What is the CPAC in South Korea?

The Central Pharmaceutical Affairs Council (CPAC) plays a vital role in ensuring the safety and efficacy of drugs marketed in South Korea. Established under the Pharmaceutical Affairs Act (PAA), this high-level government advisory body functions as the gatekeeper for new medications entering the market.

The Drug Approval Process

The CPAC’s core function lies in reviewing and approving new drugs for sale in South Korea. This rigorous process involves meticulous evaluation of scientific evidence, based on factors such as:

• Safety: Minimizing potential risks and side effects for patients.
• Efficacy: Confirming the drug’s efficacy in treating the targeted condition.
• Quality: Ensuring that the drug is manufactured consistently, according to the established standards.

Through a meticulous examination of these aspects and by allowing only safe and effective medications into the South Korean market, the CPAC safeguards public health.

Sub-committees for Focused Regulation

The CPAC is further divided into specialized sub-committees, which enables it to delve deeper into specific areas of pharmaceutical regulations. These sub-committees provide focused guidance and advice to the council on topics relevant to their expertise, such as:

• Drug Safety
• Clinical Trials
• Drug Pricing
• Pharmacovigilance (Drug Safety Monitoring)

The above sub-committees act as crucial extensions of the CPAC, facilitating a comprehensive and nuanced approach to pharmaceutical quality control in South Korea.

Thus, the CPAC serves as a cornerstone of the South Korean pharmaceutical Regulatory landscape. Through its expert-driven composition, rigorous drug approval process, and specialized sub-committees, the CPAC fosters public trust by ensuring the safety and efficacy of medications available to South Korean citizens. Do you want to know more about the CPAC? Get in touch with our experts today!