1887

oa SA Pharmaceutical Journal - Medicine registration numbers : industry in-site

 

Abstract

The thalidomide tragedy in the early 1960s prompted authorities to introduce an evaluation system globally whereby the safety, efficacy and quality of any new medicine had to be assessed and approved before the medicine, including complementary medicines, was marketed. Prior to this, there was no formal system of medicine registration and any new preparation could be introduced onto the market without the manufacturer having carried out preclinical and clinical testing, and without having had the manufacturing materials and procedures regulated and approved.

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/content/mp_sapj/78/2/EJC82531
2011-03-01
2016-12-04
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