Government to resume inspection of drugmakers’ overseas plants

The Ministry of Food and Drug Safety said Wednesday that it would resume the face-to-face field inspections of Korean pharmaceutical companies’ overseas manufacturing plants from April to November.

The Ministry of Food and Drug Safety will resume its on-site inspection of Korean drugmakers’ overseas manufacturing plants, suspended since February 2020 due to the Covid-19 pandemic.

The ministry has suspended its inspections since February 2020 due to the spread of the Covid-19 pandemic.

The ministry will conduct on-site inspections on 2,208 overseas manufacturing sites from April to November, beginning with 50 next month.

The drug authorities selected 30 out of the 50 sites in November and completed the assignment of due diligence schedules for each section. For the remaining 20 sites, officials will conduct an opinion inquiry after distribution by section in the risk assessment order.

The ministry evaluates risk levels by setting risk factor items, such as due diligence history, import performance, risk information, country of origin, and product characteristics based on the previous year of evaluation.

It plans to allocate a schedule for the 50 sites selected for this year’s on-site inspection within this month and confirm the final inspection date after reviewing the opinions of companies.

The ministry said it might add targets for its April on-site inspection if there is any new risk information that needs urgent confirmation or a company requesting cancellation of measures among companies that have failed to pass inspections in the past.

Drug officials will carry out on-site inspection by allocating five plants in two-month increments in the order of risk. If the on-site inspection is not possible due to natural disasters or infectious diseases two months before the final inspection date, the ministry will revert to the non-face-to-face method.

If on-site due diligence is difficult and the ministry has to carry out non-face-to-face due diligence, the ministry will recognize suitable companies for their due diligence equivalent to on-site due diligence, and companies that do not pass the inspection will be subject to measures such as cessation of imports.

Even in the case of suitable companies, the ministry may order them to submit additional data for companies that have shown insufficient data in its document review.

If the ministry determines that the additional data is insufficient, the agency can take measures such as import suspension.

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