Expert Q&A – media

【EXPERT Q&A】What are the principle of action and advantages of peptide-conjugated radionuclide drugs (PRC)?

Drugdu.com expert’s response: Peptide-radionuclide conjugates, in common contexts, are often categorized under PRRT (Peptide Receptor Radionuclide Therapy) or radiopharmaceutical conjugates. Its core concept can be summed up in one sentence: the peptide is responsible for “targeting the site”, while the radionuclide takes charge of “killing tumor cells”. This type of drug usually consists of several parts: a peptide that can recognize tumor-associated receptors, a linker/chelation structure, and a radionuclide for diagnosis or therapy. The peptide segment binds to specific receptors highly expressed on the surface of tumor cells, such as the somatostatin receptors commonly seen in neuroendocrine tumors. After binding, the receptor-peptide complex can be internalized by the cell, and the radionuclide subsequently releases radiation near or inside the tumor cell, causing DNA damage to inhibit or kill the tumor cell. PRRT precisely uses radiolabeled peptides to selectively target tumor cells that express the corresponding receptors, delivering therapeutic radiation to ...
- Source: drugdu
- 46
- October 2, 2026
【EXPERT Q&A】The buyer has started to ask about the annual purchase volume and long-term pricing. At which stage has this inquiry progressed?

Drugdu.com expert’s response: In pharmaceutical foreign trade inquiries, many communications start off very lightly. Buyers first ask if the product is available, then review the COA, specifications, and price, and sometimes request samples. At this stage, suppliers are mostly confirming product compatibility, while buyers are still screening options. However, when the conversation progresses to the point where buyers start asking about annual purchase volumes, long-term pricing, and stable supply capabilities, the situation changes. For example, if a buyer begins to inquire about how much goods they will need in a year, whether quarterly deliveries are possible, and if prices can be recalculated for long-term cooperation, such questions usually indicate that they are no longer just considering “whether they can make a single purchase” — they are assessing whether the supplier can be included in their long-term cooperation network. Of course, this does not mean an order will be placed immediately. ...
- Source: drugdu
- 81
- September 30, 2026
【EXPERT Q&A】The buyer said that the sample test has passed. How can the project be pushed to a trial order next?

Drugdu.com expert’s response: In pharmaceutical foreign trade, after sending out samples, the sentence that every salesperson most looks forward to seeing is probably: “Sample passed our test.” However, upon receiving this message, some sales representatives do not know how to follow up properly. They simply reply: “Great, looking forward to your order.” And then start waiting. Several days pass with no order from the client; a week later, they send another message: “Any update?” The client replies: “We are still discussing internally.” Gradually, the entire project grinds to a halt. A sample passing the test is certainly good news, but there is usually a noticeable gap between “qualified sample” and “formal procurement”. At this stage, what suppliers need to confirm is no longer whether the product is usable, but how the client plans to make the purchase. Confirm the purchase quantity and timeline right after sample approval The sample phase is meant to ...
- Source: drugdu
- 61
- September 28, 2026
【EXPERT Q&A】When a buyer makes an inquiry and only leaves the product name and country, which questions should be asked in the first round?

Drugdu.com expert’s response: In pharmaceutical foreign trade, it is very common to receive extremely short inquiries. For example: “Need Vitamin D3, Pakistan.” or “Looking for disposable syringe, UAE.” Sometimes buyers only leave the product name, country and email address, with no other information provided. There are no specifications, no quantity, no intended use, and no explanation of whether they are importers, distributors or end purchasers. Such inquiries cannot be directly judged as invalid. Some buyers are just testing whether the supplier will respond, some are sourcing goods for their end clients, and some have not sorted out their complete requirements yet. The focus of your first reply is not to quote immediately, nor to send all product catalogs and certificates at once. Instead, you should first ask for several most critical pieces of information. Confirm the specific specification or model first The product name alone provided by the buyer is ...
- Source: drugdu
- 83
- September 25, 2026
【EXPERT Q&A】How to apply for a medical device registration certificate?

Drugdu.com expert’s response: For medical device registration certificate application, the first step is not to immediately prepare a large stack of materials, but to determine which risk class the product belongs to. In China, medical devices are categorized into Class I, Class II and Class III based on their risk levels. Class I devices are subject to record-filing management, while Class II and Class III devices are subject to registration management. The “medical device registration certificate application” that enterprises usually refer to mainly targets Class II and Class III products. For domestic Class III devices, as well as imported Class II and Class III devices, the National Medical Products Administration (NMPA) is responsible for the review, evaluation and approval. Domestic Class II devices are generally registered under the charge of provincial drug regulatory authorities. After clarifying the product classification, you need to confirm the registration applicant and the production relationship. ...
- Source: drugdu
- 94
- September 23, 2026
【EXPERT Q&A】If the buyer requests COA, GMP and DMF at one time, do all the documents need to be sent?

Drugdu.com expert’s response: When exporting APIs, excipients, and peptide APIs, suppliers often receive inquiries like this. After asking about the product and price, the buyer quickly adds: “Please send COA, GMP and DMF.” Some suppliers may think the buyer is professional and immediately send all the documents they have. Others may be more cautious, worry about sensitive information, and simply reply: “Available.” Neither approach is ideal. When a buyer asks for COA, GMP and DMF at once, it may mean that this is not just a casual price inquiry. The buyer may already be checking whether the product can move forward to purchasing, registration, or supplier qualification. But what documents to send, and how much to share, still depends on the project stage. First, understand why the buyer needs these documents Even when buyers ask for the same documents — COA, GMP and DMF — their purpose may be different. Some buyers ...
- Source: drugdu
- 115
- September 21, 2026
【EXPERT Q&A】A Buyer Asked for Free Samples in the First Inquiry. Should You Send Them Right Away?

Drugdu.com expert’s response: If you’re working in the pharmaceutical or medical device export business, you’ve probably seen inquiries like this: Before discussing pricing or technical details, the buyer simply asks: “Can you provide free samples?” Some suppliers see this as a positive signal. They assume the buyer is ready to evaluate the product and hope that sending samples quickly will increase the chance of winning the order. Others become cautious immediately, worrying that the buyer is only looking for free samples with no real purchasing intention. In reality, both conclusions may be premature. A sample request shows that the buyer is interested enough to evaluate the product, but it doesn’t tell you why they need the sample, what they intend to do with it, or whether a commercial order is likely to follow. Instead of rushing to ship samples, it’s usually more valuable to clarify the buyer’s requirements first. ...
- Source: drugdu
- 132
- September 18, 2026
【EXPERT Q&A】How are in vitro diagnostic kits developed?

Drugdu.com expert’s response: The R&D of in vitro diagnostic kits is a rigorous and standardized full-process system, with 5 core key stages that ultimately produce safe and effective products complying with regulatory requirements. Stage 1: Project Initiation and Preparation Clarify the target analyte to be tested, intended use and application scenarios, and complete research on market capacity, competing products and clinical demands. Confirm technical feasibility through literature review, form the project team, and prepare the project initiation assessment document for review and approval. Define core indicators such as product performance parameters and intended use, complete design input, and form the product summary materials required for registration. Stage 2: Product Development Raw material screening: Select no less than 3 qualified suppliers to ensure the quality of core raw materials (antigens, antibodies, primers, probes, etc.) is stable and traceable. Process and system optimization: Determine key parameters such as reagent formulation ratio, reaction ...
- Source: drugdu
- 89
- September 16, 2026
【EXPERT Q&A】What is the process for applying for a medical device registration certificate?

Drugdu.com expert’s response: The application for a Medical Device Registration Certificate generally does not start with “preparing documents”. Instead, the first step is to confirm exactly which risk class the product belongs to. In China, medical devices are categorized into Class I, Class II and Class III based on their risk levels. Class I devices are subject to record-filing management, while the registration certificate application process is usually required only for Class II and Class III devices. Therefore, before formally launching the application, enterprises must first complete product classification judgment, confirming the product name, structural composition, intended use, working principle and risk level, to avoid taking a wrong path in subsequent tests, clinical evaluation and declaration. After the classification is confirmed, the enterprise needs to clarify the registration applicant and the production arrangement. That is to confirm who acts as the registration applicant, who is responsible for production, whether entrusted ...
- Source: drugdu
- 89
- September 14, 2026
【EXPERT Q&A】How should one apply for a medical device license (Class III)?

Drugdu.com expert’s response: For trading companies and distributors that sell Class III medical devices, it is the Class III Medical Device Business License that they need to apply for. For manufacturers, the required qualifications are the Medical Device Production License and the product-specific Medical Device Registration Certificate, and these two sets of qualifications must not be confused. The general application process for the Class III Medical Device Business License is as follows: Confirm that the product falls into the Class III category: Look up the medical device classification and corresponding classification coding of the target product first. Different products correspond to different business scope entries, and this step will directly affect the subsequent requirements for personnel, business premises and warehousing conditions. Prepare the required operating conditions: The enterprise needs to have a business premises that matches its operating scale, qualified quality management personnel, complete quality management rules and a computer ...
- Source: drugdu
- 91
- September 11, 2026

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