“We reflected feedback from the field” ... MFDS to ease the burden of developing new and generic drugs

[Financial News] Regulations that required all medicines made for approval applications to be destroyed—and even generic drugs with well-established effects to undergo the same tests again—are being revised. The Ministry of Food and Drug Safety (MFDS) has unveiled plans to rationalize regulations in the bio sector, reflecting feedback from the field.

On the 23rd, the MFDS announced plans for global regulatory reform in the bio sector at the second plenary meeting of the Regulatory Reform Committee, held at the Blue House State Guest House under the theme “An Irreplaceable Korea: Opening the Path to Greater Growth Through Regulatory Reform.”

The MFDS has reformed its approval and review system, shortening the approval period to 240 days, and has also worked to establish a regulatory framework for digital medical products and help ease regulations on cosmetics exports. The latest measures aim to help K-bio achieve tangible growth in line with international standards. They comprise three pillars: global regulatory alignment that delivers tangible improvements on the ground; alignment of approval and review standards with global regulations; and the establishment of the world’s first regulatory support system for the bio sector.


First, medicines manufactured before approval will be allowed to be sold. Until now, only products made in accordance with their approved specifications could be sold after marketing authorization was granted, meaning that all medicines manufactured in advance for approval applications and other purposes had to be destroyed. Going forward, they may be sold if they meet requirements such as compliance with Good Manufacturing Practice (GMP) and manufacture in accordance with the final approved specifications, and have completed process validation. The aim is to expand patients’ treatment opportunities by getting medicines to market sooner.

Review guidelines will also be established for medicines developed using AI technology. There are currently no separate criteria for evaluating AI technology used in drug development, making it difficult for the industry to predict whether regulators would accept it. The plan is to set out specific criteria to reduce trial and error during product development and help save time and money in developing new drugs.

Review standards for generic drugs will also be tailored to the characteristics of each product. Currently, all generic drugs must submit bioequivalence study data when applying for approval. Going forward, drugs for which equivalence is clear, such as water-soluble injectable drugs, will be exempt from submitting supporting data, while ophthalmic ointments may use alternative tests that take product characteristics into account.

The review burden for over-the-counter drugs will also be reduced. Currently, they must submit the same level of review documentation as prescription drugs. Going forward, when a product has the same route of administration as one already approved or reported but a slightly different dosage form (such as ointment versus cream), the documentation required will be simplified in light of the mild pharmacological effects and side effects associated with such products. The aim is to encourage the development of a wider range of over-the-counter drugs and expand consumer choice.


A support framework for biopharmaceutical contract development and manufacturing (CDMO) exports will also be established. Under the Special Act on Regulatory Support for Companies Engaged in Contract Development and Manufacturing of Biopharmaceuticals, which takes effect on December 31, an export-specific regulatory framework will be created, covering the establishment of export manufacturing businesses, GMP certification and government certification of raw materials. The plan is to ensure the legal certainty of GMP certification and promote the domestic production of raw materials, helping local companies expand overseas.

Proactive support will also be provided for “digital combination medicines,” which combine medicines with digital technologies such as AI and software. Under the Digital Medical Products Act, product-specific joint response teams will be formed, and standard operating procedures for one-stop integrated reviews and guidelines for clinical trial design will be developed. The industry has faced difficulties developing these products because their classification, approval and licensing requirements, and quality control standards have not been clear.

The MFDS plans to continue engaging with those on the ground to create a regulatory environment aligned with international standards and to provide proactive regulatory support so that the country can establish itself as a leader in global regulation of emerging biotechnologies. 




[email protected] Jeong Myeong-jin, Medical Affairs Correspondent Reporter