Preparation: a. Ensure that the exported TCMs comply with relevant quality standards and possess valid drug production licenses and drug registration certificates issued by the national drug regulatory authority. b. Prepare product specifications, labels, packaging, etc., ensuring they comply with the regulatory requirements of the target market. Finding Partners: Identify suitable partners, such as importers, agents, or distributors. Selecting the right partners can help enterprises better understand the target market and reduce export risks. II. Preparation of Application Materials Basic Information of Medicines: Detailed information on the TCMs ...
- Source: drugdu
- 102
- August 20, 2024
【EXPERT Q&A】Why do import and export enterprises have to do AEO certification?

Drugdu.com expert’s response: The necessity for import-export enterprises to undergo AEO (Authorized Economic Operator) certification primarily stems from the following aspects: I. Enhancing International Competitiveness 1.High International Recognition: AEO certification, a globally recognized standard formulated by the World Customs Organization (WCO), carries international mutual recognition. Enterprises with AEO certification are regarded as secure and reliable trading partners in international trade, thereby enhancing their international credibility and reputation. 2.Priority Customs Clearance: AEO-certified enterprises enjoy preferential treatment such as priority processing and reduced inspections, including diminished time and procedures for customs inspections, border controls, and logistics security. This expedites cargo clearance, shortens the dwell time at customs, and improves both export and import efficiency. II. Reducing Costs and Improving Efficiency 1.Lower Inspection and Audit Frequencies: AEO-certified enterprises benefit from reduced inspection rates and audit frequencies during import-export activities, minimizing unnecessary inconveniences and additional expenses. This helps to lower international trade costs, encompassing ...
- Source: drugdu
- 118
- August 19, 2024
【EXPERT Q&A】Do foreign trade without import and export rights are there other ways to export?

Drugdu.com expert’s response: When foreign trade enterprises do not possess import and export rights, there are indeed alternative methods to achieve exports. These methods primarily encompass: I. Export Under Billing This refers to units without import and export rights using the name of another import and export company for export purposes. The specific operational process is as follows: 1.Purchase of Export Documents: Acquire a set of export customs declaration documents, which will be used for customs clearance procedures. 2.Submission of Customs Declaration Materials: Submit the purchased customs declaration materials to a customs broker or freight forwarder for customs clearance. Once the goods are successfully declared and released, the process of export under billing is completed. 3.Handling of Customs Clearance Documents: The information used for customs declaration may differ from the header company for customs clearance documents provided to the recipient at the destination port, but documents must be consistent, meaning ...
- Source: drugdu
- 113
- August 16, 2024
【EXPERT Q&A】How to apply for the management record of Class II medical devices?

Drugdu.com expert’s response: The application process for the Class II medical device operation registration mainly involves the following steps: Ⅰ. Prepare Registration Materials 1.Enterprise Qualification Documents: Copy of the enterprise’s business license, certifying its legal business qualifications. 2.Organization code certificate (if applicable), verifying the enterprise’s organization code. 3.dentity cards, educational background, or professional title certificates of the enterprise’s legal representative or person in charge, and quality managers, to verify the identity and qualifications of relevant personnel. 4.Quality Management Personnel and Professional Technical Personnel Information: Work resumes of quality management personnel. 5.A list of professional technical personnel, along with their identity cards, educational certificates, and professional title certificates, to demonstrate the enterprise’s quality management capabilities and professional technical proficiency. 6.Business Premises and Warehouse Information: Geographical location maps and floor plans of the enterprise’s business premises and warehouse addresses, as well as commercial property ownership certificates, red lease contracts, or site usage certificates, to prove ...
- Source: drugdu
- 123
- August 14, 2024

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