Pharma Legal Handbook 1. What are the basic requirements to obtain patent and trademark protection? Under the Patent Act (Official Gazette of the Republic of Serbia, nos. 99/2011, 113/2017 – other act, 95/2018, 66/2019 and 123/2021), in order to obtain patent protection for an invention, the invention must satisfy the basic requirements of…
Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? There is an overall tendency by the Government to improve the healthcare system in Serbia, especially through digitalization and investments into creating conditions for biotechnology and innovative therapies. Regarding legislative changes, a new medicines act has been…
Pharma Legal Handbook Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Yes, cannabinoid-based medicines may be authorised, under the requirements prescribed by the relevant legislation. Cannabinoid-based substances are classified as the psychoactive controlled substances that are regulated by the Psychoactive Controlled Substances Act (“Official Gazette of the Republic of Serbia”, no.…
China Writing exclusively for PharmaBoardroom, Song Ruilin of the China Pharmaceutical Innovation and Research Development Association (PhIRDA) outlines some of the key improvements and optimisations in the regulatory landscape for pharmaceutical innovation in China. Professor Song also notes the major impact that Chinese innovation is having on global R&D pipelines and…
Saudi Arabia As Managing Director for Healthcare at Accenture Middle East, Samar Nassar oversees the global consultancy’s healthcare practice in the region, focusing on end-to-end management of large clients in both public and private sectors. Nassar highlights some of the key healthcare trends and challenges in the region, including workforce shortages, mental…
Saudi Arabia Mostafa Nagib outlines Lundbeck’s strategy and growth in Saudi Arabia, emphasizing their dedication to neuroscience and expanded access to innovative treatments. He discusses the challenges in mental health awareness and stigma as well as the journey of transforming Lundbeck Saudi to adapt to the Kingdom’s rapid development, fostering an environment…
Global Writing in the June 2024 edition of ISPOR’s Value in Health journal, Nancy J. Devlin, PhD, Michael F. Drummond, MCom, DPhil, and C. Daniel Mullins, PhD look back on the history of QALYs in cost-effectiveness analysis and policy decision making, and why the backlash against QALYs in the United States…
Canada The biggest stories coming out of Canadian pharma and healthcare, including AstraZeneca’s acquistion of Canadian biotech Fusion Pharmaceuticals; Valeo Pharma’s new senior executive and board of directors, and generics maker Apotex’s bid for Searchlight Pharma. Canada, UK launched joint probe into 23andMe data breach, says Canada (Reuters) The Canadian and…
Mexico Federico Prince, general manager and CEO of Laboratorios Kener details the family-run branded generics company’s changing of hands and the rocky patches it went through before becoming the second-largest company in Mexico’s injectables market. He also relates Kener’s “Mexico plus” approach aimed at expanding reach beyond Mexico while maintaining a…
Saudi Arabia CEO of King Saud University Medical City (KSUMC), Dr Ahmad Hersi, provides an overview of the prominent hospital group and Saudi Arabia’s oldest and largest academic medical centre, offers insights into KSUMC’s collaborations with international organizations, its focus on prevention and pre-hospital care, and establishing itself as one of the…
Mexico Guy Jean Savoir, CEO of family-run Mexican pharma Carnot Laboratories explains the company’s USD 150 million investment in a new facility, its plans to focus manufacturing efforts on vaccines and contribute to reestablishing the country as a vaccine production hub, and Carnot’s continued focus on expanding its markets in Brazil,…
Saudi Arabia Over the past three years, Sanofi has significantly expanded its presence in the GCC region, launching 40-50 new products, including treatments for rare diseases and advancements in immunology, diabetes management, and vaccines. As Jean-Paul Scheuer explains, this expansion aligns with Sanofi’s goal to become a leading immunology company globally and…
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