News & Articles

  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 […]

It has come to the end of the year where budgeting and planning are in full force for 2024.  In regulatory, we do it via the RPA way which stands for Review, Plan and Act . TRC shall share a short summary on what RPA means : Review Start off with product annual review to […]

During the expansion of territory in the traditional  business model, there will be multiple distributors that manufacturers must deal with. Unlike big companies that have a dedicated staff looking after the region. Smaller companies  or companies that do not have a local office established in the territory will rely on their business manager who might […]

The next step after performing a regulatory intelligence exercise would be followed by an arrangement for a consultation with the regulatory authority. This is common especially for IND application and NDA application in which there may be concerns regarding the documentation requirements or even addressing any critical CMC, pre-clinical and clinical study related questions. Today […]