Chinese Journal of Pharmacovigilance ›› 2012, Vol. 9 ›› Issue (7): 418-420.

• Orginal Article • Previous Articles     Next Articles

Analysis and Reflection on Technological Examination for License Renew Application of Drugs

LIU Jin-xia   

  1. Centre for Drug Evaluation and Certification of Henan, Henan Zhengzhou 450000, China
  • Received:2011-12-30 Online:2012-07-10 Published:2015-08-07

Abstract: ObjectiveTo improve the examining process of license renew application for supervision and management of drugs. MethodsThe main points of technological examination for drug license renew application were summarized and analyzed, including the range of production permit, quality standards, adverse reactions and so on. Resultsand ConclusionThe improvement of quality of evaluation and policy and regulations play an important role in license renew application.

Key words: drug license renew application, technical examination, analysis and reflection