Korea: Amendments to the Regulations on Safety of Pharmaceuticals

 

South Korea published new amendments to its Regulations on Safety of Pharmaceuticals, proposed by the Ministry of Food and Drug Safety (MFDS) in the Notification No. 2023-550 of 29 November 2023.

The amendments include:

1. Improvement of regulations related to submission for Marketing Authorization (revision of Article 4 of the regulation)

In the case of contracted manufacturing during the entire process, submission of evaluation data for GMP will be exempted, and in the case of national essential medicine for which there are no alternatives, some of the submission can be replaced with a letter of explanation when applying for authorization, allowing to implement rapid approval and minimize gaps in treatment for Korean patients.

1. Clarification of submission for approval of IND (revision of Article 24 of the regulation, Form No. 23)

When approving investigational new drug (IND) application, it was clearly stated so that the data necessary to be evaluated whether the investigational drug complies with GMP and GCP can be submitted.

1. Improvement of report on drug shortages (revision of Article 49 of the regulation, Appendix 8 II. No. 27)

The deadline for reporting on drug shortages will be set to 180 days in advance, and even in the case of shortages, it will be required to be reported so that the government can proactively respond to the shortages, the standards for administrative dispositions in case of non-reporting will be strengthened to increase the effectiveness of the report.

1. Improvement of procedures related to items in the patent list (revision of Article 62-4 and Article 62-11 of the regulation, new establishment of Form No. 59-8)

When changing matters listed in the patent list, minor matters that do not require a procedure to have public consultation from stakeholders will be regulated and documents and procedures to be submitted when reporting the occurrence of reasons for the expiration of prior marketing approval will prepared.

1. Modification of administrative dispositions related to safety management personnel (Revision of [Appendix 8] of the regulation, II. No. 23, 29)

In cases where a safety management manager is not appointed and when changes or cancellations are not reported, the disposal standard has been modified into suspension of marketing business.

1. Reorganization of forms related to determination of compliance with GMP (revision of forms No. 81, 81-2, and 82)

Forms on determination of compliance with GMP will be reorganized to include detailed dosage forms determined by the Minister of Food and Drug Safety.

The full text of the Notification can be accessed HERE.

To find out more pharmaceutical compliance, please contact the Product Compliance Institute directly.