Pharma Legal Handbook 1. What are the basic requirements to obtain patent and trademark protection? As a rule, a patent or a trademark protection can only be obtained by registration with the State Office for Inventions and Trademarks (“OSIM”), based on the specific provisions stipulated by Law no. 84/1998 on trademarks and geographical…
Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? The Romanian authorities announced their intention to implement certain changes in the pharmaceutical legislation, including in relation to: the new advertising norms for medical devices, which will bring significant changes in connection with the marketing and advertising…
Pharma Legal Handbook Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? According to the national catalogue of medicines in Romania published by NAMMD, currently there is one medicinal product authorized for marketing in the country having as active substance cannabidiolum. By law, certain narcotic or psychotropic substances extracted from cannabis, such…
Pharma Legal Handbook 1. What is the definition of Rare Diseases in your country? Regulation (EC) no. 141/2000 on orphan medicinal products (“Regulation no. 141/2000”), which is directly applicable in Romania, specifies that a medicinal product could be designated by the European Medicines Agency as an orphan medicine when: (i) it is intended…
Pharma Legal Handbook 1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Romania has a favourable tax regime for companies, which encourages many businesses to set up and to operate subsidiaries in Romania. However, there are no…
Pharma Legal Handbook 1. Are biosimilar medicines considered the same as generic medicines in your country? The biosimilar medicinal products are not considered the same as generic medicinal products, since the Romanian legislation regulates biosimilars and generics in a different manner. As per the local legislation, a biosimilar is a biologic medicinal product…
Japan Japan was once a global leader in life sciences innovation, introducing about a third of the world’s new drugs in the 1980s, but this positioning slipped following decades of economic stagnation compounded by a conservative regulatory regime. However recent regulatory reforms have brought a more positive outlook and sparked a…
China China’s position as one of the leading global sources and recipients of biopharmaceutical innovation is inarguable. However, in the new Year of the Snake, geopolitical and economic uncertainties are swirling, calling some to question the role that the country can continue to play in global health. Despite these challenging times,…
Puerto Rico Could the future of metastatic cancer treatment lie in a groundbreaking compound developed in Puerto Rico? Dr. José F. Rodriguez-Orengo, CEO of MBQ Pharma, leads the development of MBQ-167, a first-in-class therapy designed to disrupt cancer progression. As the company navigates challenges in funding, it is also paving the way…
Global The 2025 Davos World Economic Forum brought together business leaders from multiple industries to debate the challenges and issues facing the world today. The Pharma CEOs in attendance discussed critical topics such as the impact of climate change on health, AI-driven innovation, and the complexities of global trade tensions, all…
Saudi Arabia Amgad Talaat, Regional Cluster Head of EVA Pharma Saudi Arabia, delves into the company’s strategic expansion in the region, emphasizing investments in local manufacturing, innovation, and team development to align with Saudi Vision 2030. With a focus on addressing unmet medical needs and fostering partnerships, EVA Pharma is positioning itself…
Brazil A roundup of the biggest stories from Brazil’s pharma industry, including Teuto’s cannabis manufacturing deal with MediPharm; Eurofarma’s AI-based epilepsy joint venture with SK Biopharmaceuticals; EMS’s increased stake in Hypera after a failed merger attempt, and Quantoom, Univercells and Fiocruz’s RNA-based vaccine production collaboration. MediPharm Labs Enters Landmark Commercial…
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