Related Experiment Video
Updated: May 13, 2026
06:49
Visualizing the Gatekeeper: Evan's Blue Dye-Based Assessment of Blood-Brain Barrier Permeability in Adult Zebrafish
Published on: September 30, 2025
Access to regulatory information in Malaysia - a preliminary study
1National Poison Centre, Universiti Sains Malaysia, 11800 Penang, Malaysia.
The International Journal of Risk & Safety in Medicine
|March 21, 2013
Summary
Malaysia
Area of Science:
- Pharmaceutical regulation
- Drug safety and efficacy
- Health policy in Malaysia
Background:
- Malaysia enacted The Control of Drugs and Cosmetics Regulations in 1984.
- A decade later, significant improvements in drug quality, safety, and efficacy were observed.
- Access to regulatory information remained under-examined.
Purpose of the Study:
- To conduct a preliminary survey on access to regulatory information in Malaysia.
- To examine the drug registration process post-1984 regulations.
Main Methods:
- Preliminary survey on information access.
- Examination of the drug registration process.
- Analysis of regulatory control in Malaysia.
Main Results:
- The study highlights a considerable improvement in the overall drug situation in Malaysia.
- It identifies a gap in attention towards access to regulatory information.
- The drug registration process under the 1984 regulations is examined.
Conclusions:
- While drug quality has improved, access to regulatory information requires further attention.
- The 1984 regulations have positively impacted the drug landscape.
- Further research is needed to address information accessibility challenges.
Related Concept Videos
01:25Drug Regulation
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...
01:19Pharmacovigilance
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.
In some cases, there...
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.
In some cases, there...
01:28Global Regulatory Systems
Global regulatory systems in bacteria enable rapid and coordinated responses to environmental changes by integrating sensory inputs with gene expression, ensuring efficient adaptation to fluctuating conditions. Key global regulatory mechanisms include regulons, two-component systems, sigma factors, and secondary messengers.Regulons and Global RegulatorsA regulon is a collection of genes and operons controlled by a common global regulator. These regulators enable bacteria to prioritize resource...
01:03Drug Control Governance: Regulatory Bodies and Their Impact
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 a...
01:16Clinical Trials
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
01:28Preclinical Development: Overview
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...