Australian Government proposed to bypass TGA for medical devices with CE Marking...

Under the Leadership of Prime Minister Tony Abbott Australian Government has proposed to allow domestic medical device manufacturers to register their routine products in the country using CE Marking certificates from European Notified Bodies.

This proposal which is part of new government  position paper pushing innovation with competitiveness issue in essence to remove TGA Certification requirements for Australian medical devices that have received CE Marking from European Authorities.

TGA allow import of medical devices with CE Marking from foreign manufacturers, even domestic manufacturers that have received CE Marking for their products still have to register with TGA for marketing authorization to market in Australia.

For more information view/download the Position Paper on Industry Innovation and Competitiveness of Australian Government.

to register their “routine” products in the country using CE Marking certificates from European Notified Bodies - See more at: http://www.raps.org/Regulatory-Focus/News/2014/10/22/20608/Australian-Government-Proposes-Bypassing-TGA-for-Medical-Devices-with-CE-Marking/#sthash.tjxSuOxM.dpuf

to register their “routine” products in the country using CE Marking certificates from European Notified Bodies. - See more at: http://www.emergogroup.com/blog/2014/10/australian-government-proposes-bypassing-tga-medical-devices-ce-marking#sthash.ESZxrSZx.dpuf

TGA : Launched a new online service to make it easier for consumers to report side effects from medicines

The Therapeutic Goods Administration (TGA) has launched a new online service to make it easier for consumers to report side effects from medicines and vaccines.

The TGA said adverse events were under-reported around the world with 90 to 95 per cent estimated to go unreported to regulators.

"There is an international trend for regulators to encourage reporting by consumers and the release of the new consumer-focused web reporting option forms part of the TGA's effort," the TGA said.

ach year, the TGA receives more than 17,000 reports of suspected adverse events to medicines and vaccines.

In 2013, about 3 per cent of these reports came from consumers, compared with 55 per cent coming via pharmaceutical companies, 17 per cent from State and Territory Health Departments, 10 per cent from hospitals and hospital pharmacists and the remainder from community pharmacists and general practitioners.

"The new web-based reporting service for consumers is one of a range of initiatives being implemented by the TGA to encourage reporting among this group," the TGA said.

Other activities include a brochure outlining to the public what and how to report side effects, awareness activities and consumer research to help plan further projects to raise awareness.

The new online service can be found at this PS News link and the brochure here.

TGA Guidance for Orphan Drug Application...

Guidance on orphan drug designation has been published as part of an ongoing initiative to provide our stakeholders with a clear understanding of Australia's regulatory requirements for therapeutic goods.

This was progressed as part of the TGA reforms: A Blueprint for TGA's future.

The Blueprint aims to improve the Australian community's understanding of our regulatory processes and decisions, and to enhance public trust in the safety and quality of therapeutic goods. As part of this, we are working to ensure that the regulatory guidance available to potential applicants is accessible, comprehensive, easily understood, and available in different formats to meet their needs.

'Orphan drugs' are often developed to treat small and very specific patient populations who suffer from rare diseases and conditions.

The application and evaluation fees for orphan drugs can be waived to:

• help reduce their development costs
• facilitate their access to the Australian marketplace

However, a medicine needs to be:

• designated by us as an orphan drug before an application can be accepted to register it on the Australian Register of Therapeutic Goods (ARTG)
• evaluated for quality, safety and efficacy in the same way as other registered medicines.

GUIDELINES AVAILABLE CLICK HERE

TGA: Clarified Drug Approval Process in a New Document

Australia’s Therapeutic Goods Administration (TGA) this week issued a new question and answer (Q&A) guidance concerning the registration process for new prescription drugs, as well as how to make changes to an already registered product that involves clinical, nonclinical or bioequivalence data. 

The guidance, released on 3 September 2014, covers a wide range of questions, including one on the use of Section 31 (s.31) questions during the application process.

The consolidated s.31 is a single request for information, which brings together in one document all the questions that have been raised concerning the application from all of the relevant review units of the TGA. If a sponsor needs clarification as to any question in the s.31 document, a written request must be submitted to the TGA.

TGA: Updated Australian regulatory guidelines for complementary medicines (ARGCM)...

The Australian regulatory guidelines for complementary medicines (ARGCM) provide information for manufacturers, sponsors, healthcare professionals and the general public on the regulation of complementary medicines in Australia.

If you want to supply a complementary medicine in Australia, you may choose to employ a regulatory affairs consultant (for a list of consultants, refer to the Complementary Medicines Australia, the Australian Self Medication Industry and the Association of Therapeutic Goods Consultants).

Print Version of the Australian regulatory guidelines for complementary medicines (ARGCM) can be downloaded CLICK HERE.