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Due to the nature of the healthcare and pharmaceutical industry, products and services produced for medical use need to undergo strict processes and meet certain requirements before they are allowed on the market. As the industry continues to grow and evolve, ensuring safety, efficacy, and quality through regulatory affairs management becomes even more crucial in […]

Regulatory affairs management in the pharmaceutical industry is important to ensure compliance with regulatory guidelines.

What is the therapeutic focus of your product ? Who is the intended audience? What is the price positioning?

As a global hub for pharmaceutical research, development, and manufacturing, Singapore prides itself on its stringent regulations that prioritise the safety, efficacy, and quality of pharmaceutical goods available within its borders. These strict guidelines help to safeguard public health by ensuring that residents have access to only the best and the safest products. However, this […]

Managing a successful therapeutic product licence transfer consists of 3 steps:  Seeking inform consent with Distributor , Selection of an independent license holder and Transfer operation.The licence transfer operation will require some preparation from Product Owner , current marketing authorization holder ( Existing Registrant) and new current marketing authorization holder (new Registrant) .Once the above is completed and a final confirmation from existing registrant that there is no pending renewal nor variations tied to the licences to be transferred, the existing registrant can log on to the online system known as: PRISM to execute the transfer inputting the details provided by Product Owner. Once the initiation of the transfer is performed, the new registrant will receive an email notification to log on to the system to accept the transfer to upload all the relevant documents and details provided by Product Owner. The process takes about 14 working days and both the new registrant and existing registrant will be notified of the outcome. There is currently no cost tied to this operation officially.

Managing regulatory obstacles is a key essential factor in expediting the approval of the products