Expert Q&A – Page 13 – media

【EXPERT Q&A】Which is purer, veterinary or generic?

Drugdu.com expert’s response: The purity of veterinary drugs and generic drugs cannot be generalized, as their purity is influenced by multiple factors, including production processes, raw material quality, and quality control standards. Below is a detailed analysis of the purity of veterinary drugs and generic drugs: I. Purity of Veterinary Drugs Definition and Purpose of Veterinary Drugs: Veterinary drugs refer to substances used for preventing, treating, and diagnosing animal diseases or intentionally regulating animal physiological functions. Purity Requirements: Veterinary drugs must meet the purity requirements stipulated in the national veterinary pharmacopoeia or relevant standards. Typically, the production of veterinary drugs undergoes strict quality control, including raw material screening, production process optimization, impurity control, and other aspects, to ensure product purity. Influencing Factors: The purity of veterinary drugs can be affected by production processes, raw material quality, storage conditions, and other factors. Therefore, these factors need to be strictly controlled during ...
- Source: drugdu
- 203
- January 10, 2025
【EXPERT Q&A】What qualifications do trading companies need to export apis?

Drugdu.com expert’s response: Export Requirements for Pharmaceutical Raw Materials by Trading Companies： I. Basic Qualifications Import and Export Rights: According to the relevant provisions of the “Regulations of the People’s Republic of China on the Administration of Import and Export of Goods,” foreign trade companies need to obtain import and export rights, which are the basic qualification for conducting international trade. Pharmaceutical Business License: Foreign trade companies must possess a legal pharmaceutical business license to purchase and export from domestic pharmaceutical enterprises or drug trading enterprises. If the foreign trade company itself engages in the production of pharmaceutical raw materials, it also needs to hold a valid pharmaceutical production license. Dangerous Goods Business License: Since pharmaceutical raw materials often fall into the category of dangerous goods, foreign trade companies need to hold a dangerous goods business license to comply with the “Regulations on the Administration of Safety of Dangerous Chemicals.” ...
- Source: drugdu
- 404
- January 8, 2025
【EXPERT Q&A】What are Germany’s measures on drug control?

Drugdu.com expert’s response: Here is the English translation of the detailed summary of Germany’s measures for pharmaceutical regulation: Germany’s Measures for Pharmaceutical Regulation Germany’s measures for pharmaceutical regulation cover multiple aspects to ensure the safety, effectiveness, and accessibility of pharmaceuticals. The following is a detailed summary of Germany’s pharmaceutical regulation measures: Ⅰ. Pharmaceutical Management System Germany implements a joint regulatory system for the production and circulation of pharmaceuticals through federal and state pharmaceutical regulatory authorities. Federal Pharmaceutical Regulatory Authorities: These include the Federal Ministry of Health and Social Security, the Federal Institute for Drugs and Medical Devices (BfArM), the Federal Serum and Vaccine Institute, and the Federal Institute for Consumer Health Protection and Veterinary Medicine. Their main tasks include accepting pharmaceutical registration applications, issuing marketing authorization for pharmaceuticals, testing sera, vaccines, and experimental allergens, compiling pharmacopoeias, and issuing recall directives for pharmaceuticals suspected of having adverse health effects. State Pharmaceutical ...
- Source: drugdu
- 222
- January 6, 2025
【EXPERT Q&A】What is the difference between the European Drug Master File (EDMF) and the US DMF?

Drugdu.com expert’s response: The European Drug Master File (EDMF) and the United States Drug Master File (DMF) both comprehensively represent aspects of pharmaceutical production and quality, but due to their targeting of different markets, there are certain differences between them. Below is a detailed comparison of the two: Ⅰ. Structure and Content EDMF: Consists of four parts: EDMF Public Part, Confidential Part, Quality Overview Summary (QOS) Public Part, and QOS Confidential Part. The contents of these four parts overlap, but for the same content, the degree of description differs among the parts. For example, all four parts contain process descriptions, but only the Confidential Part includes the complete process, while the others only provide a brief overview of the process. DMF: Comprises a single, comprehensive document without the clear sub-division seen in the EDMF. The content is relatively concentrated, covering detailed information on pharmaceutical production, quality, and other aspects. Ⅱ. Quality Reference ...
- Source: drugdu
- 486
- January 3, 2025
【EXPERT Q&A】What qualifications do you need to export Class II medical devices to Japan?

Drugdu.com expert’s response: Exporting Class II Medical Devices to Japan requires compliance with Japan’s Pharmaceutical and Medical Device Act (PMD Act). Here are the primary qualifications and steps required: Determining Product Classification and JMDN Code: According to the PMD Act, medical devices are classified into I, II Special Control, II Controlled, III, and IV categories. It is necessary to determine the specific classification and JMDN code for the exported Class II medical devices. Manufacturer Registration: Foreign manufacturers must register their manufacturer information with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), including details on product design, production, and key processes. QMS Factory Audit: For Class II Special Control products, an application for a Quality Management System (QMS) factory audit must be submitted to the authorized certification body, PCB. For other Class II products, as well as Class III and IV products, an application for a QMS factory audit must be submitted ...
- Source: drugdu
- 416
- January 1, 2025
【EXPERT Q&A】What is the meaning of the red list, yellow list and green list involved in FDA import alerts?

Drugdu.com expert’s response: The import alert system of the FDA (Food and Drug Administration) is a crucial means for it to ensure the safety of imported products, particularly foods, drugs, cosmetics, medical devices, and more. Among them, the red list, yellow list, and green list are ways used by the FDA to indicate the compliance status of different categories of products. Below are their specific meanings in English: Ⅰ. Red List Definition: The red list represents the strictest warning, indicating that the product or manufacturer has serious compliance issues, often due to the product failing FDA inspections or tests. Characteristics: Once a product is placed on the red list, it will face automatic detention until the manufacturer, shipper, grower, or importer proves to the FDA that the violations have been corrected. This detention occurs without the need for FDA to inspect, examine, or sample the product, also known as “Detention ...
- Source: drugdu
- 362
- December 30, 2024
【EXPERT Q&A】What information should be prepared for medical device export?

Drugdu.com expert’s response: Exporting medical devices requires a series of documents to ensure the legitimacy and safety of the products, as well as compliance with the relevant regulations and requirements of the importing country. Below is a detailed list of required documents: Ⅰ. Corporate Qualification Documents Business License: Certifies that the exporting enterprise has legal operating qualifications. Medical Device Operation License: If the enterprise engages in medical device operations, it must provide a Medical Device Operation License issued by the National Medical Products Administration. However, please note that for certain categories of medical devices, if their safety and effectiveness are not affected by the distribution process, they may be exempt from operation registration. Medical Device Production License: If the enterprise produces medical devices itself, it must provide this license to prove its qualification to produce medical devices. Identification Documents of the Legal Representative or Business Responsible Person: Provide copies of ...
- Source: drugdu
- 194
- December 27, 2024
【EXPERT Q&A】Do fascia guns need to be certified as medical devices in Japan?

Drugdu.com expert’s response: Whether a fascia gun needs to undergo medical device certification in Japan mainly depends on its market positioning and product category. I. Market Positioning of Fascia Guns in Japan There are two different product definitions for fascia guns in the Japanese market: Ordinary Household Products: If fascia guns are exported to Japan as ordinary household products, they are not required to undergo mandatory medical device certification and can be sold directly in the Japanese market. Medical Devices: If fascia guns are defined as medical devices and exported to Japan, they will need to undergo medical device certification. In this case, the product’s added value may increase and it may become more favored by the Japanese market. According to the regulations of the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, fascia guns classified as medical devices fall under “designated controlled” products. II. Certification Process for Medical Devices ...
- Source: drugdu
- 348
- December 25, 2024
【EXPERT Q&A】What is the development process of a qualified medical device?

Drugdu.com expert’s response: The development process of a qualified medical device typically includes the following key steps: Ⅰ. Preliminary Preparations Business Registration: Register the company and clarify the business scope to prepare for future product production ranges and avoid subsequent changes. Team Formation: Establish a professional and efficient R&D team, including talents in mechanical engineering, electrical engineering, software engineering, etc., to ensure the technical feasibility of the product. Ⅱ. Product Development and Design Product Requirement Determination: Conduct market research, clinical application scenario analysis, doctor visits, etc., by the product manager to clarify the product’s functional requirements, performance requirements, and user expectations. System Requirement Determination: Convert product requirements into engineering technical indicators, complete the division of system functional architecture and constituent components, and output related requirements for regulations and standards, risk and safety, usability, serviceability, and manufacturability. R&D and Design: Based on system requirements, carry out structural design, sampling verification, and ...
- Source: drugdu
- 255
- December 23, 2024
【EXPERT Q&A】What are the content requirements of the medical device Post-marketing Supervision Plan (PMS Plan) required by the EU CE?

Drugdu.com expert’s response: The Post-Market Surveillance (PMS) Plan for medical devices required by the EU CE is a comprehensive strategic document aimed at ensuring the continued safety, effectiveness, and compliance of medical devices after they have been released to the market. The core content of this plan revolves around the following aspects, aiming to establish a comprehensive and responsive surveillance system: Firstly, defining objectives and scope. The PMS Plan must clearly outline its objectives, which are to ensure the safety and effectiveness of medical devices during use while minimizing potential risks. It should encompass all key stakeholders, including manufacturers, distributors, users, and regulatory authorities, and be applicable to various types of medical devices, both for home use and professional purposes. Secondly, establishing a data collection and analysis mechanism. The plan requires the creation of an efficient data collection system to capture information from multiple sources, such as sales data, user ...
- Source: drugdu
- 240
- December 20, 2024

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