Pharmaceuticals

Proposed revision of the "Korean Pharmacopoeia"; (4 page(s), in Korean), (8 page(s), in Korean), (15 page(s), in Korean), (1484 page(s), in Korean), (357 page(s), in Korean), (362 page(s), in Korean), (265 page(s), in Korean)

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 and drug products for "Cefotiam Hexetil Hydrochloride Tablets" in Part 1 Monographs (Appendix 3 of the draft)

·        Additionof a new test method (Method2) utilizing state of the art analytical equipment for purity tests of "MumeFruit" and "Amomum Tsao-ko Fruit" to Part 2 of the Monographs (Appendix 4 of the draft)

·        Partial amendments to 6 specifications including preparation of Ninhydrin Sodium Bisulfite solution for identification of Hydroxypropyl Starch in part 2 of the Monographs (Appendix 4 of the draft)

·        Refinement of terminology in General Tests (Appendix 5 of the draft)

D. Addition of new test methods to General Tests (Appendix 5 of the draft)

·        Addition of two test methods (Delivered Dose Uniformity (DDU) and Aerodynamic Particle Size Distribution (APSD) testing for inhalers) for quality control of bronchial and pulmonary preparations

E. Addition of new test methods to General Information(Appendix 6 of the draft)

·        Addition of two test methods (nucleic acid-based method and rapid microbial detection method for advanced biopharmaceuticals) for R&D and quality assessment of advanced biopharmaceuticals including cell and gene therapy

·        Provision of Information for the management of microbial limit tests (application of water activity measurement test to non-sterile drugs) and quality control of additive ethanol (Alcoholometric Table)

·       Addition of two test methods (standardization method for crude drugs and genetic analysis method for herbal (crude) medicines) as reference for the quality control of herbal (crude) medicines