1. Reason for revision
It is intended to accept Appendix Specifications in Standard manufacturing practice for medicines, to add new types and new mixing ratios, to activate manufacture of general medicines by increasing daily maximum dose, and to expand optional width of general medicines for consumers. It is also intended to strengthen safe control of medicines with reflection of safety information by such method as restriction of administration of cold medicines for 2-year or younger children in general medicines.
2. Main content
A. Raw materials of Appendix Specifications of the standard and testing methods evaluated through prior review, etc. may be used as the items of standard manufacturing practice (Article 4-2 and Article 4-3 of Appendix Table 1 of draft).
B. Establishment of reviewing procedure and related opinion submission methods, etc. for adequacy of “Standard manufacturing practice for medicines” (Article 5 of draft).
C. Administration of cold medicines for 2-year or younger children in general medicines is restricted, information on adverse events of pseudoephedrine is reflected in precautions, and the age for administration of complex medicines containing kaolin and complex medicines containing hydrotalcite is limited to adults and 15-year or older persons, respectively.
(Chapter 2, Chapter 3, Chapter 4, Chapter 7, and Chapter 9 of Appendix Table 1 of draft)
D. Permissions of ingredients, types, contents, efficacy, and effects, etc. are separately prescribed in Table 7 with addition of single agents having administration and daily maximum doses within Table 1 among domestically permitted vitamin and mineral products (Chapter 1 of Appendix Table 1 of draft).
E. The ranges of granule agents and capsule agents are embodied and new type oral jelly agents, oral dissolution tablets, and oral dissolution films are added (Chapter 1 of Appendix Table 1 of draft).
F. It is prescribed that period of use (validity) shall follow “Regulations on report and review of item permission of medicines” and it is clearly prescribed that, if the period of use (validity) of permission/report items cannot be followed, the period accepted through review of safety review or publicly acceptable clear evidential data shall be submitted.
(Chapter 1 of Appendix Table 1 of draft)
G. Mixing ingredients of taurine, mecobalamin, and cobamamide, of which the safety and efficacy was proved based on domestically permitted (reported) medicines or foreign standard manufacturing practice for general medicines, are added, maximum daily dose of some mixing ingredients such as chondroitin sulfate sodium, etc. is increased, and information on adverse events of tauline and chondroitin sulfate sodium is added. (Chapter 1 of Appendix Table 1 of draft)
