(1) Reasons for Proposal
This Partial Amendment aims to harmonize drug authorization standards with international ones by ensuring reliability by strengthening in-process control in prescription drugs and maintaining quality equivalence in generic drugs, indicating the name of the active ingredient in the name of a prescription drug with complex ingredients, abolishing obligations to submit manufacture and sales certificates for imported novel drugs, and deleting some documentation exemption based on a foreign drug information reference when granting authorization.
(2) Major Provisions
A. Prepare the basis to connect drug products and drug substances for review (Article 3).
B. Strengthen post-marketing change management including in-process control for prescription drugs (Articles 3-2, 5, and 14, and attached Table 15).
C. For drugs which apply design space, whose connection with drug quality guarantee has been proven, to manufacture and quality control, prepare the basis to list design space in the applicable part of the authorization (reporting) application form (Article 4).
D. Abolish obligations to submit manufacture and sales certificates for imported novel drugs (Article 4).
E. Prepare the basis to submit clinical/non-clinical basic data in the CDISC standard format (Article 6).
F. Prepare the basis to provide the WHO Anatomical Therapeutic Chemical Code in marketing authorization and reporting (Article 9).
G. Indicate the name of the active ingredient in the name of a prescription drug with complex ingredients (Article 10).
H. Define the packing unit of a single-use eye drop as ≤ 0.5 ml and newly insert cautions to be labeled (Articles 17 and 18).
I. Delete a provision which allows the use of a foreign drug information reference as evidence in an effort to strengthen the safety and efficacy review system based on scientific evidence (Articles 25 and 28, and attached Table 1).
J. Newly insert the scope of locally applied preparations for external use subject to the drug equivalence test and the range of documentation to be submitted (Articles 25 and 27).
K. Prepare the basis that skips some items in release test and sets some items as a periodic or short-form test if data for production methods and development data for test methods, including in-process control documentation, are acceptable when preparing criteria or test methods (Article 31).
L. Newly insert a system that allows for contacting applicant handling staff in person or consulting with the staff in teleconference after filing for novel drug marketing authorization (Article 55-4).
