Tagged with ARM

Pharma Legal Handbook   What is the definition of Rare Diseases in your country? There are no legal documents in Vietnam providing a definition of “rare diseases.”   Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?) An orphan drug is a drug…

Puerto Rico With lower labour costs than mainland US, but the same regulatory framework and straightforward market access, Puerto Rico has long presented a compelling value proposition for pharmaceutical manufacturing, a sector that accounts for some 30 percent of the island’s GDP.  After bouncing back from bankruptcy, devastating hurricanes and the COVID-19…

Switzerland Stefan Berg, General Manager of Pharmaplan AG, offers insight into the company’s transformative journey as it becomes part of Exyte Group, a global leader in advanced engineering. Berg discusses Pharmaplan’s growth strategies, the evolving landscape of pharmaceutical manufacturing, and the shift towards local production, particularly in Switzerland. He also highlights…

Switzerland Dr Michael Quirmbach of CordenPharma discusses the company’s ambitious goal to become one of the top five CDMOs globally, emphasizing the importance of strong scientific expertise and customer-centricity in their operations. Dr Quirmbach highlights the significance of adapting to market demands and maintaining high compliance standards while fostering strategic partnerships.…

China A roundup of some of the top stories coming out of China’s pharma industry, including AstraZeneca’s USD 1.92 billion deal with CSPC; Bayer’s new Shanghai incubator; Genentech’s purchase of Regor Pharmaceuticals’ breast cancer portfolio; Shanghai Fosun Pharmaceutical’s African manufacturing expansion, and CanSino’s USD 17 million polio vaccine grant from the…

Hong Kong Hong Kong has grand plans to become one of Asia’s leading clinical trial hubs. Important regulatory upgrades and increased integration with mainland China via the Greater Bay Area initiative – including a new dedicated GBA Clinical Trial Institute at the Hong Kong/mainland border – mean that this is not just…

Switzerland Switzerland is widely praised for its excellent universal healthcare system and strong pharma sector. Seen as a bastion of efficiency and innovation, the country is nonetheless falling behind its European counterparts when it comes to healthcare digitalisation. Recent PharmaBoardroom interviewees weigh in on the country’s digital lag, its electronic patient…

LatAm An overview of some of the biggest news from Latin American pharma, including Onconic Therapeutics’ licensing deal with Laboratorios Sanfer for 19 LatAm countries; Lupin’s orphan drug partnership with Argentina’s Celnova Pharma; Grifols’ distribution deal with Gema Biotech; the downturn in Uruguay’s medicinal canibis industry, and Novartis’ increased clinical trial…

Switzerland Dr René Buholzer, CEO of Interpharma, covers Switzerland’s healthcare advancements, regulatory progress, and the challenges in drug access and digitalization over the past three years. Emphasising collaboration and innovation, Interpharma’s ‘Pharma Strategy 2030’ aims to solidify Switzerland’s leadership in R&D and healthcare sustainability.   Our vision is not just about…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA), a decentralized Health Ministry (HM) agency, is responsible for applying and enforcing the regulatory framework regarding human medicines, biologicals, and medical devices.  …

Pharma Legal Handbook As a general introduction, clinical trials are regulated in Ecuador via the Ministerial Agreement (MA) 0075-2017 and reform 0006-2020, which relates to regulations for approving, developing, monitoring, and controlling clinical trials. This regulation was enacted on June 30th, 2017. Other rules and regulations make MA 0075-2017 enforceable. The Constitution of…

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The General Health Law (HL) and its regulations govern traditional, complementary, and alternative medicines. These medicines are known as natural, whose active ingredients are formed by any part of natural medicinal resources or combinations thereof,…