GMP Clearance Guidance

TGA Clearance applications for overseas manufacturers are now required to be submitted along with a GMP Agreement detailing arrangements between the sponsor and manufacturer. The TGA has indicated that in addition to the normal scope of GMP Agreements, specific areas [...]

2020-04-23T10:20:39+00:00September 7th, 2018|Complementary Medicines, Listed Medicines, Regulation, TGA|

eBS Permitted Indications

Effective March 8th 2018 Permitted indications are now available through eBS for listed medicines. The TGA has implemented a list of permitted indications for medicines listed under Section 26A of the Therapeutic Goods Act 1989 (the Act). The list of [...]

2020-04-23T10:20:39+00:00March 13th, 2018|Complementary Medicines, Listed Medicines, Regulation, TGA|

TGA eBS Outage

The Therapeutic Goods Amendment Bill No.1. of 2017 received royal ascent on Monday 5th March, as such the proposed reforms have now begun to be implemented. As of midday yesterday (6th March 2018), the TGA have temporarily closed the application [...]

Changes to the Uniform Recall Procedure for Therapeutic Goods

The Uniform Recall Procedure for Therapeutic Goods (URPTG) is a guidance document, which provides a standardised systematic procedure, to assist sponsors to conduct both recall and non-recall actions of therapeutic goods which are supplied, imported into or exported from Australia. [...]

Consultation: Business Process Improvements Supporting Complementary Medicines Assessment Pathways

The TGA is seeking comments from interested parties on a range of reforms to the regulatory framework for complementary medicines, to address Government-agreed recommendations arising from the Review of Medicines and Medical Devices Regulation. The consultation discusses: A risk-based approach [...]

Updated Permissible Ingredients Determination

An updated version of the Therapeutic Goods (Permissible Ingredients) Determination was registered on the Federal Register of Legislation (FRL) in September 2017. The updated determination is titled the Therapeutic Goods (Permissible Ingredients) Determination No. 4 of 2017. A total of [...]

2020-04-23T10:20:40+00:00October 13th, 2017|Complementary Medicines, Listed Medicines, Regulation, TGA|

Pharmacovigilance Update

On 1st September 2017, the TGA published the revised edition (Version 2.0) of the ‘Pharmacovigilance responsibilities of medicine sponsors - Australian recommendations and requirements’.  This guidance sets out the pharmacovigilance responsibilities of sponsors of medicines included on the Australian Register [...]

2017-09-28T05:34:46+00:00September 26th, 2017|Complementary Medicines, Listed Medicines, Regulation, TGA|

Listed Medicine Reforms – Permitted Indications and Application Fees

Permitted Indications The closing date for proposing additional indications or evidence qualifiers to the TGA to be considered for the core list of permitted indications, is 31 October 2017. After this date, the list will be finalised and if sponsors [...]

2020-04-23T10:20:40+00:00September 26th, 2017|Complementary Medicines, Listed Medicines, Regulation, TGA|

Third Assessment Pathway for Listed Complementary Medicines

Intermediate Level – Listed Assessed Medicines Reform recommendations for complementary medicines has seen the development of a three-tiered, risk-based framework for the regulation of CAM's. The revised framework introduces a new (intermediate risk) assessment pathway sitting between the existing listed [...]

2020-04-23T10:20:40+00:00September 26th, 2017|Complementary Medicines, Listed Medicines, Regulation, TGA|

Low THC Hemp Seeds Permitted as Foods

12 November 2017 will see the variation to Standard 1.4.4 – Prohibited and restricted plants and fungi to permit the sale of foods derived from the seeds of low THC varieties of C. sativa come into effect. Maximum levels of [...]

2020-04-23T10:20:40+00:00September 26th, 2017|Foods, FSANZ, Regulation|