The Central Pharmaceutical Affairs Council (CPAC) is a high-level government advisory organization formed under the Pharmaceutical Affairs Act in South Korea. The council is made up of up to twenty-five (25) members, all of whom are specialists in pharmaceutical science, medicine, law, and the pharmaceutical industry.
The CPAC is in charge of a wide range of functions connected to pharmaceutical control in South Korea. Its principal role is to assess and approve new drugs for sale in the country based on scientific evidence of their safety, efficacy, and quality. The council also monitors the safety and efficacy of existing pharmaceuticals on the market, and it has the right to take Regulatory action if there are concerns about the safety or quality of a product.
In addition to Regulatory responsibilities, the CPAC is crucial in influencing National Pharmaceutical Policy. The council provides pharmaceutical advice to the Ministry of Food and Drug Safety (MFDS), covering drug pricing, reimbursement regulations, and drug supply chain management. It also seeks to enhance R&D in the South Korean pharmaceutical industry by sponsoring universities and business research activities.
The CPAC is divided into subcommittees that focus on various aspects of pharmaceutical regulation and policy. These include drug safety, clinical trials, drug pricing, and pharmacovigilance committees. These subcommittees advise and guide the council on topics related to their respective areas of competence.
Overall, the CPAC is an important player in South Korean pharmaceutical regulation. Its involvement in reviewing and approving new products, monitoring the safety and efficacy of existing treatments, and setting national pharmaceutical policy serves to guarantee that South Koreans have access to safe, effective, and inexpensive medicines.
It is crucial to comply with the regulations and policies set forth by the CPAC to ensure the safety and efficacy of your products. With our team of experts, we can help you navigate the complex landscape of pharmaceutical regulations in South Korea. Contact Freyr to learn more.