KR Südkorea
  • 11 - Medizintechnik


Proposed amendments to the Regulations on Safety of Pharmaceuticals, etc.; (62 page(s), in Korean)

A. Expansion of recognition range of DMF submission (Article 15 of the draft, No 16 of form)

Data to be submitted on the manufacturing site of the drug substance for DMF are data complying with the drug substance GMP. This amendment is to accept data approved by the Minister of Food and Drug Safety as manufacturing certificate or the data corresponds to the certificate.

B. Establishment of regulations, such as procedures and methods for approval of the use of overseas investigational drugs for therapeutic purposes (Article 28-2 of the draft)

As the range of investigational drugs for approval of the use for therapeutic purposes has been expanded to include overseas investigational drugs, regulations such as application procedures and dossier were prepared.

C. Enactment of regulations for matters other than minor matters that does not require GMP determination of conformance to change (Article 48-3 of the draft)

As the subject of minor changes has been very limited and the subject of conformance to Change has been wide, significant changes that may affect the quality of pharmaceuticals were designated as matters other than minor and subject to conformance to change.

D. Preparation of regulations such as labeling and standards for medicines and quasi-drugs for the visually/hearing-impaired (Article 71-2, 75-2, and 75-3 of the draft)

As displaying braille and audio/sign language conversion codes on medicines and quasi-drugs prescribed by the Minister of Food and Drug Safety for the visually/hearing-impaired has been mandatory requirements, relevant indication methods and standards were established and regulation such as compliance on-site inspection and evaluation contents and methods were prepared.

E. Establishment of regulations such as methods and procedures for online monitoring of illegal medicine sales (Article 71-3 of the draft)

As the legal basis for entrusting online monitoring of illegal medicine sales has been established, regulations such as monitoring methods and procedures were prepared.