Legal & Regulatory > Singapore

A brief overview of the situation regarding biosimilars & biologics in Singaporean Pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.   1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar medicines are not considered the same as generic medicines. According to the Health Sciences Authority of Singapore (“HSA”), biologics are medicinal products with large complex molecules produced by living…

The ins and outs of orphan drugs & rare diseases in Singaporean Pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.   1. What is the definition of Rare Diseases in your country? As at the date hereof, there is no legal definition of rare diseases in Singapore. In a press release dated 2 July 2019, the Ministry of Health of Singapore (“MOH”) defined a…

Cannabinoid drugs, medicinal cannabis and opioid drugs in Singaporean Pharma – a legal guide. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In general, Cannabinoid Drugs are not authorised in Singapore. The Misuse of Drugs Act (Chapter 185) of Singapore (“MDA”) prescribes that it shall be an offence to traffic, manufacture, import or export,…

Upcoming regulatory reforms in Singaporean pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? PROPOSED HEALTHCARE SERVICES BILL Currently, hospitals and private medical clinics are regulated under the Private Hospitals and Medical Clinics Act (PHMCA), which was first enacted in 1980. Since then, there have been significant changes to the healthcare…

What you need to know about patents and trademarks in Singaporean pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? The relevant applications must be filed with the Intellectual Property Office of Singapore (IPOS) in order to obtain protection for patents in Singapore. It is not compulsory to register a trade mark…

Key legal info on product liability in Singaporean pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? In Singapore, product liability in relation to medicines can arise under an action in tort, contract and/or breach of relevant statutory provisions.   2. How do these types of liabilities apply to the manufacturers of medicines and…

Want to know more about traditional medicines and OTC products in Singapore? Read on! Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Chinese proprietary medicines, traditional (Indian and Malay) medicines, homeopathic medicines and medicated oils and balms are regulated under the Medicines Act (Chapter 176), the Medicines (Advertisement and…

Everything you need to know about the marketing, manufacturing, packaging, labeling and advertising of pharmaceuticals in Singapore. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? THERAPEUTIC PRODUCTS For therapeutic products, marketing approval may be obtained by making an application to the Health Sciences…

The key facts about conducting preclinical and clinical trials in Singapore. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, there is no such express statutory requirement under Singapore legislation.   2. How are clinical trials funded? Clinical trials may be funded by pharmaceutical companies, hospitals,…

All about regulation, pricing and reimbursement in Singaporean pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The key regulatory authority with jurisdiction over drugs, biological and medical devices in Singapore is the Health Sciences Authority (HSA). It was established on 1 April 2001 as…