Expert Q&A – Page 20 – media

【EXPERT Q&A】What is the FDA’s drug approval process?

Drugdu.com expert’s response: The FDA drug approval process is both standardized and rigorous. Here’s a detailed breakdown of the entire process: 1.Preclinical Research: This is the first step in the drug approval process. It includes pharmacological and toxicological studies to evaluate the safety and effectiveness of the drug. These studies are usually conducted in laboratories or on animal models. 2.Submission of Investigational New Drug (IND) Application: Once the data from preclinical studies suggest that the drug might be safe, the pharmaceutical company submits an Investigational New Drug (IND) application. The IND contains data from preclinical studies, manufacturing information, clinical trial protocols, and more. 3.Clinical Trials: This is the heart of the drug approval process and it typically encompasses three phases. Phase I primarily tests the drug’s safety and dosage in humans. Phase II focuses on its effectiveness and side effects. Phase III further verifies its effectiveness, monitors side effects, and compares ...
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- August 15, 2023
FDA drug approval
【EXPERT Q&A】What might be the reasons for not closing deals despite following up with many clients?

Drugdu.com expert’s response: For foreign trade salespeople, every inquiry received is hard-won and should be treasured. However, inevitably among these inquiries, there will be phishing emails, junk inquiries, and even more seriously, potential scammers. Therefore, upon receiving an email, the immediate response is not advisable. Instead, it’s essential first to discern and analyze. How to handle and reply to inquiries more effectively is the key to success. 1. Determine authenticity: 01 Check the IP: Check the sender’s IP by right-clicking the email, selecting properties-details to view the IP address of the email. Determine its geographical location. Also, cross-reference the IP records in the website counter to observe whether the visitor clicked a link to enter the website or typed in your URL directly. 02 Consider the sending time: Look at the email sending time and account for time zone differences. Generally, no one would send emails in the middle ...
- Source: drugdu
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- August 14, 2023
Foreign Trade Experience
【EXPERT Q&A】How to promote pharmaceutical intermediates?

Drugdu.com expert’s response: Promoting pharmaceutical intermediates essentially hinges on market positioning and the intended target audience. Here are some effective methods to promote pharmaceutical intermediates: 1.Participate in Professional Expos: This provides an excellent opportunity to meet potential clients and showcase your products. You can display product samples and engage in face-to-face business discussions. 2. Establish an Official Website: By setting up an official website, you can showcase your company’s capabilities, product details, and enhance your corporate image. 3. Online Marketing: For instance, post product information on industry-specific websites. Using Search Engine Optimization (SEO) and Search Engine Marketing (SEM) strategies can boost the online visibility of your products. 4. Cold-call Potential Customers: Take the initiative to reach out to companies that might be interested. This can be done via emails or phone calls. 5. Promote through Industry-specific Platforms: Drugdu.com is a dedicated platform for medical imports and exports. It caters to industry ...
- Source: drugdu
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- August 11, 2023
pharmaceutical intermediates
【EXPERT Q&A】Is it mandatory to conduct clinical trials for drug registration in India?

Drugdu.com expert’s response: Based on the years of experience from Drugdu.com, the number and cases of clinical trials conducted in India are related to the current clinical situation and whether the original research drug is marketed locally. Specific issues require case-by-case analysis. In general, for drug registration in India, if it is a chemical drug or a formulation, and the original research drug is already marketed in India, it can be registered as a generic drug in India, and clinical trials can be waived. Some orphan drugs, especially those that face recruitment challenges in clinical trials and are already marketed in the regulatory markets of Europe and the US, can also apply for exemption from local clinical trials. However, for biologics such as vaccines, monoclonal antibodies, and blood products, conducting phase III (bridging) clinical trials locally is mandatory for registration in India. Taking phase III clinical trials as an example, ...
- Source: drugdu
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- August 9, 2023
Clinical Trials drug registration
【EXPERT Q&A】How to ace the process of drug registration?

Drugdu.com expert’s response: Drug registration is a complex task that involves multiple steps. To do it well, you need to follow these steps: 1. Understand regulations and guidelines: Firstly, understand the related laws, guidelines, and policies of drug registration to ensure your product complies with the requirements of the country or region where it’s being registered. These laws and guidelines usually cover requirements for drug quality, safety, and efficacy. 2. Prepare registration materials: Prepare relevant registration materials according to the drug registration requirements of the country or region. These materials usually include the chemical, biological, and pharmacological properties of the drug, the drug development process, production technology, quality control, clinical trial data, drug labels, and instructions. Ensure the materials you submit are complete, accurate, and easy to understand. 3. Conduct clinical trials: In some cases, you may need to conduct clinical trials to prove the safety and effectiveness of the ...
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- May 31, 2023
【EXPERT Q&A】How to improve the response rate of emails for international trade development?

Drugdu.com expert’s response: Email marketing, as one of the essential tools for medical trade marketing, can significantly influence customer responses and even determine the success of your orders. Therefore, editing emails requires attention to detail and technique, as a small detail might prompt a customer to reply to your email. So, how can you write high-response-rate emails that make customers eager to reply? Deduo Medical Trade Network shares four essential email editing tips: Five times more people read email subject lines than the email body Readers usually judge whether to continue reading an email based on the subject line’s appeal, especially for customers who receive many emails every day. If your email subject line can grab the customer’s attention, you are already halfway successful. To increase the chances of customers opening your email, consider these three subject line patterns (use with caution as they may risk being marked as spam): 1.Imitate ...
- Source: drugdu
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- May 31, 2023
【EXPERT Q&A】What exactly is the difference between intermediates and active pharmaceutical ingredients?

Drugdu.com expert’s response: Both intermediates and active pharmaceutical ingredients (APIs) are chemical substances used in the pharmaceutical manufacturing process, but they serve different roles and purposes. An API refers to a chemical substance used to manufacture pharmaceutical products, typically obtained through chemical synthesis or natural extraction. APIs are the foundation of pharmaceutical manufacturing and are a crucial factor in determining the quality and efficacy of the drugs. APIs usually have specified chemical structures and purity requirements, therefore, the quality control and standard requirements for APIs are relatively high. Intermediates, on the other hand, are chemical substances used in the synthesis of APIs during the pharmaceutical manufacturing process. They are typically intermediate products obtained through multiple chemical reaction steps. Although intermediates themselves usually do not possess pharmacological activity, they play a significant role in pharmaceutical manufacturing, influencing the synthesis efficiency, quality, and cost of APIs, among other factors. Intermediates generally need ...
- Source: drugdu
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- May 31, 2023
【EXPERT Q&A】What are the market access requirements for medical devices entering the Ecuadorian market?

Drugdu.com expert’s response: The following are the market access requirements for medical devices entering the Ecuadorian market: Registration requirements: All medical devices must be registered with the National Agency for Regulation, Control, and Health Surveillance of Ecuador (ARCSA). Registration requirements include product technical documents, manufacturing license, quality management system, labels, instructions, and samples. License requirements: All medical devices require a medical device license in Ecuador to be sold in the market. The license application requirements include a registration certificate, manufacturing license, product instructions, and other relevant documents. Customs requirements: All imports of medical devices must comply with Ecuador’s customs regulations, including providing product information, product pricing, and the identity of the importer. Labeling requirements: All medical devices must have information such as the product name, usage, manufacturing date, expiration date, and the name and address of the manufacturer marked on the packaging. Ecuador’s medical device classification rules are based on ...
- Source: drugdu
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- May 31, 2023
【EXPERT Q&A】May I know if a registration certificate is required for the export of pharmaceuticals to the Democratic Republic of the Congo?

Drugdu.com expert’s response: Yes, a registration certificate is required for exporting pharmaceuticals to the Democratic Republic of the Congo. Congolese laws and regulations stipulate that the import of all pharmaceuticals must be authorized and registered by the local health authorities. The registration certificate for the pharmaceutical is a necessary document for entry into the country’s market. Therefore, if you wish to export pharmaceuticals to the Democratic Republic of the Congo, you need to obtain approval and a registration certificate from the Congolese health authorities. Additionally, the Democratic Republic of the Congo has stringent requirements for the quality and specifications of pharmaceuticals. The exported pharmaceuticals must meet local pharmaceutical laws and quality standards. If you are unfamiliar with the pharmaceutical regulations and registration requirements in the Democratic Republic of the Congo, it’s recommended that you consult local legal and trade professionals to ensure your export complies with local requirements and regulations. ...
- Source: drugdu
- 546
- May 30, 2023
What is the process for obtaining FDA certification in the United States?

Drugdu.com expert’s response: 1.Pre-Submission Consultation: This initial step often involves a formal or informal consultation with the FDA to discuss the product’s classification, the type of application needed, and data requirements. 2.Preparing Documentation: Following consultation, you’ll need to prepare all necessary documentation, which usually includes preclinical and clinical data, product information, manufacturing details, labeling, and more. The exact documentation needed will depend on the product classification and type of application. 3.Submission of Application: The next step is to submit your application or registration to the FDA. The type of application may include a Premarket Notification (510(k)), Premarket Approval (PMA), Investigational Device Exemption (IDE), or others, based on the product classification. 4.FDA Review: Once the FDA receives your application, they will conduct a review. This involves an assessment of all submitted materials and may include inspections, additional data requests, and more. 5.FDA Decision: After the review process, ...
- Source: drugdu
- 463
- May 30, 2023

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