The Korean Society of Pharmaceutical Sciences (KSPS, President Jo Jung-won) announced on the 20th that it has been awarded a project commissioned by the Ministry of Food and Drug Safety (MFDS) and the National Institute of Food and Drug Safety Evaluation to develop guidelines for new technology and new concept drugs, specifically focusing on the equivalence of complex generic drugs.
This national project is valued at 2 billion KRW, with KSPS President Jo Jung-won (Professor at Chungnam National University College of Pharmacy) serving as the principal investigator, and 26 faculty members from the society participating.
Complex generics, due to their structural complexity and formulation specificity, have required scientific and regulatory standards beyond simple bioequivalence testing. In response, KSPS will deploy expert researchers in formulation design, drug delivery systems, and pharmacokinetics to establish an equivalence evaluation system tailored to complex generics.
Specifically, the project will develop customized equivalence evaluation and test method guidelines for 10 products across four formulation categories: oral, injectable, inhalation, and ophthalmic preparations. It will analyze the regulatory frameworks for complex generics from global agencies such as the U.S. FDA, the European Medicines Agency (EMA), and Japan's PMDA, and introduce evaluation standards suitable for the domestic pharmaceutical industry environment.
Additionally, based on industry demand surveys, the project will propose a new roadmap for development over the next three years, and will concurrently operate industry-academia-government consultative bodies, publish reference materials, and hold industry conferences to support implementation.
KSPS plans to use this complex generic guideline development project as a starting point to resolve regulatory uncertainties in the formulation R&D stage for domestic pharmaceutical companies, and to expand a long-term regulatory science network that supports the commercialization and overseas expansion of high-value-added drugs.
A KSPS official said, "Through this project, we plan to establish a scientific and predictable equivalence evaluation system for complex generics," adding, "We will collaborate with industry and regulatory agencies to diversify the global regulatory response network for domestic pharmaceutical and biotech companies."
Source: Read the original report | Published: May 20, 2026