Introduction to Generic Drug Registration in Singapore
[Thursday, 6th Apr 2023]
Introduction to Generic Drug Registration in Singapore
Verlene Law
The Reg Consultants Pte Ltd (TRC)

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

Verlene Law
Regulatory Consultant and Director
Ms Verlene Law is an experienced regulatory affairs expert versatile in managing regulatory submission for both therapeutic products and medical devices across a different therapeutic areas in ASEAN. Her working experiences in both MNCs and SMEs has equipped her with various skills such as negotiation, presentation, project management and problem solving skills to support companies in managing their product lifecycle management for both pre-submission and post submission activities. She is a quick-witted person that is approachable, possess excellent communication skills and easy to work with.
If you have any question about this webinar, please contact us:
+86 (0)571 8710 3829