Wu Ming-Mei, an official of the TFDA, said in an interview that the TFDA has carried out an analysis on drug manufacturing processes and organized an expert meeting to establish the standard content of NDMA in drugs, in the light of the NDMA detected in some hypertension drugs and gastric drugs. From 2021, APIs and drugs shall all comply with the standard content of NDMA.
The authorities in the EU and the US have confirmed that traces of NDMA were found in ranitidine used as an API in some gastric drugs. In response to this report, the TFDA ordered that all products in concern should be taken off the shelf as a precautionary measure until they pass the inspection and are proved to be safe.
Dr Chen Shih-Chung, the Minister of the MOHW, said on the 25th in the Legislative Yuan that, as of the 25th, 12 batches of products have passed the inspection and can be back on the market again.
Legislator Chiang Wan-an (KMT) asked the Minister whether the MOHW has any measures for ensuring drug safety as, in this incident, NDMA were produced during manufacturing processes. The MOHW Minister replied that the TFDA has identified 34 manufacturing processes which could cause the appearance of NDMA and will test each process and draw conclusions.
Wu Ming-Mei expressed that since the detection of NDMA in some hypertension drugs last year, the TFDA has formulated a 3-stage measure for controlling the impurities of NDMA. Firstly, the testing for Sartan in drugs for controlling blood pressure will be included in the Chinese Pharmacopeia by the end of this year. Next year, the TFDA will roll out a program to communicate the risk of manufacturing processes with the manufacturers of drugs containing high risk ingredients in addition to Sartan. And finally, from 2021, all APIs and pharmaceutical preparations shall comply with the international standard for NDMA, i.e. under 0.03PPM.
【2019-09-25/ RTI】
