News

NEWS CENTER
Your present position:
Home >
Laws & Regulations

NMPA Issued the Announcement on the Cessation of Production, Sale and Use of Furazolidone-Containing




On February 15, 2019, NMPA issued the Announcement on the Cessation of Production, Sale and Use of Furazolidone-Containing Compound Preparations, which reads as follows: As per Article 42 of the Drug Administration Law of the People's Republic of China and Article 40 of the Regulations for Implementation of the Drug Administration Law of the People's Republic of China, and NMPA re-evaluation, furazolidone-containing compound preparations are deemed as prone to serious adverse reactions, the risk of use outweighs its benefit in China. NMPA hereby decides to stop with immediate effect the production, sales and use of such preparations in China, and revoke the corresponding drug NMPA released on March 12, 2019 the Announcement on Revising the Package Inserts of GuCi (Bone Spur) Capsules and Tablets, with decision made to revise the Entries of [Warnings], [Adverse reactions], [Contraindications] and [Precautions] of the package inserts of GuCi (Bone Spur) Capsules and Tablets. (March 12, 2019) prescription drugs to non-prescription drugs. The list of specific varieties and the Template of non-prescription drug package inserts are released at the same time. (February 19, 2019) approval proof documents. The marketed furazolidone-containing preparations shall be recalled by the manufacturer responsible, the recall should be completed prior to March 31, 2019, and the recalled products shall be destructed under the supervision of the competent food and drug administration department.

 (February 15, 2019)