Tagged with

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…

France At the end of a turbulent and lengthy process, France’s 2025 health budget has finally been approved. This “imperfect” budget resulting from months of debate in a parliament with no absolute majority does not embrace the more radical cost-cutting measures originally proposed. It does raise funding for hospitals by EUR…

USA The US pharmaceutical industry is scrambling to align with President Donald Trump’s policy agenda, but may not get all it wishes for…   In its first few weeks in power, the emboldened second Trump administration has enacted a scattergun set of executive orders, covering everything from swingeing cuts to the…

Puerto Rico In a rapidly evolving global landscape, medtech manufacturer Copan Industries (part of Copan Group) has strategically chosen Puerto Rico as a key hub for its expansion in the Americas, attracted by the island’s skilled workforce and strong institutional support. As COO Efraín Rodriguez explains, with over $100 million invested, the…

Saudi Arabia Dr Abdulaziz Alswailem, the CEO of the Saudi Authority for Intellectual Property (SAIP), reflects on the country’s growing role in global intellectual property (IP) policy. He highlights Saudi Arabia’s efforts to foster a strong IP ecosystem through national and international collaborations, such as the Riyadh Design Law Treaty, which sets…

Saudi Arabia Dr. Helmut M. Schuehsler, CEO of TVM Capital Healthcare, shares insights into the firm’s investment strategy spanning the Middle East and Southeast Asia with a particular focus on Saudi Arabia’s rapidly evolving healthcare landscape. He discusses how TVM Capital Healthcare is driving transformation by scaling healthcare businesses, introducing innovative care…

Saudi Arabia Mohamed Fawzy, Country President for Pfizer Saudi Arabia, discusses the company’s evolving role in supporting the Kingdom’s rapidly transforming healthcare sector. He shares insights on Pfizer’s local footprint, its contributions to public health through innovative vaccines and oncology treatments, and the company’s commitment to talent development and localization. Fawzy also…

Global Since Paul Hudson took the helm in 2019, Sanofi has been in transformation mode, shedding its consumer health assets to focus on high-growth areas like oncology, immunology, and vaccines. With bold investments in R&D and AI-driven innovation, the French pharma is positioning itself as a pure-play biopharma leader. In conversation…