Tagged with ARM

Pharma Legal Handbook An insight into orphan drugs and rare diseases in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.   1. What is the definition of Rare Diseases in your country? Pursuant…

Pharma Legal Handbook 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 a statutory board of the…

Pharma Legal Handbook 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, medical technology companies, biotechnology companies…

Pharma Legal Handbook 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 Authority (HSA) for product registration. The applicant (or product registrant) must…

Pharma Legal Handbook 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 1975, the Medicines (Advertisement and Sale) Act 1955, the Sale of Drugs Act 1914and…

Pharma Legal Handbook 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 devices? An action…

Pharma Legal Handbook 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 in Singapore. An individual, firm or…

Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? Introduction of the Healthcare Services Act (HCSA) and repeal of the Private Hospitals and medical clinics act (PHMCA) PHMCA, which previously regulated private hospitals and medical clinics were recently repealed in December 2023. The HCSA came into…

Pharma Legal Handbook A legal and regulatory guide to cannabinoid drugs, medicinal cannabis and opioids in Singapore. This is an extract from the Pharma Legal Handbook Singapore, available here.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In general, Cannabinoid Drugs are not authorised in Singapore. The Misuse of Drugs…

Pharma Legal Handbook 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 rare disease as a condition that affects…

Pharma Legal Handbook 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 cells through highly specific processes. Even a…

China Boan Biotech CEO Jiang Hua outlines the Luye Pharma-acquired company’s approach, securing stable revenues through its biosimilars while pursuing novel platforms and innovative drug development. She provides insights into the biotech’s six biosimilar products, as well as its main technology platforms – including the foundational Human Antibody Transgenic Mouse platform…