إجراء مقترح من كوريا الجنوبية

The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea intends to revise the following provisions of the Korean Pharmacopoeia: To respond to changes in the international regulatory environment, the Korean Pharmacopoeia (KP) will be completely revised from the 12th to the 13th edition. This revision aims to ensure the distribution of quality-assured pharmaceuticals and secure competitive edge in global markets by reorganizing KP and harmonizing pharmaceutical standards and specifications internationally. A. Revisions based on international harmonization of Pharmacopoeia Discussion Group (PDG) (Appendix 1, 5 and 6 of the draft) Replacement of 'Korean Pharmacopoeia 12th edition' with 'Korean Pharmacopoeia 13th edition' in Article 1.1 of General Notices (Appendix 1 of the draft); Harmonization of two methods (mass variation test for uniformity of dosage units and disintegration test for suppositories and vaginal tablets) with PDG standards (Appendix 5 of the draft); Reflection of the latest revisions to the PDG guidelines for international harmonization (Appendix 6 of the draft) B. Revision of General Notices and General Requirements for Pharmaceutical Preparations of the Korean Pharmacopoeia (Appendix 1 and 2 of the draft) C. Corrections of errors and reorganization of test methods and terminology in Monographs and General Tests (Appendix 3, 4 and 5 of the draft) Partial amendments to 28 specifications including application of a common assay to drug substances…