The Korea Food and Drug Administration (KFDA), which has been criticized for a drug registration process that is often not transparent, recently announced efforts to make the process simpler and more comprehensible.
According to KFDA officials, the agency has prepared detailed manuals on Korean drug registration standards. There are four such manuals, divided into safety, efficacy, product standards, and testing methods. The pharmaceutical industry will be able to refer to these manuals to better understand the drug registration application process and prepare drug registration dossiers on a more routine basis.
The KFDA plans to publish more manuals in the future. These manuals are likely to cover general topics, such as clinical trial data, and specific topics, such as drugs for hypertension.
The agency also plans to introduce a new Common Technical Dossier (CTD) standard in the near future.
These moves are one part of a campaign by the KFDA Commissioner, Mr. Yun Yeo Pyo. Mr. Yun hopes to improve the agency’s image in its regulation of drugs, medical devices, and food, under the broad slogan, “peace of mind for the public, vitality for industry.” Other ongoing projects include increased training and improvement of standards and testing methods. The KFDA’s public image deteriorated in 2008 after melamine was found in Chinese foods on the Korean market.