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This is to inform concerned stakeholders of the compliance to Administrative Order (AO) No. 2014-0016 entitled Adoption of the World Health Organization, “Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)” for the Registration of Biosimilar Products which directs all manufacturers, traders and distributors (exporters, importer, wholesaler) of biosimilar products to adopt the current version of the WHO “Guidelines on Evaluation of Biosimilars” (2022).

EU MDR transition extension

The TGA recently implemented an EU MDR transition strategy for Australian medical device sponsors and stakeholders. More recently, the EU extended the transition, prompting the TGA to review its strategy, and to review the impact on reclassification reforms underway in Australia.