In late June, the Australian Federal Government released the Stage 1 report on the Review of Medicines and Medical Devices Regulations. In the first of two articles on the Expert report Robert Stringer of CapitalK consulting takes a look at the recommendations for the future of medicines regulation in Australia. One things’s for sure… the TGA’s here to stay, but nonetheless there are far reaching changes proposed for prescription medicines regulation.
Archives for July 2015
The Commonwealth Health Department has formed a new Regulatory Services Division – bringing together TGA with agricultural chemicals, veterinary medicines and gene technology regulation. Within TGA there’s a wholesale reorganisation back to the more traditional product groupings. TGA national Manager John Skerritt takes on leadership of the whole lot
Brandwood Biomedical is 15 years old! When we started the European Directives were just settling in, GHTF had yet to publish a document, and the Japan PAL was still five years into the future. It’s been a fascinating journey.
Thanks to all of our many clients who have shared our journey – we have been honoured by the trust you have placed in us.
As regulators around the world are all engaged in substantial reforms – bringing in new and raising the bar for compliance, it’s not surprising it can all seem a bit overwhelming and intimidating. The solution is perhaps simpler than it seems – conversation.
Faced with a backlog of submissions, the Malaysian Medical Device Authority has extended the transition period for medical device registrations to July 2016. Manufacturers have until July 2016 to file a registration submission and will be allowed to import and market devices and IVDs beyond that date pending determination of the submission review. Read on to download the official announcements and registration guidances.
TGA will replace the cumbersome and ineffective Low Value Turn Over (LVT) scheme with a new set of Fee exemptions for products without commercial sales
All new entries on the ARTG are automatically qualified for ACE exemption subject to a sponsor declaration made at the end of the first year confirming if there were in fact no sales. TGA also signalled introducing fee waivers for devices which do not achieve commercial viability but which for public health reasons needs to remain on the register.