Australian-first manufacturing and hands on training facility to produce medical products for early stage human clinical trials receives funding from MTPConnect’s Project Fund Program
PharmOut is proud to partner with these prestigious Australian organisations and …
On October 31, the ODC released an online smart form as well as “flat” paper forms to apply for a cultivation, production or research medicinal cannabis licence. This online form can also be used …
Today the TGA just released a new medicinal cannabis GMP compliance guide titled “Guidance on GMP compliance for the manufacture of medicinal cannabis for supply under ‘approved access’ provisions”.
Not sure there would be any experienced …
Previously we wrote about the TGA planning to revise the complementary medicine guidelines. On the 13 October 2016 the Australian TGA released the sixth version of the Australian regulatory guidelines for complementary medicines ARGCM, Version 6.0, October …
The recent scheduling changes to medicinal cannabis, which includes cannabidiol (abbreviated as “CBD”) and tetrahydrocannabinols (“THC”), moving it from Schedule 9 (prohibited substance) to Schedule 8 (controlled substance). This change, coupled with the rapidly …
In October 2013, the Therapeutic Goods Administration (TGA) announced the launch of the Medical Device Single Audit Program (MDSAP) pilot from January 2014, together with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, …
Purpose
This White Paper on how to “How to list or register a medicine in Australia” is written to assist those interested in the process for approval to supply TGA regulated therapeutic products in Australia.
Audience
This White …
This White Paper offer practical advice on “How to list or register a complementary medicine in Australia”, complementary medicines include vitamin, mineral, herbal, aromatherapy and homeopathic products. Products that may be considered to be …
Purpose
This white paper on “how to register a prescription medicine in Australia” provides an outline of the legal and regulatory requirements and processes for obtaining approval to supply prescription medicines in Australia. It outlines …
eCTD submissions
PharmOut dialed in to listen to the eCTD Introductory Meeting on July the 3rd, which was hosted by the TGA in Canberra and was run by John Bell, eCTD Project Manager, TGA and …
