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As standards of living and healthcare quality rise, the demand for pharmaceuticals, medical devices, and other medical commodities, collectively called health products, is on the rise. With more products entering the market, it’s vital to have robust regulatory systems in place to ensure timely access to safe and effective therapies. Strengthening the registration framework is […]

  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) […]

Whether it is hardware or software as a service – subscription services are rising to prominence in our daily lives. However, mention our subscription plan for regulatory affairs, and some might be left scratching their heads. While this is an understandable reaction to a layman, our subscription plan can aid businesses in need of regulatory […]

  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 […]

Regulatory compliance in the healthcare industry is essential to maintaining quality standards and preventing fraud and abuse, thus ensuring patient safety. However, local and overseas pharmaceutical and medical companies seeking to register their medical products in Singapore may find navigating the numerous regulations governing their operations overwhelming and time-consuming. Due to the dynamic nature of […]