The Korean Pharmaceutical and Bio Association and the Korea Food and Drug Administration have launched a "GMP Regulation Harmonization Consultation Hotline" to support domestic pharmaceutical and bio companies in complying with global manufacturing and quality management standards (GMP). This initiative serves as a public-private partnership to quickly identify and address challenges arising from changes in global GMP standards.
On July 20, the Korean Pharmaceutical and Bio Association announced the establishment and full operation of the GMP Regulation Harmonization Consultation Hotline.
Domestic companies have faced difficulties in preparing documentation due to varying requirements from regulatory agencies in different countries. The GMP regulation harmonization consultation aims to swiftly identify industry inquiries and challenges arising from changes in global GMP standards and to develop practical responses.
Pharmaceutical and bio companies can submit inquiries and suggestions related to the GMP compliance process through the consultation channel on the Korean Pharmaceutical and Bio Association's website. Submitted issues will be reviewed by experts, and matters requiring technical review and support will be discussed in collaboration with the "Global GMP Implementation Technical Support Council," which includes representatives from the Korea Food and Drug Administration, the association, and industry experts.
The association plans to enhance accessibility for the industry by revamping the consultation channel on its website and actively promoting the GMP regulation harmonization consultation hotline. This initiative aims to systematically gather feedback from the field regarding changes in global GMP regulations and to strengthen communication between the industry and regulatory agencies.
The GMP regulation harmonization consultation was established as part of the "Global GMP Implementation Technical Support Council," formed in March to assist the industry in complying with global GMP standards.
The council operates in three subcommittees focusing on the application of PUPSIT (Pre-Use Post-Sterilization Integrity Testing), freeze-drying barrier technology, and current GMP issues, with industry experts participating to discuss stable implementation and practical application of global GMP standards.
An association official stated, "To respond to changes in the global GMP regulatory environment, continuous communication and field-oriented technical support between regulatory agencies and the industry are essential. Through the GMP regulation harmonization consultation, we will actively support the establishment of manufacturing and quality systems that meet global standards by gathering diverse opinions from the industry."
The GMP regulation harmonization consultation can be accessed through the "GMP Regulation Harmonization Consultation (Hotline)" menu on the Korean Pharmaceutical and Bio Association's website.
* This article has been translated by AI.
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