Supporting innovation and timely access
As part of our aim to facilitate the efficient development and timely registration of beneficial innovative therapeutic products (chemical and biologic compounds) and cell, tissue or gene therapy products (CTGTPs) in Singapore, we have set up an Innovation Office as a pilot to provide a conducive regulatory environment that will also support the development of the biomedical sector.
Based on the pilot, refinements may be made to further improve process efficiency, and to better meet stakeholder needs.
The Innovation Office provides scientific and regulatory advice to researchers, academia, biotechs, and pharmaceutical companies with an interest in early stage clinical product development, and with the intent to pursue product registration in Singapore.
This office will work closely with researchers across public sector research agencies and the biotech-pharma industry to offer regulatory support to facilitate the translation of scientific discoveries into clinical treatments that are beneficial to patients in Singapore.
Support and advice
The Innovation Office enables individuals, researchers or companies to proactively engage with us on regulatory requirements, and seek early guidance on technical or scientific issues that need to be considered during product development. These include:
- Non-clinical development
- Clinical development
- Quality development, such as Chemistry, Manufacturing, and Controls (CMC)
- Manufacturing and Good Manufacturing Practice (GMP)
- Regulatory submissions
Submit queries and schedule meetings
You can e-mail the Innovation Office on queries or requests to meet, in relation to innovative therapeutic products.
Please provide the following information in your e-mail to facilitate a more timely response, as well as to enable efficient and productive meetings. This information should be provided at least 2 weeks prior to the meeting:
- Description of your company or institution
- Description of the product (including product description, targeted indications, stage of development)
- Specific questions to be addressed, such as those relating to non-clinical, clinical, quality, manufacturing requirements
- Briefing information relevant to the questions raised (including your positions on the questions and justifications, where relevant)
We aim to respond to your queries as soon as possible, depending on the volume received and within available resources. We will inform you of the expected response timeline if a longer review is necessary. All queries and information provided will be treated as confidential.