Pharmaceuticals

Draft amendment of the "Regulation on Safety of Pharmaceuticals, etc." (17 page(s), in Korean)

1) Establishment of Criteria for Administrative disposition for where false approval is obtained (Proposal [Attachment 8])

 - A new set of detailed criteria for administrative disposition for where permission or approval is obtained by a false or other wrongful method (e.g., revocation of approval).

2) Reinforcement of criteria for administrative disposition for where pharmaceutical manufacturing, test instructions and records are falsely prepared (Proposal [Attachment 8])

 - Reinforcement of criteria for administrative disposition for where pharmaceutical manufacturing, test instructions and records are not prepared or falsely prepared.

3) Establishment of criteria for administrative disposition for where national lot release is falsely permitted (Proposal [Attachment 8]).

 - Establishment of criteria for administrative disposition for where national lot release is obtained by a false or other wrongful method (e.g., revocation of approval for the item)

4) Changes to the effective date and transitional measures for "enhancement on obligation of pharmaceutical manufacturers" (Article 4 and 48 of Proposal)

 - Notification in advance of re-legislation to shorten the effective date and transitional measures deadline for the pharmaceutical manufacturing and application of GMP including disinfectants for medical devices, which was notified in advance on 18 November 2019.

5) Improvement of time frame for reporting changes in the registration of Active Pharmaceutical Ingredient (API) (Article 17 of Proposal) 

 - Improvement of time frame for reporting changes in the registration of Active Pharmaceutical Ingredient (API) from the existing deadline "by 31 January every year" to "by the end of the month that belongs to the date of registration every year".

6) Creation of the basis for exemption of analysis and testing for the person who imports national essential drugs (Article 60 of Proposal);

 - The basis allows to substitute the analysis and testing for the importer with testing report from original manufacturer even where the minister of Ministry of Food and Drug Safety recognizes that there will be likely to fail to treat the patients due to the absence of alternative pharmaceuticals when national essential drug supply is suspended.

7) Subdivisions of criteria for administrative disposition for where the manufacturing and testing contract acceptor violates commission/entrustment regulation (Proposal [Attachment 8])

 - Distinguishment on the scope of contract acceptor's commission/entrustment and the criteria for the administrative disposition for violations of supervision responsibilities so that they can be applied to herbal medicines without classification of dosage forms.

8) Reduction of criteria for administrative disposition for where minor changes in pharmaceutical approval and notification are not submitted (Proposal [Attachment 8]

 - Reduction of criteria for administrative disposition for where the changes in pharmaceutical approval and notification are not submitted aside from where approval for product change is not obtained.

9) Subdivision of criteria for administrative disposition for where some of the Pharmaceutical Risk Management Plan (RMP) have not been implemented (Proposal [Attachment 8]). 

- If a safety management is not implemented according to the Pharmaceutical Risk Management Plan (RMP), the criteria for the disposition is subdivided, except for unmet number of target, and the criteria for the administrative disposition for where some of them are not implemented are reduced.