"Medicines Made Before Approval Can Also Be Sold"... MFDS Overhauls Biopharma Regulations

Review Guidelines to Be Established for Medicines Developed Using AI
Review Standards for Generic and Over-the-Counter Medicines to Be Rationalized

Going forward, medicines manufactured before obtaining marketing authorization are expected to be eligible for sale, rather than having to be discarded, if they meet certain requirements. New review standards will be established for medicines developed using artificial intelligence (AI), while the review burden for generic and over-the-counter medicines will also be reduced.

The Ministry of Food and Drug Safety building in Cheongju, North Chungcheong Province. The Asia Business Daily database.

Oh Yu-kyung, Minister of Food and Drug Safety, announced the “Plan to Rationalize Regulations in the Bio Sector to Match Those of Competing Countries” at the second plenary meeting of the Regulatory Rationalization Committee, held on October 23 at the Cheong Wa Dae guesthouse in Jongno-gu, Seoul. The plan aims to support the growth of the K-bio industry in line with international standards. It comprises six tasks across three areas: aligning regulations with global standards in ways that make a tangible difference on the ground; aligning authorization and review standards with global regulations; and establishing a regulatory support system for the bio sector.

First, the Ministry of Food and Drug Safety will allow the conditional sale of medicines manufactured before authorization. Until now, all medicines made before authorization had to be discarded. 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 authorization details.

The ministry also plans to develop separate review guidelines for medicines developed using AI technology. Concerns have been raised that companies find it difficult to predict review outcomes because there are currently no separate evaluation standards.

Review standards for generic and over-the-counter medicines will also be rationalized. Until now, all generic medicines have had to submit data from bioequivalence studies. Going forward, submission of such data will be waived when equivalence is clear, as with water-soluble injections, while ophthalmic ointments may use alternative tests suited to their product characteristics. For over-the-counter medicines, the required submission materials will be simplified when the route of administration remains the same and only the dosage form changes, such as changing an ointment to a cream.

A system will also be established to support exports by contract development and manufacturing organizations (CDMOs) for biopharmaceuticals. Under the Special Act on Regulatory Support for Contract Development and Manufacturing Organizations for Biopharmaceuticals, which takes effect on December 31, an export manufacturing business category will be established, and systems for GMP certification and government certification of raw materials will be introduced. For digital convergence medicines that combine AI or software with pharmaceuticals, the ministry will form product-specific joint response teams and establish a one-stop integrated review system and guidelines for clinical trial design.

“We will continue to engage with stakeholders on the ground, create a regulatory environment aligned with international standards, and provide proactive regulatory support so that we can lead global regulation in emerging bio technologies,” a ministry official said.

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