The Ministry of Food and Drug Safety (MFDS)식품의약품안전처 has made it clear it would push ahead with obligating domestic pharmaceutical companies to indicate all substances of drugs starting on Dec. 3.

The ministry’s reaffirmation of its adamant stance came in the form of a reply to the industry’s request for self-reliant implementation of some of the rules.

It examined the opinions of Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA)한국바이오제약협회 on the “revision on the indications of medicines and other products” put on public notice in June, and sent its position to the association.

According to the reply, the ministry did not accept the industry’s request that they are allowed to indicate the instructions and validity period of drugs at places they like.

The pharmaceutical industry asked for self-reliant indications of instructions and validity terms, saying it 's hard to add these things because there are many things to write on the labels of medicinal products. However, the ministry stuck to its position emphasizing the need to standardize the places of indication.

“The instructions and expiration date are valuable information customers and experts need, but many people have raised the issue saying they can hardly find them,” said an official at the ministry’s Medicine Management Division.

Nor did the ministry accept the industry’s demand to allow companies to change writing orders, saying they have to write indications according to the standard form

“It 's hard to accept the industry’s request because the orders of standard items were based on how to provide information in unified ways and help consumers find them quickly,” the official said.

The mandatory indication of all drug substances is a follow-up measure to strengthen the safety of medications since the issue of the harms of preservative and other substances have been raised continuously.

Accordingly, the ministry obligates the companies to indicate all material names, quantity of effective compounds, preservatives, and tar color written in item permission certificate and item report certificate in cases and packages of medicines and quasi-medicinal products

The ministry will apply the new rule to all drugs manufactured and imported after Dec. 3, while giving a one-year grace period to those produced and imported before the date.

It also will delay the implementation of the rule until Jan. 1, 2019 for solid content drugs in packaging units of 10 or more tablets or capsules, additives, and cataplasmas.