Tagged with HAI

China A summary of top stories from China’s pharma industry: Sciwind Biosciences presents promising trial data for its obesity contender; Simcere reaches approval for its Idorsia-partnered insomnia therapy; AstraZeneca inks AI-enabled research deal with CSPC Pharmaceuticals, and the FDA blocks clinical trials that export American’s cells to China. Sciwind’s GLP‑1 data…

Puerto Rico From its origins as a modest logistics firm in 1982, GMD Airline Services has grown into a critical enabler of Puerto Rico’s pharmaceutical and medical device supply chain. At the intersection of ground handling, cold chain operations, and air cargo connectivity, GMD’s evolution reflects the broader shifts in the island’s…

Switzerland The transformation of CEVA Logistics’ healthcare strategy – led by industry veteran Eric ten Kate – is unfolding with quiet precision and sharp focus. As part of the CMA CGM Group and with a mandate rooted in operational excellence, digital intelligence, and regional depth, CEVA is redefining its position in…

Denmark Flemming Sonne, CEO of Amgros, Denmark’s central pharmaceutical procurement organization for hospital medicines, outlines the organisation’s evolving role in ensuring affordable and sustainable access to medicines. In this interview, Sonne discusses Denmark’s forward-thinking approach to supply chain resilience, the integration of ATMPs and innovative access models, and the increasing convergence…

Switzerland SkyCell is at the forefront of a fundamental shift in pharmaceutical logistics, where AI, real-time monitoring, and sustainability are no longer optional but essential. As pharmaceutical supply chains grow more complex, the need for precision, resilience, and carbon-conscious innovation has never been greater. With AI-driven optimization redefining efficiency and risk…

Global As healthcare systems grapple with rising costs and the need for broader access to treatment, off-patent medicines have taken on increasing importance. With budgets under pressure and blockbuster drugs losing exclusivity, the generics market is on track to reach USD 600 billion by 2033, with these five players leading the…

China A roundup of some of the biggest stories coming out of China’s pharma industry, including the news that AstraZeneca may be seeing the other side of country’s probes; the counter-sanction of US biotech Illumina; Bio X Cell’s new Beijing distribution centre, and the European approval of Shanghai Henlius Biotech’s extensive-stage…

Pharma Legal Handbook   What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Thailand, drugs, biologics, and medical devices are regulated by the Thai Food and Drug Administration (Thai FDA), under the supervision of the Ministry of Public Health (MOPH). More precisely, the Drug Division…

Pharma Legal Handbook Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, the clinical trial does not need to be conducted locally in order to obtain marketing approval. The Thai FDA only requests that clinical data be arranged in either the format of Part…

Pharma Legal Handbook What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Pharmaceutical Products The authorization processes for the marketing of new drugs, biologics, over-the-counter medications, and other medicinal products are the same. Companies and individuals that wish to place a drug…

Pharma Legal Handbook What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In April 2019, the Thai FDA published and implemented the Herbal Product Act. This is now the main act regulating herbal or traditional medicine in Thailand. The authorization process for the marketing of traditional medicines and…

Pharma Legal Handbook What types of liability are recognized in your jurisdiction? The laws of Thailand provide for civil, criminal, and administrative liabilities. Fundamentally, product liability is recognized as part of sales and contract law wherein the seller shall be liable to the buyer for a damage caused by deficient goods. This liability…