Supporting Innovation and Timely Access
The Health Sciences Authority is committed to advancing public health and safety in supporting novel and innovative product development. HSA aims to facilitate the efficient development and timely registration of beneficial innovative therapeutic products (chemical and biologic compounds) in Singapore. To meet this aim, HSA has set up an Innovation Office in the Health Products Regulation Group 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 widen the scope (e.g. to include advanced therapy products such as cell, tissue and gene therapy products), further improve process efficiency and to better meet stakeholder needs.
This office will work closely with researchers across the 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.
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 ultimately pursue product registration in Singapore.
Types of Support and Advice Available
The Innovation Office enables individuals, researchers or companies to proactively engage with HSA on the regulatory requirements and seek early guidance on technical or scientific issues that you need to consider during the development of your product. These could cover:
- Non-clinical development
- Clinical development
- Quality development i.e. Chemistry, Manufacturing, and Controls (CMC)
- Manufacturing and Good Manufacturing Practice (GMP)
- Regulatory submissions
Submitting Queries and Scheduling of Meetings
The Innovation Office will act as the point of contact for queries and requests for advice in relation to innovative therapeutic products. You can e-mail us at HSA_InnovationOffice@hsa.gov.sg.
The following information will be useful to facilitate a more timely response to your queries, as well as to enable efficient and productive meetings, and should be provided at least 2 weeks prior to the meeting:
- Description of your company or institution
- Description of the drug product (including product description, targeted indication(s), stage of development)
- Specific questions to be addressed (e.g. relating to non-clinical, clinical, quality, manufacturing requirements)
- Briefing information relevant to the questions raised (including your position(s) on the question(s) and justification(s), where relevant)
The Innovation Office aims to respond to your queries as soon as possible, depending on the volume of queries received and within available resources. If a longer review period is necessary, we will inform you of the expected timeline for responding. All queries and information provided will be treated as confidential.