Tagged with EG

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and medical clinics act (PHMCA) PHMCA, which previously regulated private hospitals and medical clinics were recently repealed in December 2023.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 Since first establishing an affiliate in China back in 2017, Gilead Sciences has been able to introduce 11 innovative medicines to the Chinese market – eight of which have been included in the National Reimbursement Drug List – across HIV prevention & treatment, viral hepatitis, invasive fungal disease, and cancer.…

China Unlike many of its Chinese biotech peers with broad portfolios, Hua Medicine has focused intensively on developing a single product, dorzagliatin, for diabetes. As CEO Li Chen notes, this strategic concentration has allowed Hua Medicine to pioneer in homeostasis control modulation and address specific unmet medical needs in diabetes treatment,…

China Yoshitaka Koketsu explains Sumitomo Pharma Group’s positioning in the China market as a relatively recent market entrant with a six-product portfolio but with plentiful opportunities for further growth, particularly in combating infectious diseases and antimicrobial resistance (AMR). Koketsu outlines how the company is well-aligned with China’s regulatory changes, and how…

LatAm For the second consecutive year, DIA Europe hosted a Latin America Town Hall, a panel discussion to foster collaboration and share updates from regulatory activities in Latin America and Europe, and the intersections between them. MSD’s Leonardo Semprun, writing in the May 2024 edition of DIA’s Global Forum magazine, highlights…

China HKEX-main board listed Alphamab Oncology is one of China’s leading biotech success stories, having developed and marketed the world’s first subcutaneously injectable PD-L1 inhibitor. Founder, Chairman, and CEO Dr Xu Ting outlines some of the key recent trends in the Chinese biotech ecosystem, the funding challenges associated with running clinical trials…

China Chinese player Legend Biotech reached a new turning point last month when its Johnson & Johnson-partnered Carvykti became the first BCMA-targeted CAR-T cell therapy to be approved by the FDA for second-line treatment of multiple myeloma. From its original roots in China to its first FDA approval in 2022, the…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport) The policy and regulation of drugs (‘medicinal products’), biologicals and medical devices falls under the jurisdiction of the Ministry of Health,…

Saudi Arabia Last year, Dimitri Livadas made the unconventional leap from Big Pharma to a local Saudi firm, Saudi Chemical. In conversation, he explains the motivating factors behind this decision, including Saudi Arabia’s vision for the future, the legacy and growth potential of Saudi Chemical, and the unique opportunity to be part…