The Ministry of Food and Drug Safety (MFDS) said it will resume on-site inspections of overseas biopharmaceutical manufacturing plants, currently suspended due to the Covid-19 pandemic, starting from 2023.

The MFDS revised the “Pre-Good Manufacturing Practice (GMP) Evaluation of Biopharmaceuticals” regulation on March 29, 2021 due to the prolonged Corona 19 situation and converted the due diligence process to a non-face-to-face system for overseas manufacturing sites.

When inspecting biomanufacturing sites, the MFDS looks into whether the manufacturing and quality control standards for biopharmaceuticals that have applied for permission or manufacturing or sales of imported drugs with changed permission meet the ministry’s criteria.

However, with the recent easing of Covid-19 rules, the MFDS said on-site due diligence at overseas manufacturing sites will be possible from next year.

As the MFDS is conducting on-site inspections for the first time in over two years, it will first conduct due diligence on overseas sites manufacturing new drugs that have never received the ministry's inspection.

The ministry plans to add inspection sites for any new risk information that needs urgent confirmation or plants that have failed to pass inspections in the past.

The regulator will dispatch two or three GMP inspectors for on-site inspections overseas.

However, the MFDS will to continue providing remote inspections for plants that manufacture orphan drugs or treatments subject to expedited review, it said.