A2349C:Regulatory Affairs Plan for Glucura – Licensing and Approval Process| Case Study, AY2024 Term 4

Case Study

Singapore-based company, Cura Pharmaceuticals, has local research, manufacturing, and warehousing facilities. They recently completed clinical trials for their new anti-diabetic drug, the first in its pharmacological class, and have decided to name the product Glucura.

As the Regulatory Affairs Manager at Cura Pharmaceuticals, your task is to navigate the Health Sciences Authority (HSA)’s licensing processes to obtain approval for the manufacture, distribution, and sale of Glucura in Singapore. You are responsible for ensuring that Glucura complies with all the regulatory requirements and successfully obtains this product’s required registration and licences.

You are to prepare a set of no more than 10 presentation slides to present your plan to obtain the necessary approvals for Glucura to the management of Cura Pharmaceuticals.

Some guidelines to help you prepare your plan are as follows:

• Identify the type of product that Glucura is, in legislative terms.
• Identify which legislation or guidelines Glucura is regulated under.
• Identify the required registration and/or licensing for Glucura, taking into account all the relevant requirements, guidelines and/or exemptions for each of the procedures.
• Include any other factors that Cura Pharmaceuticals needs to consider while obtaining the required registration and licences for Glucura.
• Justify your points wherever necessary.

Include at least 2 references for your presentation.