Tagged with EG

Switzerland Daniel Weber of Boehringer Ingelheim Switzerland explores the company’s strategic initiatives and focus on innovation within the Swiss healthcare system. Weber emphasizes Boehringer Ingelheim’s long-term vision of transforming lives, its commitment to early diagnosis, and its expanding role in digital health.   Our purpose and strong pipeline are what truly…

Switzerland Incyte’s Jonathan Dickinson discusses the company’s mission to address unmet medical needs in oncology and autoimmune diseases while expanding its footprint across Europe. He highlights the strategic role of Incyte’s internal research, clinical trials, and recent product launches, along with their ambitions to double European revenues in the coming years.…

Switzerland Johnson & Johnson Innovative Medicine’s Max Pahlow discusses how the company’s commitment to innovation and patient care drives its success in Switzerland. He highlights the importance of advancing clinical trials, digitalization, and modernizing the pricing and reimbursement system to maintain Switzerland’s competitive edge in healthcare.   Switzerland isn’t a lucky…

Mexico The lowest spender on healthcare as a percentage of GDP in mainland Latin America. A complex and fragmented reimbursement system. Clinical trial approval delays stretching across eight months. One could be forgiven for thinking that attempting to bring innovative medicines to Mexico is a thankless task. Yet, as several country…

Switzerland Thomas Wirth shares insights into Biomed’s strategic focus on the Swiss pharmaceutical market, offering comprehensive services from regulatory support to market access for RX and OTC products. He discusses Biomed’s commitment to long-term partnerships, technological advancements, and driving operational efficiency to stay competitive.   At Biomed, we prioritize delivering value…

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…

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? The authorization process for marketing new drugs, biologics, medical devices, OTC, and other medicinal products is through a marketing authorization as detailed in question 3 of Chapter 1.  …

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.