Australia’s TGA Confirms ArteriumTM Medicines Production Meets International GMP Standards
The evaluation covered sterile production, specifically the ampoule and infusion lines at Halychpharm, the manufacturing site producing Arterium TM medicines. As part of the procedure, the Therapeutic Goods Administration (TGA) of Australia officially recognized the manufacturing site as compliant with Good Manufacturing Practice (GMP) standards adopted in Australia.
“Recognition of GMP compliance by the Australian regulator TGA is a strategic achievement that confirms the high quality of our manufacturing processes and opens new business opportunities for Arterium. In the long term, this will help accelerate entry into adjacent markets, particularly Singapore, New Zealand, and Malaysia. All products manufactured on the GMP-compliant production lines may subsequently be considered for registration in Australia and other Southeastern Asian countries via simplified procedures,” said Dmytro Vovkohon, International Market Development Manager of the Strategic Marketing Service.
TGA (Therapeutic Goods Administration) is a division of the Australian Department of Health and one of the strictest pharmaceutical regulators in the world. The agency ensures that only effective, high-quality, and safe medicinal products are allowed on the market.
It is important to note that Australia and the European Union have a valid Mutual Recognition Agreement (MRA) in the field of GMP. This means that the regulatory authorities of both parties exchange information and recognize each other’s inspections results, which further underscores the significance of obtaining GMP clearance from TGA.
“Australia is one of the most promising pharmaceutical markets – with one of the world’s largest and most stable economies, high healthcare standards, and a growing demand for innovative medicines. Successfully entering this market opens new opportunities and increases Arterium’s attractiveness in the eyes of international partners,” summarizes Olena Chervonenko, Head of the Strategic Marketing Service.