New Regulations on Supervision of Pharmaceutical Gelatin Excipients Highlight Five Measures

On August 2, the State Food and Drug Administration held a press conference to issue the relevant rules on strengthening the supervision and handling of pharmaceutical excipients. The Rules are clear and subject to classified supervision of pharmaceutical excipients; pharmaceutical preparation manufacturers must conduct quality audits of pharmaceutical excipients and establish supplier files. The rules will be implemented from February 1, 2013.

On August 2, the State Food and Drug Administration held a press conference to issue the relevant rules on strengthening the supervision and handling of pharmaceutical excipients. The Rules are clear and subject to classified supervision of pharmaceutical excipients; pharmaceutical preparation manufacturers must conduct quality audits of pharmaceutical excipients and establish supplier files. The rules will be implemented from February 1, 2013.

Pharmaceutical excipients are the excipients and additives used in the production of drugs and the distribution of prescriptions, which can directly affect the quality and safety of drugs. Chromium overspending medicinal capsules is caused by local medicinal capsule production enterprises using industrial gelatin to fake medicinal gelatin to produce capsules and using substandard capsules to produce inferior drugs.

Zhang Wei, Director of the Drug Registration Department of the State Food and Drug Administration, introduced that there are five measures in the Rules that show the innovation of regulatory ideas and methods: First, it is clear that enterprises producing pharmaceutical excipients must enforce the "Regulations on Quality Handling of Pharmaceutical Excipients". If there are serious quality problems, the product consent certificate will be revoked. It is reported that the "Regulations for the Production and Quality of Pharmaceutical Excipients" was issued in 2006, but due to the large number of production enterprises, many types of products, and weak government supervision, it has long been only used for reference by enterprises. The second is to implore the food and drug regulatory department to classify and handle pharmaceutical excipients, that is, to promise to handle new pharmaceutical excipients and pharmaceutical excipients with higher safety risks, and to file other excipients. Third, the State Food and Drug Administration will arrange the State Pharmacopoeia Commission to carry out the task of revising the quality standards for pharmaceutical excipients and issue the national standards for pharmaceutical excipients. Translate local foreign specifications for pharmaceutical excipients as referral specifications. It is estimated that by 2015, the pharmacopoeia will contain 300 types of pharmaceutical excipients. Fourth, the food and drug supervision part can extend the inspection of pharmaceutical excipients production enterprises according to the problems found in the supervision and inspection of pharmaceutical preparation production enterprises. Five is to implore the food and drug regulatory part to establish pharmaceutical excipients database and pharmaceutical excipients production enterprise credit files.