Expert Q&A – Page 2 – media

【EXPERT Q&A】Do I need a registered clinical trial for 3D endoscopy?

Drugdu.com expert’s response: Three-dimensional endoscopes typically require registration clinical trials, but the specifics of whether they are conducted and the requirements for clinical trials may vary based on product characteristics, registration region, and regulatory requirements. Ⅰ. Clinical Trial Requirements for Three-dimensional Endoscopes Regulatory Requirements: According to the relevant regulations of the National Medical Products Administration, medical devices generally need to provide clinical trial data during registration to prove their safety and effectiveness. As a type of medical device, three-dimensional endoscopes have certain complexity and risk in their design and use, thus usually requiring clinical trials to assess their performance. Product Characteristics: Three-dimensional endoscopes feature three-dimensional imaging capabilities, providing a more three-dimensional surgical view and aiding doctors in making more accurate judgments and operations. However, this new technology may also bring some unknown risks and side effects, which need to be discovered and assessed through clinical trials. Registration Region Differences: Different countries and regions may ...
- Source: drugdu
- 65
- October 28, 2024
【EXPERT Q&A】What is the role of the Drug Administration Act in ensuring the quality and safety of drugs?

Drugdu.com expert’s response: The “Pharmaceutical Administration Law of the People’s Republic of China” plays a crucial role in ensuring the quality and safety of drugs. Here are several key aspects of its role in this regard: Ⅰ. Defining and Classifying Drugs Article 2 of the Pharmaceutical Administration Law clearly stipulates that the drugs referred to in this Law are substances used for the prevention, treatment, and diagnosis of human diseases, for the purposeful regulation of human physiological functions, and with specified indications or functional indications, usage, and dosage, including traditional Chinese medicines, chemical drugs, and biological products. This definition clarifies the scope and classification of drugs, providing a legal foundation for subsequent regulatory work. Ⅱ. Establishing Strict Regulations for Drug Research and Development, Production, Operation, and Use Research and Development: Article 29 of the Pharmaceutical Administration Law stipulates that the research and development of new drugs must be conducted in accordance ...
- Source: drugdu
- 81
- October 25, 2024
【EXPERT Q&A】What is the process for registering apis in Saudi Arabia?

Drugdu.com expert’s response: Ⅰ. Preliminary Preparation and Research Before initiating the registration process, you need to: Conduct in-depth market research: Study the pharmaceutical market in Saudi Arabia to understand local demand for APIs, market size, and potential growth opportunities. Technical assessment: Evaluate whether your API product meets the quality and technical standards of Saudi Arabia. This includes assessments of production processes, quality control, stability, and other aspects. Regulatory familiarization: Thoroughly familiarize yourself with the registration requirements and processes of the Saudi Food and Drug Authority (SFDA) to ensure your product meets all relevant regulations. Ⅱ. Document Preparation and Submission Prepare registration documents: According to SFDA requirements, prepare complete registration documents, including product specifications, production process descriptions, quality control documents, stability study data, etc. Translation and notarization: If your documents are not in Arabic, they need to be translated into Arabic and notarized. Submit the application: Submit the registration application and ...
- Source: drugdu
- 68
- October 23, 2024
【EXPERT Q&A】What is the process for medical device export?

Drugdu.com expert’s response: The process of exporting medical devices involves multiple steps, as detailed below: Ⅰ. Market Research and Preparation Target Market Research: Conduct in-depth research on the medical device demand, regulations, standards, and competitors in the target market. Understand factors that may affect transactions, such as the target market’s political stability, trade policies, and currency exchange rate fluctuations. Product Registration and Certification: Complete product registration and certification according to the regulatory requirements of the target market. For example, the European market requires CE certification, and the US market requires FDA registration. Ensure that the products comply with the regulations and standards of the destination country to avoid trade barriers and compliance risks. Establishing a Sales Network: Establish contact with distributors, agents, or medical institutions in the target market. Participate in international exhibitions, seminars, and other events to communicate face-to-face with potential customers and showcase product advantages. Ⅱ. Production and ...
- Source: drugdu
- 86
- October 21, 2024
【EXPERT Q&A】What are the certification requirements for WC?

Drugdu.com expert’s response: WC, fully known as Written Confirmation, is a requirement for non-EU countries exporting Active Pharmaceutical Ingredients (APIs) to the EU market. The certification requirements for WC can be elaborated from the following aspects: I. Certification Authority and Document Issuance The WC certification document is an official document issued by the pharmaceutical regulatory authority of the API-producing country. This document certifies that the exported APIs comply with the Good Manufacturing Practice (GMP) standards of the EU. II. Application Conditions and Prerequisites Prerequisites: Pharmaceutical GMP certification involves rigorous audits of a manufacturer’s quality management system, production processes, equipment, and personnel to ensure that the drugs produced meet the relevant quality and safety requirements of the EU. Only enterprises that have passed GMP certification can obtain WC documents to export APIs to the EU market. Application Conditions: These typically include production licenses, descriptions of the quality management system, product details, ...
- Source: drugdu
- 82
- October 18, 2024
【EXPERT Q&A】What certification is required for drug export to Vietnam?

Drugdu.com expert’s response: Exporting pharmaceutical products to Vietnam requires a series of certifications to ensure compliance with Vietnamese regulations and legal sale in the Vietnamese market. Here are the primary certification requirements: Ⅰ. Free Sales Certificate (FSC) from the Drug Regulatory Authority and Vietnam Embassy Authentication Free Sales Certificate (FSC) from the Drug Regulatory Authority: Definition: The Free Sales Certificate, also known as the Export Sales Certificate, is an official document issued by the drug regulatory authority, certifying that a particular pharmaceutical product or medical device meets relevant national standards and directives, allowing its free sale within the country and export to other countries. Role: In international trade, the FSC is a crucial document for enhancing a product’s international competitiveness, particularly when exporting to overseas markets like Vietnam, where it validates the legality and quality of the pharmaceutical products. Vietnam Embassy Authentication: Definition: Vietnam Embassy Authentication is an official certification ...
- Source: drugdu
- 73
- October 16, 2024
【EXPERT Q&A】What are the precautions for import and export goods entering and leaving the customs?

Drugdu.com expert’s response: When importing and exporting goods through customs, various aspects need to be taken into consideration to ensure smooth customs clearance and compliance with relevant regulations. Here are some key considerations: Ⅰ. Documentation Preparation Complete and Accurate Documentation: Import-export enterprises must prepare complete documents, including bills of lading, invoices, packing lists, contracts, import-export licenses (if required), certificates of origin, inspection and quarantine certificates, etc. These documents must be accurate and in line with customs requirements. Compliant Declaration: Ensure that the declared information for goods is accurate, including commodity names, quantities, values, origins, etc. The declared value should match the actual value to avoid issues arising from over- or under-declaration. Ⅱ. Commodity Classification and Taxation Accurate Classification: Accurate classification of goods is crucial, as it directly determines the Harmonized System (HS) code, which further influences tariff rates and regulatory conditions. Misclassification can lead to unnecessary troubles and losses. Tax ...
- Source: drugdu
- 66
- October 14, 2024
【EXPERT Q&A】Can metformin fight aging?

Drugdu.com expert’s response: Metformin, a widely used antidiabetic drug, has shown potential in recent research on anti-aging. Specifically, its anti-aging effects are manifested in the following aspects: Ⅰ. Scientific Research Achievements Research by the Chinese Academy of Sciences Team: After an extensive 8-year study, the team led by Liu Guanghui from the Institute of Zoology, Chinese Academy of Sciences, discovered that metformin can reset the intrinsic program of cellular aging, significantly delaying aging in primates. This achievement was published in the journal “Cell”, providing new insights into the biological mechanisms of aging and potential strategies for future interventions in human aging. Experimental Evidence: The research team conducted a 40-month follow-up study on middle-aged and elderly male crab-eating macaques. The results showed that individuals who took metformin long-term exhibited significant delays in aging, including reduced brain cortex atrophy, improved cognitive function, delayed periodontal bone degeneration, and protection of multiple tissues and ...
- Source: drugdu
- 71
- October 11, 2024
【EXPERT Q&A】What is the South African drug export registration process?

Drugdu.com expert’s response: The process of exporting and registering pharmaceutical products in South Africa is a relatively complex and meticulous endeavor, involving multiple stages and documentation requirements. Here is an overview of the process: Ⅰ. Preliminary Preparation Product Classification: Firstly, it is crucial to determine the classification of the pharmaceutical product in South Africa, as different classifications may entail different registration requirements and procedures. Preparation of Technical Documentation: This typically includes detailed information about the product, such as its composition, indications, dosage form, quality standards, as well as technical specifications, design descriptions, and performance test results that demonstrate the product’s safety, efficacy, and performance. Collection of Clinical Data: Depending on the requirements, relevant clinical data must be provided to support the product’s clinical performance and effectiveness. This may encompass clinical trial results, case studies, literature reviews, etc. Corporate Qualification: Ensure that the exporting company has a legal registration status in ...
- Source: drugdu
- 86
- October 9, 2024
【EXPERT Q&A】How to obtain the 510K number for medical device export to the United States?

Drugdu.com expert’s response: Exporting medical devices to the United States and obtaining a 510K number involves adhering to the regulations and procedures set forth by the U.S. Food and Drug Administration (FDA). Ⅰ. Understanding the Basics of 510K 510(k) is a premarket notification program established by the FDA, named after Section 510(k) of Chapter 21 of the Federal Food, Drug, and Cosmetic Act. This program requires manufacturers to submit a “510(k) Premarket Notification” to the FDA before introducing a new medical device or making significant modifications to an existing one and reintroducing it to the market. The purpose of this submission is to demonstrate that the newly developed medical device is substantially equivalent in safety and effectiveness to a similar device that has already been approved by the FDA. Ⅱ. Determining Product Classification First, it is essential to determine the classification of the medical device. The FDA categorizes medical devices ...
- Source: drugdu
- 85
- October 7, 2024

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