Inspections target faulty packaging·labeling of drugs

and illegal advertising of obesity drugs

The Korean gov't-local gov't to launch planned joint inspection of medicinal products for Q2

Inspections will target illegal advertising of GLP-1 obesity drugs, such as Wegovy, by medical clinics·pharmacies

The Korean government and local governments will launch inspections targeting pharmaceutical companies with a history of recalls due to faulty packaging or labeling of medicinal products and illegal advertising of GLP-1 obesity drugs, such as Wegovy.

 

For GLP-1 obesity drugs, to prevent misuse and abuse, inspections will focus on handling medical clinics and pharmacies to check for direct-to-consumer advertising of specialized medicines and whether information exceeding the scope of approved indications is being exaggerated or falsely advertised to the general public.

 

Following the inspections, pharmaceutical companies, medical institutions, pharmacies, and wholesalers found to violate these terms will face measures such as administrative guidance or administrative penalties.

 

On June 23, the Ministry of Food and Drug Safety (MFDS) announced that it would conduct planned joint inspection with local MFDS agencies and local governments to strengthen the safety management of medicinal products· biopharmaceutical products·Korean traditional medicines·quasi-drugs·medical devices.

 

This second-quarter joint inspection of medical products will run until June 27.

 

For medicinal products, manufacturers with a history of recalls due to packaging·labeling defects will be inspected, given the continuous occurrence of such recalls.

 

Key inspection points include, ▲Whether the company has implemented follow-up measures and recurrence prevention plans submitted during previous drug recalls ▲Whether follow-up measures from self-inspections related to packaging·abeling processes have been carried out.

 

If follow-up measures are not implemented or violations are confirmed during the inspection, necessary actions, including administrative penalties, will be taken.

 

During the summer, concerns about misuse and abuse are rising due to illegal advertising of specialized medicines, including online posts featuring post-treatment reviews that describe GLP-1 obesity biopharmaceuticals as 'weight loss drugs' or promotional materials placed in patient waiting areas.

 

To prevent the misuse and abuse of obesity treatments, MFDS will focus on handling medical clinics and pharmacies to inspect ▲Whether prescription drugs are being advertised to the general public through various advertising media ▲Whether exaggerated·false information exceeding the scope of approved indications is being released to an unspecified public.

 

If violations are confirmed during the inspection, necessary actions such as administrative guidance or administrative penalties will be taken against the medical clinics, pharmacies, and, if necessary, wholesalers or pharmaceutical manufacturers.

 

For Korean traditional medicines (Hanyak), rigorous quality control is required for high-value herbal ingredients, such as 'Nokyong' and 'Uhwang'.

 

Therefore, manufacturers of these herbal ingredients and manufacturers of hanyak ingredients containing 'Uhwang,' such as 'Uhwangcheongsimwon,' will be inspected.

 

Key inspection points will include ▲Appropriateness of quality control for raw materials and finished products ▲Appropriateness of raw material storage management and finished product manufacturing management.

 

For quasi-drugs, to ensure a safe distribution environment for anti-snoring products used to reduce or suppress snoring noise, manufacturing (importing) companies will be inspected for ▲Performance of quality inspections for raw materials and finished products ▲Microbiological quality control ▲Appropriateness of hygiene management of manufacturing facilities.

 

Additionally, inspections for false·exaggerated advertising will be conducted on sanitary product vendors frequently found with identical advertising violations on numerous online sales sites.

 

If violations are confirmed in advertisements provided by manufacturing (importing) companies, those manufacturers (importers) will also be inspected.

 

As instances of unapproved illegal medical devices being imported through direct overseas purchases or purchasing agencies continue to occur, companies frequently caught importing illegal medical devices at the import·customs clearance stage will be inspected.

 

Key inspection points will include ▲Whether illegally imported medical devices are being illegally distributed ▲Whether return or disposal measures have been taken ▲Other violations of the Medical Devices Act.

 

If inspections confirm violations, such as storing or distributing illegally imported medical devices without returning or disposing of them, necessary actions, including administrative penalties, will be taken.

 

Meanwhile, to enhance the effectiveness of this planned joint inspection, the MFDS conducted pre-training on inspection methods for the '2025 Q2 Medical Products Sector Inspection Officer Training' (6.19.~20.), involving local MFDS agencies and local governments (cities·provinces, cities·counties·provinces).