إجراء مقترح من كوريا الجنوبية

A. Allowing notification of address changes due to administrative district reorganization (Article 8, 24, 35, 37) Where an address change results from administrative district reorganization, the procedures are simplified as follows: - for pharmaceutical manufacturers, importers and contract manufacturing and sales business operators, the change may be notified instead of obtaining approval - for approved clinical trial protocols, the change may be notified instead of obtaining approval - for clinical sample analysis institutions and non-clinical testing institutions, the change may be notified instead of applying for a change in designation B. Adjusting the deadline for submitting recall plans for marketed pharmaceuticals(Article 50) If pharmaceuticals being marketed in Korea have safety and efficacy issues, the deadline for submitting a recall plan is adjusted. C. Prohibiting AI-generated advertisements falsely implying endorsement or recommendation by medical professionals AI-generated advertisements that may mislead consumers into believing that medical professionals endorse or recommend medical products are prohibited.'(Article 78 and Annex 7) D. Revising GMP for investigational products (Annex 4-2) Good Manufacturing Practice for investigational products is revised to align with international standards E. Reducing the processing period of Investigational New Drug Applications (Change)(Annexed Form No. 23) If an IND application is found to be compliant in the pre-review…