The TGA has issued a Guidance for Sponsors and stakeholders regarding the management and reporting and communication of medicine shortages and discontinuations in Australia. From January 1 2019 all medicine sponsors are required to report to the TGA medicine shortages and discontinuation as publication is now mandatory. Some definitions as per TGA website: “A medicine […]
The TGO 101 requirements commence on 31 March 2021 enabling a 2-year transition period. “This guidance is to help sponsors and manufacturers of medicines understand the role of the Therapeutic Goods Order No. 101 – Standard for tablets, capsules and pills (TGO 101, the Order) in ensuring that these types of therapeutic goods are of […]
May 2019 – TGA notifies of fees and charges for 2019-20 (becoming effective from 1 July 2019); 1 July to 22 July 2019 – Period for sponsors to submit their declarations of $0 turnover for any relevant ARTG entries; 1 August 2019 – Annual charge invoices for all non-exempt ARTG entries will be issued; 15 […]
We are so proud to have received an award from ARCS and voted as “Favourite CRO, Consultancy or Partner – Biotech Regulatory Solutions Pty Ltd”. Thank you to our clients and peers for your support. It has been a great 10 years working together to enable medicines (innovative, generic and biosmilars) and other therapeutic goods […]
Biotech Regulatory Solutions chaired a session at the ARCS Sydney Annual Conference 2017 “A Case Study Using Novel Scientific Technologies to Mitigate Risk in Drug Development” with Speaker Daina Vanags PhD. “…With the advancement of technologies such as induced pluripotent stem cells (iPSCs) regulators are highlighting concepts such as “Clinical trials in a dish” whereby […]
The TGA has released two consultation guidance documents to industry on the soon-to-be implemented Pharmacovigilance(PV) Inspection programme applicable to the Australian therapeutic industry. The TGA are conducting workshop sessions in 3 major cities TGA Pharmacovigilance Inspection Program: Information Sessions. Please contact Biotech Regulatory Solutions to discuss your companies needs and readiness for TGA PV Inspections. We […]
Biotech Regulatory Solutions has a team of highly experienced and leading therapeutics industry professionals covering Regulatory Affairs, Quality Assurance, Pharmacovigilance, Promotional Material review, and Medical Information services. Our consultants are based in Sydney, Brisbane, Melbourne and Singapore. Our team are all leading professionals in the therapeutics industry with experience ranging from 15 years to over […]
TGA has approved Australia’s 1st monoclonal antibody biosimilar INFLECTRA infliximab (rmc) 100mg Powder for Injection vial, a biosimilar medicine. On the ARTG 19th August 2015.
Biotech Regulatory Solutions chaired a session at ARCS Annual Scientific Conference in Sydney May 2015 on Extrapolation of Indications for Biosimiliars Key note speaker from the Therapeutic Goods Administration (TGA).
Biotech Regulatory Solutions presented and chaired at a session at ARCS Annual Scientific Conference in Sydney May 2015 on Literature Based Submissions (LBS the Options and the Lessons) Key note speaker from the Therapeutic Goods Administration (TGA)