The Health Sciences Authority (HSA) is the agency responsible for regulating medicinal and health products in Singapore, including cellular therapy products. HSA also regulates traditional pharmaceutical drugs, complementary medicines, medical devices and other health products to ensure they meet appropriate safety, quality, and efficacy standards. HSA runs the national blood bank and oversees transfusion medicine services in Singapore.
At the time of this writing (August 2013), legislation and regulations for human cell- and tissue-based therapy (CTT) products are being developed. The regulations for CTT products are being phased-in and currently, only some parts of the regulatory framework for cellular therapies have been become effective. HSA has proposed to use a tiered, risk-based approach to the regulation of CTT products similar to that used in the United States. Brief summaries of current applicable regulations for CTT products are provided below along with prospective regulations and how they are envisioned to be developed.
The Medicines Act
The Medicines Act (MA) of 1975, as amended, grants HSA the authority to regulate the manufacture, import, supply, and license and certificate requirements of medicinal products in Singapore. A medicinal product is any substance or article (not being an instrument, apparatus or appliance) that is manufactured, sold, supplied, imported, or exported and is either for use by being administered to one or more human beings or animals for a medicinal purpose, or for use as an ingredient in the preparation of a substance. Currently, only high-risk CTT products are regulated as medicinal products, more specifically as biological medicinal products, to ensure quality, safety, and efficacy. High-risk CTT products are products that have been substantially manipulated, are intended for non-homologous use, or are combined or used in conjunction with a drug, biologic, or medical device. High-risk CTT products are also subject to clinical trial (see below) and Good Manufacturing Practice regulations, and must be licensed before entering the commercial market.
Clinical Trial Regulations
The requirements for conducting clinical trials in Singapore are described in the Medicines (Clinical Trials) Regulations of 2007, which is subsidiary legislation to the MA. In order to conduct a clinical study in Singapore, the applicant must first receive a Clinical Trial Certificate (CTC) from HSA. Before initiating a clinical study involving an investigational CTT product in Singapore, the risk of the product must first be determined by HSA. The risk classification of the CTT product is determined on a case-by-case basis at a pre-submission meeting between HSA and the applicant. If HSA determines that the CTT product is low-risk at the pre-submission meeting, the applicant does not need to obtain a Clinical Trial Certificate from HSA prior to initiating a clinical study. However, if HSA determines the CTT product is high-risk, then the applicant must obtain a CTC in order to start a clinical study. Regardless of risk level of the CTT product, clinical trials of an investigational CTT must be approved by an Institutional Review Board.
Future Regulatory Perspectives
The Health Products Act (HPA) of 2007, as amended, provides mechanisms for categorizing health products in accordance with their charactersisitcs and uses, establishes a uniform framework for registering health products, and sets up a framework for regulating the manufacture, import, supply, storage, presentation, and advertisement of health products. A health product, which is a category of a medicinal product, is any substance, preparation or device that is intended to prevent, diagnose, monitor, treat, cure, or alleviate any disease, disorder, ailment, injury, handicap, or abnormal physical or mental state, or the symptoms thereof, in humans. As noted above, HSA is in the process of developing and phasing-in CTT product-specific subsidiary legislation, which will be established under the HPA and will allow for CTT products to be regulated as health products.