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Brazil pharmaceutical companies offer a diverse and innovative portfolio of products. However, due to geographical distance, most companies focus on developing their market within Brazil and the U.S. There are many compelling reasons for Brazilian companies to consider expanding into Singapore and other ASEAN countries, where they can leverage strategic regulatory advantages and market opportunities […]

Have you ever wondered what the difference between the terms “biosimilar” and “generic drugs” is? In the pharmaceutical industry, the distinctions between biosimilar and generic drugs play an important role in affecting healthcare accessibility and affordability, particularly in the context of pharmaceutical product registration. This guide explores the contrasting regulatory frameworks for biosimilars and generics, […]

  Entering a new market like Singapore can indeed be a strategic move for Chinese pharmaceutical companies expanding into Southeast Asia. Today TRC would like to highlight 6 key areas from a regulatory perspective: 1. Quality of the CMC documents- Drug Substance a)     GMP Compliance: Starting from October 2024, compliance with Good Manufacturing Practice (GMP) […]

  All overseas manufacturing sites are subjected to GMP conformity assessment by the local authority. GMP conformity assessment is in support a therapeutic product registration. Only local registered entity in Singapore can support the GMP conformity assessment application. The cost and timeline is dependent on the pathway in accordance to the pathway.   What is […]

  The ASEAN Joint Assessment Procedure is a procedure in which the same marketing authorization application is simultaneously submitted to all participating ASEAN National Medicines Regulatory Authorities (NRAs). ASEAN National Medicines Regulatory Authorities (NRAs) includes: Health Sciences Authority (HSA)- Singapore National Pharmaceutical Regulatory Agency (NPRA)- Malaysia Thai Food and Drug Administration (Thai FDA) Food and […]

As a country facing an ageing population and a growing incidence of chronic diseases, it is unsurprising that various pharmaceutical businesses seek to make their products available in Singapore to meet the increasing demand for advanced medical treatments. However, the selling of new pharmaceutical products is heavily regulated in Singapore and is only permitted after […]