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Regulators tell 68 firms to revalidate inflammation therapies’ efficacy
  • By Lee Hye-seon
  • Published 2017.08.24 18:13
  • Updated 2017.08.24 18:13
  • comments 0

Sixty-eight inflammatory diseases therapies that failed to prove effectiveness in medicine reexamination last year will have to conduct additional clinical trials.

The Ministry of Food and Drug Safety (MFDS)식약처 Wednesday announced clinical reexamination of medications containing streptokinase and streptodornase, which failed to validate their effectiveness in the last reevaluation.

The medicines that contain streptokinase and streptodornase have indications to mitigate symptoms after surgery and injury, sinusitis symptom, inflammatory edema, and expectoration difficulty accompanied by respiratory diseases.

Major products include Varidase by SK Chemical SK케미칼, Mucolase by Hanmi Pharm 한미약품, Leodase by Shin Poong Pharm신풍제약, and Ahntorase by Ahngook Pharm안국약품.

The companies that market these products have to submit clinical trial plans to the ministry’s medicine safety evaluation division by Oct. 20.

Those who don’t have intents to conduct clinical trials have to hand in statements of the reason they should be exempted.

If the companies don’t submit plans by the deadline, the ministry imposes administrative disciplines on them, so they have to inform the ministry of whether or not they will conduct clinical trials.

Also, companies that conduct clinical trials have to report the progress on a regular basis to the ministry. If the firms don’t submit reexamination applications and the results of clinical trials on time, they will also be subject to disciplinary actions.

Previously, drugs that contain isopropylantipyrine (IPA), such as painkillers Saridon and Geworin, conducted clinical trials and revalidated their effectiveness, and medicines that have titrated extract of Zea Mays L. Unsaponifiable Fraction, such as a gum therapy Insadol, have increased their efficacy through the reexamination of clinical trials.

lhs@docdocdoc.co.kr

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