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Regulators discipline 2 firms for insufficient data submission
  • By Lee Hye-seon
  • Published 2017.06.01 15:53
  • Updated 2017.06.01 15:53
  • comments 0

The Ministry of Food and Drug Safety (MFDS) said Wednesday it had disciplined two pharmaceutical companies for failing to submit data needed for reexamining their products’ safety and efficacy. It partially suspended the sales business of MSD Korea and slapped fines on S.biomedics.

Ministry of Food and Drug Safety

MSD Korea한국MSD failed to submit part of the data needed to reexamine 100μg and 150μ infertility therapy Elonva Inj. (compound: Corifollitropin alfa), and the ministry ordered it to stop selling the drug for three months, from June 12 to September 11 for three months.

S.biomedics에스바이오메딕스 didn’t hand in the documents for reexamining its acne scar therapy Cure-Skin Injection. The ministry first put it on a six-month sales suspension of the product but reduced it to a fine of 4.5 million won ($4,000).

Medicines are on a watch list after winning approvals, to confirm their safety and efficacy. The reexamination is one of post management measures, a system designed to collect information and reevaluate them for securing safety and effectiveness of new drugs and ensuring their proper use.

According to rules concerning the safety of medical and other products, the ministry can suspend the selling of medicines for three months to companies that fail to submit documents for the reevaluation of new drugs once; stop selling for six months for firms which do not hand in data twice. And if they still don’t provide the application form or all documents in three months after the end of reexamination period, the ministry also imposes sales suspension for six months for first-time violators and cancels approvals for second-time rule breakers.

lhs@docdocdoc.co.kr

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