'Standard' Labeling Requirement Removed from Pharmaceutical Packaging... "Supporting Prompt Supply"

MFDS Announces Draft Amendment to Pharmaceutical Affairs Act Enforcement Decree
Reduces Burden of Packaging Replacement
Establishes Procedures for Requesting Expanded Production of Essential Medicines

The obligation to indicate the "standard" of active ingredients on pharmaceutical containers and packaging will be eliminated. This revision aims to ease the burden on the pharmaceutical industry, which previously had to discard all existing packaging and produce new materials every time ingredient standards were changed, thereby ensuring a more stable supply of medicines.

On April 13, the Ministry of Food and Drug Safety announced a draft amendment to the "Pharmaceutical Affairs Act Enforcement Decree" and the "Regulations on the Safety of Pharmaceuticals, etc." and stated that public comments would be accepted until June 10.

The amendment first relaxes the labeling requirements for pharmaceuticals. Until now, pharmaceutical companies were required to indicate the type and amount of active ingredients, as well as the "standard," on containers, packaging, or accompanying documents for pharmaceuticals.

However, whenever the standard of the active ingredient changed, labeling materials such as containers and packaging had to be replaced, resulting in additional replacement costs and, in some cases, temporary interruptions in the supply of medicines. Accordingly, the Ministry of Food and Drug Safety will relax the obligation to indicate the standard, in order to prevent unnecessary waste of resources and support the prompt supply of medicines. Detailed standards will be continuously available through the Ministry's "Drug Safety Information Portal."

Regulations concerning changes in manufacturing scale for registered active pharmaceutical ingredients will also be rationalized. Previously, an application for change registration was required if the manufacturing scale changed by "10 times or more," but this requirement will now apply only when the change exceeds "10 times."

In addition, in line with the revision of the Pharmaceutical Affairs Act scheduled to take effect in November next year, the Ministry will prepare operational plans reflecting the expanded composition and functions of the "National Essential Medicines Stable Supply Council." The Ministry has also specified detailed procedures for the Minister to request pharmaceutical manufacturers and importers to expand production or importation, as delegated by law, to ensure a stable supply of medicines.

The Ministry of Food and Drug Safety stated, "Through this revision, we expect to reduce the industry's burden from unreasonable regulations and establish a foundation for the timely and safe supply of essential medicines to the public."

Further details on the amendment can be found on the Ministry of Food and Drug Safety website.

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