Expert Q&A – media

【EXPERT Q&A】What are the legal provisions related to drug patents?

Drugdu.com expert’s response: The legal provisions related to pharmaceutical patents mainly include the following laws and regulations: I. Patent Law of the People’s Republic of China Scope of Patent Protection: According to the Patent Law, the scope of patent protection for pharmaceuticals encompasses patents for new drugs, new preparation methods, and new uses. This includes but is not limited to new compounds, pharmaceutical compositions, new microbial and genetic engineering products, new isomers, new effective crystalline forms, etc. Utility model patents also involve improvements in shape and structure related to the function of pharmaceuticals, while design patents pertain to the appearance and packaging of pharmaceuticals. Patent Term and Compensation: The term of invention patents is twenty years. For invention patents related to new drugs that obtain marketing authorization in China, the patent term may be compensated for the time taken up by review and approval, but the total effective patent term after compensation shall ...
- Source: drugdu
- 34
- January 20, 2025
【EXPERT Q&A】What information should be provided for the analytical performance evaluation data of in vitro diagnostic reagent products?

Drugdu.com expert’s response: The analytical performance evaluation documents of in vitro diagnostic reagent products are crucial files ensuring the quality and accuracy of reagent products. To comprehensively evaluate the analytical performance of reagent products, the following information is typically required: I. Basic Information Registrant Name: Clarifies the responsible entity for easy traceability by regulatory authorities. Product Name: Ensures the accuracy of the reagent product being evaluated. II. Performance Evaluation Scheme and Requirements Evaluation Method: Detailed description of the adopted evaluation method, including experimental design, operational steps, etc. Evaluation Requirements: Clearly defined evaluation standards and judgment criteria. III. Reagent Information Name, Batch Number, Expiry Date: These details facilitate tracing the reagent’s source and quality, ensuring the evaluated reagent is within its validity period and of stable quality. Calibrator and Control Material Information: If calibrators and control materials are used, their relevant information should also be provided to ensure the accuracy and ...
- Source: drugdu
- 41
- January 17, 2025
【EXPERT Q&A】What requirements should be paid attention to for the EU CE registration of “medical device equivalent certificate”?

Drugdu.com expert’s response: In the process of EU CE registration, regarding the “Proof of Medical Device Equivalence,” manufacturers should pay attention to the following requirements: I. Determination of Equivalent Devices Selection of Equivalent Devices: Manufacturers can identify one or more devices that are equivalent to the device under assessment, but each equivalent device should be equivalent to the device under assessment in all listed technical, biological, and clinical characteristics. Proof of Equivalence: The equivalence of each equivalent device should be thoroughly investigated, described, and proven in the clinical evaluation report. Manufacturers cannot use different components of different devices to claim equivalence with the device under assessment. Gap Analysis: Manufacturers should conduct a gap analysis to assess all clinically significant differences and determine whether the device, in terms of its safety, technical, biological, and clinical characteristics under the Medical Device Regulation (MDR), has the same or similar clinical performance as the ...
- Source: drugdu
- 44
- January 15, 2025
【EXPERT Q&A】What are the storage conditions for in vitro diagnostic reagents stability study?

Drugdu.com expert’s response: The requirements for storage conditions in stability studies of in vitro diagnostic reagents are as follows: I. Specific Requirements for Storage Conditions Temperature Conditions: The suitable storage temperature of the product must be described in detail in the product insert, for example, the common refrigerated condition is between 2°C and 8°C, or the frozen condition is below -18°C. Avoid using uncertain terms such as “refrigerated”, “frozen”, or “room temperature” to describe the storage temperature. If the stability of the product changes after the packaging is opened, it is necessary to specifically indicate the storage temperature conditions that the product or its components should follow after opening. Other Environmental Factors: In addition to temperature conditions, it is also necessary to specify other factors that may affect the stability of the product, such as whether it needs to be stored away from light, as well as requirements for humidity, moisture protection, shock ...
- Source: drugdu
- 56
- January 13, 2025
【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
- 56
- 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
- 61
- 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
- 59
- 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
- 202
- 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
- 85
- 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
- 87
- December 30, 2024

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