MFDS: "Temperature Must Be Recorded When Transporting Biological Products... Introduction of GMP for Quasi-Drugs"

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[Asia Economy Reporter Seo So-jeong] From now on, when transporting pharmaceuticals that require refrigerated or frozen storage, such as biological products, automatic temperature recording devices must be equipped and the temperature must be recorded.

The Ministry of Food and Drug Safety (Commissioner Kim Gang-rip) revised and promulgated the "Regulations on the Safety of Pharmaceuticals, etc." on the 20th, which mainly strengthens the safety and management standards for pharmaceutical distribution and improves the operation standards of the pharmaceutical approval and review system.

According to the revision, holders of pharmaceutical product approvals, importers, and pharmaceutical wholesalers must equip automatic temperature recording devices when transporting pharmaceuticals requiring refrigerated or frozen storage (including biological products) and include temperature in the transportation records of pharmaceuticals.

Administrative sanctions standards have also been established for holders of pharmaceutical product approvals and importers who violate this. For the first violation, the sales operation of the relevant product will be suspended for 3 months; for the second violation, suspended for 6 months; and for the third violation, the approval will be revoked.

Additionally, the procedure is improved so that pharmaceutical suppliers who report pharmaceutical supply details electronically do not need to separately record and store pharmaceutical inbound and outbound records.

Starting January 1 next year, the education obligation for pharmaceutical wholesalers will be expanded from current qualified wholesalers under the Korea Good Supply Practice (KGSP) to all wholesalers, and pharmaceutical wholesalers will be able to request the Korea Pharmaceutical Distribution Association to conduct the in-house training that must be provided to their employees.

The operation standards for the pharmaceutical approval and review system will also be improved. When applying for approval of finished pharmaceuticals, data submitted during the prior registration of raw materials will be exempted from submission, but data other than those submitted during raw material registration must be submitted.

Pharmaceuticals subject to priority review are specified as "drugs for severe and rare diseases for which there are no alternative drugs or drugs with significantly improved safety and efficacy," and will be reviewed within 90 days unless there are special circumstances.

Furthermore, manufacturing and quality control standards (GMP) will be introduced (recommended) in the quasi-drug sector, and a ‘Certificate of Conformity’ will be issued when these standards are complied with.

In addition, after the approval of finished pharmaceuticals, the approval review results will be disclosed within 180 days from the approval date after hearing the opinion of the approval holder.

The Ministry of Food and Drug Safety stated, "This revision is expected to enhance the safety and management level of pharmaceutical distribution and to help operate the pharmaceutical approval and review system rationally and transparently," and added, "We plan to actively improve the pharmaceutical safety management system based on scientific knowledge and regulatory expertise."

This content was produced with the assistance of AI translation services.