Chinese SFDA issues new Regulation on a strengthened Supervision of Pharmaceutical Excipients' Manufacturers

The Chinese State Food and Drug Administration has published a regulation entitled "Regulation of Strengthening Supervision on Pharmaceutical Excipients" on 1 August 2012. This regulation has been prepared based on the "Drug Administration Law of People's Republic of China" and closes a further regulation gap concerning the manufacture of drug products after the publication of the regulations "Good Manufacturing Practice (GMP) for Drugs".

The regulation is subdivided into five chapters and contains provisions for:

  • drug product manufacturers who receive and use pharmaceutical excipients, 
  • manufacturers of pharmaceutical excipients, 
  • the inclusion of pharmaceutical excipients in the regulatory registration process, 
  • the strengthened regulatory supervision of the manufacture and the use of pharmaceutical excipients, 
  • the creation of an excipient-database.

This new regulation is largely consistent with the relevant IPEC Guidelines. For example, the supplier of excipients has to inform the drug products' manufacturer about changes critical to quality during excipient manufacture or testing. Furthermore, a quality agreement is mandatory between drug product manufacturer and excipient supplier. In order to enforce this regulation, the local authorities of the relevant provinces are required to intensify the supervision of excipient manufacturers by carrying out inspections more frequently and at irregular intervals.

IPEC China, sister organisation of IPEC Europe and IPEC America has translated the regulation-text into English. It was published on IPEC Americas' Website. The regulation will become effective as of 1 February 2013.

Please also see the "Regulation of Strengthening Supervision on Pharmaceutical Excipients". A summary of the regulation's key statements can be read on the Website of IPEC Americas.

Dr Gerhard Becker 
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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