The purpose of the webinar is to provide an overview of the regulatory landscape for generic drug registration in Singapore. It will allow listeners to be able to have some basic understanding on the regulatory requirements for generic drug registration in Singapore so as to enable them to prepare for their regulatory filing better. In the session, there will be some useful tips and references that attendees could take away successfully from this session.

1. Overview of regulatory landscape in Singapore

2. Definition of generic drug in Singapore

3. Type of patent

4. Type of application and evaluation pathway

5. Official timelines and fees to be collected

6. Requirements for Module 1 document

7. Requirements for Module 2 document

8. Requirements for Module 3.2.S drug substance

9. Requirements for Module 3.2.P drug product

10. Requirements for Module 3.2.R product interchangeability

11. Regulatory review process and what to expect

12. Tips for successful submission

13. Useful References