Tagged with Singapore

Singapore Charles Stacey, President and CEO of Cerecin, discusses the company’s strategic direction and partnerships as it advances its Alzheimer’s treatment into Phase 3 trials. He highlights the importance of collaboration with global contract research organizations and large vendors during the clinical development phase. Stacey also shares insights into Cerecin’s approach…

Singapore Thanks to its strategic location and pro-business environment, Singapore has established itself as a major pharma manufacturing hub in the Asia-Pacific region. Five Big Pharma companies have stepped up their investments there as of late and either expanded existing manufacturing capabilities, or chosen the city-state as the location for a…

Asia A whistlestop tour though the latest news from pharma in Asia, taking in the American gene sequencing giant caught in the crosshairs of the US-China tariff row, the ADC-focused Singaporean biotech getting a 187 million dollar funding boost, why the Australian regulator has rejected Eisai’s Alzheimer’s drug, the activist fund…

Singapore Writing in the November 2024 edition of DIA’s Global Forum magazine, Johnson & Johnson’s Sandy Chan looks at the fast-evolving regulatory framework for medicines in the dynamic Asia-Pacific region.   Asia Pacific (AP) is an immensely diverse and dynamic region with varying regulatory capabilities and capacities; consequently, AP regulators and…

Global AstraZeneca’s Anna Litsiou, Carolyn Hynes and Allison Guy, contributing to the September 2024 edition of DIA’s Global Forum magazine, discuss the importance of improving interactions between health technology assessment (HTA) bodies and regulatory authorities.   The need to optimize drug development and facilitate faster access for patients has focused discussions…

APAC A run-through of some of the most striking recent stories from pharma in the dynamic Asia-Pacific region, including Japan’s attempts to bring back Big Pharma investment; UCB’s decision to divest its China neurology and allergy business for USD 680 million; and Pfizer, AstraZeneca and Novartis investing in Singaporean manufacturing.  …

APAC A roundup of the biggest pharma stories coming out of APAC, including Eisai’s deal with biotech SEED Therapeutics and share drop after Alzheimer’s rejection in the EU; Mayne Pharma’s lawsuit against Sun; Novo Nordisk’s insulin partnership with Bio Farma, and Celltrion’s resturcturing.   Amid GLP-1 boom, Novo Nordisk strikes up…

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…