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Drug Regulation01:25

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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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Drug Control Governance: Regulatory Bodies and Their Impact01:03

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Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
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Drugs can be classified according to their chemical composition or their intended therapeutic application. For instance, anti-infective agents that possess the ability to eliminate pathogens or suppress their growth and reproduction can be grouped based on the organisms they target or their chemical structure. Furthermore, drugs can be divided into prescription, nonprescription, or controlled substances. Prescription medications, such as antibiotics, require oversight from a licensed healthcare...
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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood or body tissues to tailor drug therapy effectively. This monitoring is critical for managing drugs with narrow therapeutic indices like digoxin and phenytoin, ensuring they are both safe and effective. For instance, monitoring theophylline levels in asthma patients involves precision and sensitivity to adjust doses according to individual responses to therapy, ensuring efficacy and...
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Formation of Dispersible Taohong Siwu Tablets
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Current controlled drug regulation in Taiwan.

Shiow-Ing Wu1, Wen-Ing Tsay1, Meng-Hsiu Wu1

  • 1Food and Drug Administration, Ministry of Health and Welfare, Taiwan, ROC.

Acta Anaesthesiologica Taiwanica : Official Journal of the Taiwan Society of Anesthesiologists
|June 10, 2015
PubMed
Summary

Taiwan

Area of Science:

  • Pharmacology
  • Public Health Policy
  • Drug Control Legislation

Background:

  • The management of controlled drugs is crucial for public health and safety.
  • International drug control treaties provide a framework for national legislation.
  • Taiwan enacted the Controlled Drugs Act in 1999 to enhance drug control.

Purpose of the Study:

  • To thoroughly discuss Taiwan's controlled drug management system.
  • To outline the key components of the Controlled Drugs Act.
  • To examine the scheduling and enforcement mechanisms for controlled drugs.

Main Methods:

  • Analysis of Taiwan's Controlled Drugs Act (1999).
  • Review of United Nations drug control treaties.
  • Description of the three-tiered management system: Schedule, Licensing, and Diversion Control.
Keywords:
controlled drugsdiversion controllicenseregulationschedule

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  • Examination of administrative sanctions for violations.

    • Main Results:

    • Controlled drugs are scheduled based on abuse potential and social hazard.
    • The management system integrates scheduling, licensing, and diversion controls.
    • Administrative sanctions are applied for violations of the Act.
    • Reporting and auditing systems are key components of diversion control.

    Conclusions:

    • Taiwan's Controlled Drugs Act provides a comprehensive framework for managing controlled substances.
    • The integrated management system aims to prevent diversion and abuse.
    • Effective enforcement and sanctions are vital for the success of the drug control policy.