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The new regulation on pharmaceutical gelatin excipients highlights five measures

The new regulation on pharmaceutical gelatin excipients highlights five measures

  • Categories:Industry News
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  • Time of issue:2015-04-17
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(Summary description)On August 2, the State Food and Drug Administration held a press conference to release "Relevant Rules for Strengthening the Supervision and Administration of Pharmaceutical Excipients." The "Rules" are clear and implement classified supervision on pharmaceutical excipients; pharmaceutical preparation manufacturers must conduct quality audits on pharmaceutical auxiliary manufacturers and establish supplier files. The "Rules" will be implemented from February 1, 2013.

The new regulation on pharmaceutical gelatin excipients highlights five measures

(Summary description)On August 2, the State Food and Drug Administration held a press conference to release "Relevant Rules for Strengthening the Supervision and Administration of Pharmaceutical Excipients." The "Rules" are clear and implement classified supervision on pharmaceutical excipients; pharmaceutical preparation manufacturers must conduct quality audits on pharmaceutical auxiliary manufacturers and establish supplier files. The "Rules" will be implemented from February 1, 2013.

  • Categories:Industry News
  • Author:
  • Origin:
  • Time of issue:2015-04-17
  • Views:0
Information

On August 2, the State Food and Drug Administration held a press conference to release "Relevant Rules for Strengthening the Supervision and Administration of Pharmaceutical Excipients." The "Rules" are clear and implement classified supervision on pharmaceutical excipients; pharmaceutical preparation manufacturers must conduct quality audits on pharmaceutical auxiliary manufacturers and establish supplier files. The "Rules" will be implemented from February 1, 2013.

Pharmaceutical excipients indicate the excipients and additives used in the production of medicines and the distribution of prescriptions, which can directly affect the quality and safety of medicines. The chromium hyperbranched medicinal capsules are caused by the fact that local medicinal capsule manufacturers use industrial gelatin to pretend to use medicinal gelatin to produce capsules, and use unqualified 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 demonstrate the differentiation of regulatory ideas and methods: First, it is clear that enterprises producing pharmaceutical excipients must enforce the "Quality Management Standards for Pharmaceutical Excipients" "If there are serious quality problems, cancel the product license. It is reported that the "Regulations for the Administration of the Quality of Pharmaceutical Excipients" was introduced in 2006, but due to the large number of manufacturers, the variety of products, and the weak government supervision, it has long been used by companies for reference. The second is to implore the food and drug regulatory section to implement the classification of medicinal excipients, that is, to implement the new medicinal excipients and medicinal excipients with high safety risks and agree to handle them, and implement the filing of other excipients. The third is that the State Food and Drug Administration will arrange for the National Pharmacopoeia Commission to develop and revise the quality specifications of pharmaceutical excipients, and release the national specifications for pharmaceutical excipients; translate some local 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 section can conduct extended inspections on the pharmaceutical auxiliary manufacturers based on the problems found in the supervision and inspection of the pharmaceutical preparation manufacturers. Fifth, it is imploring that the food and drug supervision section establish a database of medicinal accessories and a credit file of the enterprise producing medicinal materials.

 

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