Expert Q&A – Page 4 – media

【EXPERT Q&A】Does European GPSR compliance require CE certification?

Drugdu.com expert’s response: Happy Chinese New Year! Detailed Analysis on the Relationship Between GPSR Compliance and CE Certification in Europe I. Concepts and Relationship Between GPSR and CE Certification GPSR (General Product Safety Regulation): It is a regulation of the European Union concerning the general safety of products, aiming to ensure that products placed on the EU market are safe under normal or reasonably foreseeable conditions of use. It covers a wide range of product categories, including toys, electrical appliances, and various consumer goods, requiring products to meet corresponding safety, health, and environmental standards. CE Certification: It constitutes the “essential requirements” of European directives and is considered as the “passport” for manufacturers to enter the European market. It indicates that the product complies with the basic requirements of the EU’s “New Approach to Technical Harmonization and Standardization” directives, involving mechanical safety, electromagnetic compatibility, low-voltage safety, and other aspects. Relationship: Partial ...
- Source: drugdu
- 135
- January 29, 2025
【EXPERT Q&A】How effective is Telitacicept?

Drugdu.com expert’s response: Telitacicept, a novel fusion protein drug for the treatment of autoimmune diseases, has demonstrated its therapeutic efficacy in multiple clinical trials, as detailed below: I. Main Therapeutic Indications and Effects Systemic Lupus Erythematosus (SLE) Telitacicept alleviates SLE symptoms by inhibiting the overactivation of B cells. Clinical trial data indicate that over 60% of patients using Telitacicept experienced significant improvement in their condition, specifically evident in the relief of skin, joint, and kidney symptoms. A multicenter, randomized, double-blind, placebo-controlled pivotal clinical study showed that the 48-week response rate in the high-dose Telitacicept group was 79.2%, significantly higher than the 32.0% in the placebo control group. Another nationwide multicenter, randomized, double-blind, placebo-controlled Phase IIb drug study showed that the Telitacicept 160mg dose group (the standard dose approved for marketing in China) had significantly higher response rates than the placebo group from Week 12 onwards, and the efficacy advantage persisted ...
- Source: drugdu
- 107
- January 27, 2025
【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
- 107
- 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
- 116
- 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
- 149
- 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
- 139
- 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
- 114
- 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
- 131
- 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
- 125
- 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
- 197
- January 8, 2025

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