Australia – TGA Brings 6 Guidance Documents in Line With PIC/S Guide to GMP

TGA has updated six guidance documents to bring them into line with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP guide, PE 009-13. Most of the documents relate to the quality and production of complementary medicines.

The Australian regulator published the original versions of the five complementary medicine texts in 2009 and 2010. TGA only made small changes to the documents in the following years. That changed this week, when TGA published version 2.0 of each document. In each case, TGA has changed the title and scope of the document while ensuring it is consistent with the PIC/S guide to GMPs.

The current version of the guide, which was released at the start of 2017, features annexes on the production of herbal medicines — also known as complementary medicines — and medicinal gases, the topics covered in the documents TGA updated this week. The annexes set out how the unique features of herbal medicines and medicinal gases affect approaches to GMP compliance…