Author: Lawyer Zhang Jingxinyue, PRC-qualified Lawyer | Singapore Registered Foreign Lawyer
Note: Singapore is a city-state in Southeast Asia and a founding member of ASEAN. It is geographically adjacent to Malaysia and Indonesia and covers an area of more than 700 square kilometers. Thanks to its stable business environment, efficient government agencies, flexible human resource policies, and convenient location, Singapore has attracted many multinational companies to establish R&D centers, regional headquarters, and production bases there.
Although Singapore has a very small land area, it has one of the largest and most advanced healthcare systems in the world, and to a certain extent, Asia as a whole relies on Singapore's sound healthcare infrastructure. Previously, we published Understanding the Basic Requirements and Registration Process for Engaging in the Medical Device Industry in Singapore | China-Singapore Legal News. This article provides an overview of the Health Sciences Authority (HSA) registration system for pharmaceuticals, medical devices, and Chinese proprietary medicines.
Currently, ASEAN does not yet have a common drug registration mechanism like the EU, nor is there a clear mutual recognition mechanism among its member states. However, obtaining a registration approval in Singapore can still carry some persuasive weight with the drug regulatory authorities of other ASEAN member states, and it is beneficial for Chinese pharmaceutical companies seeking to expand their market share in Southeast Asia.
01 Singapore’s Pharmaceutical and Medical Device Regulatory Authority
In Singapore, the government authority responsible for regulating the manufacture and distribution of pharmaceuticals, biological products, and medical devices is the Health Sciences Authority (HSA), established in April 2001.
In addition to local pharmaceutical regulatory oversight, HSA actively participates in international cooperation and is currently a member of the Access Consortium, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the International Coalition of Medicines Regulatory Authorities (ICMRA), the International Medical Device Regulators Forum (IMDRF), the ASEAN Medical Device Committee (AMDC), and other organizations.
02 Drug Registration System
In Singapore, the main drug registration routes are NDA and GDA, corresponding respectively to new drugs and generic drugs.
The general classification criteria are shown in the figure below:
Within each category, the submission requirements and approval timelines vary depending on the drug's place of manufacture and its registration status in other countries, particularly HSA's reference agencies, which currently include the drug regulatory authorities of the United States, Canada, the European Union, the United Kingdom, and Australia. Generally, if a foreign pharmaceutical manufacturer has already registered its product in one of the above jurisdictions, the workload and application fees for subsequently submitting a registration application in Singapore are relatively lower.
The general registration process is shown in the figure below:
HSA is relatively flexible with the format of submission dossiers and accepts both ICH CTD and ASEAN CTD formats. Generally, the time from submission to approval is approximately 6-18 months.
Of course, for these pharmaceutical companies, because Singapore is located in the tropics, stability testing temperature requirements are different, which is another aspect that companies intending to register pharmaceuticals in Singapore should note.
03 Medical Device Registration System
For medical devices, unlike the classification approach in China, HSA divides them into two broad categories: general medical devices and in vitro diagnostic (IVD) devices. According to their respective risk levels, they are regulated in four classes: Class A, Class B, Class C, and Class D. Class A includes low-risk devices such as tongue depressors and wheelchairs, while Class D includes high-risk devices such as implantable heart valves.
In recent years, software used for medical purposes has also been regulated as medical devices. Depending on its function and risk level, it is generally classified as a Class A or Class B medical device.
With respect to medical device registration submission materials, requirements also differ across risk classes. Currently, because Class A devices are relatively low risk, HSA only requires notification and does not conduct substantive review; for other classes, submission of registration materials for substantive evaluation may be required. Approval timelines and fees vary depending on the risk level, performance in foreign markets, and approval status with HSA's reference agencies, including the drug regulatory authorities of the United States, Canada, the European Union, Australia, and Japan.
04 Chinese Proprietary Medicines Registration System
Chinese proprietary medicines are relatively well accepted in Singapore. There are also several local manufacturers of Chinese proprietary medicines.
Chinese proprietary medicine manufacturers from China are also actively seeking to enter the Singapore market. For example, Fukangyan Capsules (Buchang Pharmaceutical) and Lianhua Qingwen Capsules (Yiling Pharmaceutical) received approvals in 2020.
Conclusion
For pharmaceutical companies outside Singapore, if they intend to register products in Singapore, the registration application must be submitted by a company registered in Singapore. They may either register a Singapore company themselves or appoint a local agent to carry out the relevant registration work.
- The above processes and requirements are for reference only. For specific data and requirements, please refer to the Health Sciences Authority website.
https://www.hsa.gov.sg/medical-devices/
- For more inquiries about Singapore's pharmaceutical industry, please contact a professional consultant at China-Singapore Legal News.
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Author | Xun Guan Jia
This article is for informational reference only and does not constitute formal legal advice.
This article is general information and not legal advice. Specific matters require assessment by appropriately qualified professionals.