Tagged with Pharm

Saudi Arabia Cooper Pharma, with its 90-year legacy, is at the forefront of transforming the pharmaceutical landscape in the Middle East. From localizing production in Saudi Arabia to pioneering collaborations with global institutions, the company is driving innovation in a rapidly evolving market. As Saudi Arabia’s Vision 2030 reshapes the future of…

Denmark Zealand Pharma’s transformational journey from a niche biotech to a commercial-stage player in the booming global obesity market has reached another major milestone. As part of a USD 5.3 billion partnership with pharma giant Roche, Zealand will receive a USD 1.65 billion upfront payment, with Roche set to deliver Zealand’s…

China 2024 was another groundbreaking year for Chinese medicine approvals. Writing in the March 2025 edition of DIA’s Global Forum magazine, Juan Valencia S. and Angel Shao of PharmCube explain how and why.   Driven by drugmakers’ growing interest in accessing the world’s second-largest pharmaceutical market, China has recently seen a…

Global As healthcare systems grapple with rising costs and the need for broader access to treatment, off-patent medicines have taken on increasing importance. With budgets under pressure and blockbuster drugs losing exclusivity, the generics market is on track to reach USD 600 billion by 2033, with these five players leading the…

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…

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…