1. Reasons for Amendment

This amendment aims to proactively support the Regulations, including the definition of new concept products such as microbiome-based medicines and the establishment of new nucleic acid medicines review standards, add injectable drugs that patients can self-administer to the drugs subject to submitting the risk management plan, 

provide standards for submission data preparation and review so that the Quality by Design (QbD) can be applied when product approval for biologics, etc., improve the conditions for submitting test results when testing the quality of vaccines to minimize animal testing, and improve the requirements for submitting stability test data when changing a manufacturing method.

2. Major Provisions

A. New definition, etc., of microbiome-based medicines (live biotherapeutic products) (Article 2)

B. Provide quality review requirements for the application of the QbD system (Articles 4 and 26)

C. Expand the scope of the “Science Citation Index” recognized as pharmacological action and clinical trial results data (Article 7)

D. Improve the requirements for submitting stability test data when changing a manufacturing method (Article 7, Attached Table 1)

E. Stipulate the subjects, etc., to submit the “Risk Management Plan (RMP) Overview” (Articles 7-2 and 9)

F. Strengthen the safe use of “self-administered injections,” such as adding subjects to submit the risk management plan (Articles 7-2 and 17, Attached Table 9-3)

G. Present additional information to be set forth on permitted matters (properties, precautions for use, etc.) for drugs and for the safe use of drugs (Articles 13 and 18)

H. The “animal test” result data of vaccine products can be replaced with the final crude solution test result data. (Article 26)

I. Provide review standards for nucleic acid vaccines (RNA or DNA vaccines) (Article 28)

J. Specify examples of preparing manufacturing methods for recombinant medicines and cell culture medicines (Attached Table 5)