News & Articles

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 […]

In recent times, we’ve received numerous inquiries about the possibility of rebranding complementary health and cosmetic products in Singapore, particularly due to geopolitical factors. Many companies are looking to facilitate export to their home countries, and understanding how to rebrand products as “Made in Singapore” can be a strategic advantage. In this article, we’ll explore […]

Previously, drug substance manufacturers submitting applications for new drugs, generic drugs, or minor variations involving the introduction or change of a drug substance (DS) manufacturer were not required to provide GMP evidence. However, starting from October 1st, it is essential to note that GMP compliance evidence will be mandatory for these submissions in Singapore. This […]

  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 […]