Western drug companies are demanding improvements to Korea’s “Innovative Company” criteria. Up until now, the Korean government has been choosing innovative firms every two years. Since the program started, there have been 49 designated innovative drug companies, but only 4 of these were foreign drug companies. If a drug company meets the Innovative criteria, it will become eligible for tax breaks and preferred treatment. One of the main criteria is a large R&D budget compared to the company’s revenue. Foreign drug companies say that transparency in choosing the innovative companies is lacking, that R&D expenditures should be based on global R&D collaborations (not just investments in Korea), and they demand feedback on why their company and drug do not qualify for being innovative. The Korean government is hearing these strong concerns, but whether the evaluation process becomes more objective and transparent is not clear.
The Food and Drug Administration of the Philippines (FDA Philippines) has issued a policy change allowing Market Authorization Holders (MAHs) to submit multiple post-approval changes (PACs) for a registered pharmaceutical product in one application. This aligns with the agency’s new policy direction to make its regulatory strategies and actions less burdensome. The agency is allowing MAHs to submit multiple PACs as either Major Variations (MaVs) or Minor Variations – Post Approval (MiV-PAs) through the Integrated Application Form (IAF). However, the IAF can only accommodate at most three PAC submissions. This revision excludes Minor Variation – Notification (MiV-N) filings, which will need to comply with existing procedures. Government fees are still charged on a per-change basis, regardless of whether changes are bundled into one application or submitted separately.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.