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Related Concept Videos

Drug Regulation01:25

Drug Regulation

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Pharmacovigilance01:19

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
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Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
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Preclinical Development: Overview01:28

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Clinical Trials: Overview01:11

Clinical Trials: Overview

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Mitral Stenosis III: Medical Management01:26

Mitral Stenosis III: Medical Management

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Mitral stenosis, a condition marked by the narrowing of the mitral valve, necessitates an integrated approach for effective management. This approach includes preventative measures, medical therapy, and surgical interventions to reduce symptoms and prevent complications.PreventionPrevention of mitral stenosis primarily focuses on reducing the incidence of bacterial infections, particularly streptococcal infections, which can lead to rheumatic fever and subsequent valvular damage. Timely...
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Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices
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[Approval Status and Suggestions on Supervision of Class II Innovative Medical Device].

Shimei Duan1, Zhizhen Zhong1

  • 1Shanghai Medical Device and Cosmetics Evaluation and Verification Center, Shanghai, 200020.

Zhongguo Yi Liao Qi Xie Za Zhi = Chinese Journal of Medical Instrumentation
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Summary

This study analyzes challenges in approving innovative medical devices and proposes improvements for regulatory systems, review processes, and clinical trial strategies to facilitate market access.

Keywords:
approvalinnovative medical devicesupervision

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Area of Science:

  • Medical device regulation
  • Health policy
  • Regulatory science

Context:

  • Current landscape of class II innovative medical device approval and publicity across provinces and cities.
  • Analysis of specific review problems encountered with class II innovative medical devices in Shanghai.
  • Identification of factors influencing the market listing process for innovative medical devices.

Purpose:

  • To provide insights for improving the regulatory framework and systems for innovative medical devices.
  • To suggest changes in the review and approval thinking for medical devices.
  • To guide the extension of services supporting innovative medical device development and clinical trial design.

Summary:

  • Examines the current state of class II innovative medical device approvals, highlighting issues identified in Shanghai's review process.
  • Investigates factors impeding the market entry of innovative medical devices.
  • Offers recommendations for enhancing regulatory oversight, adapting review methodologies, and supporting device innovation.

Impact:

  • Aims to inform the establishment and refinement of regulations and systems governing innovative medical devices.
  • Facilitates a more efficient and effective pathway for innovative medical devices to reach the market.
  • Contributes to the advancement of medical device innovation through improved regulatory support and clinical trial planning.