Tagged with ARM

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,…

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? In general terms, liability arises from the Civil and Criminal Codes, and it is personal responsibility for actions or omissions. However, the Consumer Protection Law establishes that civil damages may be claimed in case of damages caused by a defective…

Pharma Legal Handbook 1. What are the basic requirements to obtain patent and trademark protection? Any sign distinguishing goods and services on the market shall constitute a mark. Signs capable of graphic representation shall be eligible for registration as a mark; in particular, the shape of a product, its packaging, or wrapping may…

Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? Since former president Lenin Moreno vetoed the Health Code bill (September 2020), no developments have occurred.   2. When are they likely to come into force? Uncertain.

Pharma Legal Handbook Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? On September 17, 2019, Congress approved a reform of the Criminal Code, which reforms included the decriminalization of possession of drugs that contain cannabis or derivatives as their active ingredient for therapeutic, palliative, or medicinal use or the practice of…