Tagged with P

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…

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 is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? In order to be placed on the Romanian market, a medicinal product needs a marketing authorization, which can be issued by NAMMD at local level (under the national…

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…