Expert Q&A – media

【EXPERT Q&A】What are the differences between generic drugs and original drugs?

Drugdu.com expert’s response: Detailed Comparison Between Generic Drugs and Originator Drugs I. Definition and Background Originator Drugs: These are innovative drugs that are originally researched and developed by companies that hold the patent rights for the medication. These new drugs typically undergo long-term safety evaluations and complete Phase I to III (and sometimes Phase IV) clinical trials, followed by continuous post-marketing monitoring of their efficacy. The research and development (R&D) of originator drugs are usually initiated by large, financially strong pharmaceutical companies, taking up to fifteen years from R&D to market launch, with costs reaching billions of dollars. Generic Drugs: These are drugs that are developed after the patent protection period (typically 20 years) of an originator drug expires, based on research into the main active ingredient of the originator drug. The R&D process for generic drugs is relatively straightforward, involving the replication of the main molecular structure of the ...
- Source: drugdu
- 34
- February 7, 2025
【EXPERT Q&A】What are the requirements of EU medical device CE audit for quality management system document control?

Drugdu.com expert’s response: The CE certification requirements for medical devices in the European Union (EU) are quite stringent in terms of quality management system (QMS) document control. Below is an overview of the specific requirements: I. Content and Requirements of QMS Documents Completeness: The QMS documents should include policies, procedures, guidelines, forms, records, etc., comprehensively covering all aspects of the quality management system. These documents need to detail and prove that the product complies with EU regulations and standards, including but not limited to product design descriptions, performance test reports, risk assessment reports, biocompatibility assessment reports, electromagnetic compatibility test reports, etc. Accuracy: The information in technical documents must be accurate and capable of truthfully reflecting the technical characteristics and safety performance of the product. Traceability: The QMS documents should ensure the traceability of product quality, including raw material sources, production processes, quality control, and other links. Continuous Improvement: The QMS ...
- Source: drugdu
- 40
- February 5, 2025
【EXPERT Q&A】Do IVD clinical trials need to include interference samples?

Drugdu.com expert’s response: The inclusion of interference samples is necessary in IVD (in vitro diagnostic) clinical trials. According to the requirements of the Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents, subjects enrolled should be considered for inclusion of samples that may interfere with the test. This requirement aims to ensure the accuracy and reliability of IVD reagents in clinical use by evaluating their performance under complex conditions through the inclusion of interference samples. In practical operations, the selection and preparation of interference samples need to follow certain methods. For example, samples near the upper and lower limits of the reference range and medical decision levels can be selected as test samples, with hemoglobin, rheumatoid factor, and other interferents added to clinical samples. The volume of added interferents should generally not exceed a certain proportion of the total sample volume to ensure the validity of the test. In addition, ...
- Source: drugdu
- 45
- February 3, 2025
【EXPERT Q&A】What certifications are required for pharmaceutical exports to Saudi Arabia?

Drugdu.com expert’s response: For the export of pharmaceuticals to Saudi Arabia, the following certifications are mandatory: I. SFDA Certification Definition: SFDA certification refers to the certification of the Saudi Food and Drug Authority (SFDA). SFDA is responsible for regulating and managing the safety, quality, and effectiveness of products such as food, drugs, medical devices, and cosmetics to safeguard public health and safety. Importance: SFDA certification is essential for selling pharmaceutical products in the Saudi market. Products without SFDA certification cannot be legally sold. Only after obtaining SFDA certification can products be legally sold and used in the Saudi Arabian market. Application Process: Prepare product descriptions, technical specifications, manufacturing processes, quality management system documents, etc., for submission of the SFDA certification application. Select a qualified certification body (usually a third-party organization) to conduct product testing and evaluation, ensuring that the body has the appropriate experience and qualifications in SFDA certification. Submit ...
- Source: drugdu
- 57
- January 31, 2025
【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
- 80
- 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
- 73
- 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
- 75
- 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
- 69
- 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
- 101
- 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
- 94
- January 17, 2025

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