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Europe Dr Carolyn H. Rogers, Rushikesh S. Dasoondi and Dr Michael A. Roberts from UK and European intellectual property law firm Reddie & Grose LLP examine the intersection of personalised medicine and rare diseases and its implications for IP law.   Personalised medicine, also referred to as precision medicine, is an…

Europe Will a new ‘Critical Medicines Act’ go far enough to ensure Europe’s resilience to future health crises?   A Continent at Risk The COVID-19 pandemic exposed serious vulnerabilities in the European medicine supply chain. EU countries suddenly found themselves competing for limited supplies of sedatives and antibiotics for ICU care,…

Saudi Arabia Daniel Vella Friggieri, Regional CEO for Europe and the Middle East at Aspen Pharmacare, discusses the company’s growth trajectory over the past 18 months, highlighting the decision to merge the Middle East and European regions into one unit. He reflects on Aspen’s evolving approach in Saudi Arabia, covering localization, talent…

MEA Mohammad El Khoury, General Manager of GE HealthCare in Saudi Arabia, explores the company’s evolution—from adopting direct distribution models to pioneering AI-powered diagnostics—while aligning with Vision 2030. By forging strategic public–private partnerships, enhancing training programs, and fostering a culture of accountability and innovation, GE HealthCare is contributing to reshape the…

Puerto Rico CDI Labs, founded in 2008 in Mayagüez, Puerto Rico, is a specialized CRO focused on drug development and clinical-stage research, particularly in antibody specificity, biomarker exploration, with emphasis on autoimmune diseases and immunoncology. CDI is leveraging proprietary technologies like its “human on a chip” system to analyze protein interactions and…

Asia A whistlestop tour though the latest news from pharma in Asia, taking in the American gene sequencing giant caught in the crosshairs of the US-China tariff row, the ADC-focused Singaporean biotech getting a 187 million dollar funding boost, why the Australian regulator has rejected Eisai’s Alzheimer’s drug, the activist fund…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authorities competent in these fields are: the Ministry of Health (http://www.ms.ro/); the National Agency for Medicines and Medical Devices (https://www.anm.ro/); and the National Health Insurance House (http://www.cnas.ro/).   2. What is…

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? The Romanian law does not expressly provide such limitation as to the performing of clinical trials solely in Romania in view of obtaining the marketing authorization for a certain medicinal product.  …

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Health Law transposed into the national legislation the provisions of Directive 2001/83/EC on the Community code relating to medicinal products for human use, and provides specific rules for the traditional herbal medicinal products and…

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? The failure to comply with the Romanian pharma legislation can trigger disciplinary, civil, material, contraventional or criminal liability, depending on the case. Additionally, the competent authorities in various fields can apply fines and other sanctions when the breach is related…

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…