MFDS to maintain small-packaging drug regulations

Exceptions allowed upon submission of product-specific explanations and supporting materials

Industry request rejected…MFDS requests pharmaceutical companies to self-adjust voluntarily

The Ministry of Food and Drug Safety has recommended that pharmaceutical companies voluntarily adjust their own packaging practices rather than granting the industry’s request to relax small-packaging regulations due to stable drug supply concerns arising from the Middle East conflict. The move is interpreted as maintaining the small-packaging regulations while expanding recognition of exceptional cases. Industry requests for a grace period on administrative penalties this year appear to have been rejected following opposition from pharmacy organizations and related groups.

This is interpreted as the government’s intention to expand the recognition of exceptions while maintaining compliance with the small-packaging regulations. It is analyzed that the industry’s initial request for a suspension of administrative penalties this year was rejected due to opposition from groups such as the Korean Pharmaceutical Association.

According to industry sources on the 18th, the MFDS recently sent an official notice to pharmaceutical associations requesting that each pharmaceutical company voluntarily adjust small-package supply ratios.

Under the current “Regulations on Supply of Pharmaceuticals in Small Packaging Units,” pharmaceutical manufacturers and importers are required to supply at least 10% of their annual production or import volume to pharmacies in small packaging units.

The standards are set at 30 tablets or fewer for bottle packaging, 100 tablets or fewer for blister packs, and 500 mL or less for syrups. Violations result in administrative penalties such as suspension of sales operations.

The mandatory small-packaging rule was originally introduced to reduce excessive inventory at pharmacies and the resulting social costs from the disposal of unused stock.

Recently, the pharmaceutical industry requested relaxation of the small-packaging regulations due to shortages of pharmaceutical packaging materials caused by instability in naphtha supply stemming from the Middle East conflict. In particular, the industry requested suspension of administrative penalties this year, even if mandatory small-package production ratios were not met.

On the 2nd of last month, MFDS Minister Yu-Kyoung Oh visited JW Pharmaceutical to inspect IV solution packaging and announced that the ministry would swiftly pursue proactive administrative measures, including the relaxation of the small-packaging obligations.

Following this, the MFDS working-level department reviewed the potential easing of the small-packaging requirement. However, pharmacy organizations, including the Korean Pharmaceutical Association, opposed such measures, citing concerns such as inventory disposal, making policy decisions difficult.

Ultimately, it appears the MFDS has decided to adhere to the regulations while actively utilizing exceptions.

In an official notice, the MFDS stated, “The MFDS has recommended that pharmaceutical companies voluntarily reduce the use of drug packaging materials, such as by adjusting the ratio of small-volume packaging.”

The ministry added, “While complying with the minimum standards for small-package supply in consideration of the purpose and intent of the ‘Regulations on Supply of Pharmaceuticals in Small Packaging Units,’ if compliance becomes difficult due to shortages in packaging material raw supplies caused by wartime conditions, companies may submit statements on product-specific explanations and supporting materials to the MFDS under Article 5 of the regulation to receive exemption from the small-package requirements.”

The measure is ultimately interpreted as maintaining the small-package supply obligation while broadly recognizing exception products.

A pharmaceutical industry official stated, “In response to opposition from the Korean Pharmaceutical Association and others, it appears that the request for a suspension of administrative penalties requested by the industry has not been accepted. However, the MFDS’s request for voluntary adjustment by pharmaceutical companies can be interpreted as an intention to actively recognize exceptions.”