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and medical clinics act (PHMCA) PHMCA, which previously regulated private hospitals and medical clinics were recently repealed in December 2023.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…
UAE Long-established as the Middle East and Africa’s leading country in terms of rapid access to biomedical innovation, the UAE is looking to bolster this positioning in the coming years. Indeed, allowing innovation to flourish – including through hosting greater numbers of clinical trials in the country and protecting intellectual property…
China Jimmy Wei founded Chime Biologics over 12 years ago with the vision of establishing a global biologics company in China, focusing on biosimilar development and CDMO services. The company’s growth since then has been influenced by the success of other biologics companies like WuXi Biologics and Samsung Biologics, regulatory changes…
Global The US National Institutes of Health (NIH) is the largest public investor in HIV/AIDS research globally. This means that, as Director of the Division of AIDS (DAIDS) at the NIH’s National Institute of Allergy & Infectious Diseases (NIAID) Dr Carl Dieffenbach oversees a global HIV/AIDS research portfolio of more than…
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…
Global Marijn Verhoef, Director of Operations and Research at the Access to Medicine Foundation examines the interconnected challenges of drug shortages and antimicrobial resistance. Verhoef urges decisive and urgent action from the pharma companies that manufacture lifesaving antibiotics and antifungals to ensure that patients can get the right medicine when they…
Saudi Arabia Diederik Kok, Head of GCC, discusses his experience piloting Biogen’s newly established direct presence in the region and reviews its varied neuroscience landscape and the importance of tailoring the organization’s approach. He also speaks about Biogen’s commitment to conducting clinical trials in the GCC, its recent risk-sharing agreement with the…
India India faces a significant diabetes burden, with some observers even labelling the country ‘The Diabetes Capital of the World’. Around 101.4 million adults, or 11 percent of the Indian population, have diabetes. As Dr Brij Mohan, president of India’s Diabetes & Obesity Centre surmises, Indians tend to develop diabetes…
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