Drugs manufactured before receiving product approval will be allowed to go on sale after approval if they meet certain requirements. Separate review standards will be set for medicines developed using artificial intelligence, and the approval and review burden for generic and over-the-counter drugs is expected to ease.
The Ministry of Food and Drug Safety announced the biotechnology measures, titled a plan to bring regulation in line with competitor countries, at the second meeting of the Regulatory Rationalization Committee held at the Blue House guest house on the 23rd. The package has six main tasks: drafting review guidelines for drugs developed with AI, expanding permission to sell drugs manufactured before approval, improving review standards for generic drugs, simplifying review documents for over-the-counter drugs, building an export support system for biopharmaceutical contract development and manufacturing organizations, and introducing integrated review for digital convergence drugs.
The biggest change is allowing sales of drugs manufactured before approval. Under current rules, medicines produced in advance for purposes such as filing a product approval application cannot be sold even after final approval is granted, and the entire batch must be discarded. Going forward, output produced before approval can be sold if it meets requirements including compliance with good manufacturing practice (GMP) standards, manufacturing identical to the final approved terms and completion of process validation. The ministry also plans to set detailed sales requirements and management measures.
Once the system takes effect, drugmakers will face a lighter cost burden from having to discard pre-approval output. The process of producing products again after approval will also be reduced, which is expected to bring forward market launch dates. The ministry said the change will speed up drug supply and improve patients' access to treatment.
Separate review standards will also be prepared for new drug development using AI. Until now, there have been no clear criteria for evaluating the technology and data involved even when AI was used in the development process, such as in discovering candidate substances or predicting toxicity. The ministry plans to draw up review guidelines for AI-assisted drugs to improve regulatory predictability for companies.
Review procedures for generic and over-the-counter drugs will also be revised. Generics with clear equivalence, such as water-soluble injections, will be exempt from submitting equivalence data, while products such as ophthalmic ointments will be able to substitute alternative testing that reflects product characteristics. For over-the-counter drugs with the same route of administration but minor differences in formulation — such as tablets versus capsules, or ointments versus creams — submission requirements will be simplified in consideration of pharmacological action and the risk of side effects.
The ministry will also build an export support system for biopharmaceutical CDMOs. Under a special act on regulatory support for contract development and manufacturing companies in the biopharmaceutical sector, which takes effect on Dec. 31, the ministry will create an export manufacturing business category and introduce government-level GMP certification and a raw material certification system. The step is designed to help domestic CDMOs and raw material producers deal with regulations as they enter overseas markets.
For digital convergence drugs, which combine medicines with AI and software, the ministry will form joint response teams for each product and build a one-stop integrated review system. It also plans to prepare clinical trial design guidelines to flesh out approval and review standards for digital convergence drugs, which remain at an early stage.
"We plan to continue communicating with the field to create a regulatory environment that meets international standards, and to do our best to provide pre-emptive regulatory support so that the country can establish itself as a leader in global regulation of new biotechnologies," a ministry official said.