Expert Q&A – Page 9 – media

【EXPERT Q&A】What are the requirements for conducting clinical trials of medical devices?

Drugdu.com expert’s response: Here is the English translation of the provided text: Conducting medical device clinical trials must meet a series of stringent requirements to ensure the scientific, ethical, and safe conduct of the trials. Based on relevant regulations and norms, the following are the key requirements: Ethical Committee Approval Medical device clinical trials must obtain approval from an ethical committee. The ethical committee evaluates the ethical and moral aspects of the trial to ensure that it does not pose unnecessary risks to participants. Planning and Design The trial should have a detailed plan and design, including research objectives, methods, recruitment and inclusion criteria, exclusion criteria, etc., to ensure the scientific and reliable conduct of the trial. Participant Recruitment and Informed Consent The recruitment process for trial participants must be clearly defined, including the source of participants, recruitment methods, and how to obtain their informed consent. Participants must fully understand the ...
- Source: drugdu
- 253
- January 24, 2025
【EXPERT Q&A】Why does IVD analysis performance evaluation require the use of samples from different sources for research?

Drugdu.com expert’s response: In the analytical performance evaluation of IVD (In Vitro Diagnostics), the requirement to use samples from different sources for research is primarily based on the following considerations: I. Influence of Matrix Effects For IVD products, the detection targets are typically human tissues or fluids, particularly liquid samples such as blood and urine. These samples contain various substances such as salts, proteins, lipids, etc., which collectively constitute the matrix of the sample. Different human samples, or even samples from the same individual at different time points, may exhibit variations in their matrices. This matrix variation can impact the test results of reagents, known as matrix effects. Matrix effects are objectively present but can be controlled through scientific methods. Therefore, when conducting analytical performance evaluations of IVD products, it is necessary to use samples from different sources as much as possible to fully consider the impact of matrix effects ...
- Source: drugdu
- 249
- January 22, 2025
【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
- 275
- 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
- 276
- 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
- 157
- 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
- 188
- 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
- 171
- 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
- 357
- 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
- 194
- 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
- 451
- January 3, 2025

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