Romania

Regulatory

The regulatory process for clinical trials approval in Romania is transparent and relatively fast. The Clinical Trials Regulation aims to inform the public about all assessed applications for clinical trials and all trials being conducted in the EU. National Agency for Medicines and Medical Devices (NAMMD) in Romania grants clinical trial authorization to the sponsor or to the CRO acting on behalf of the sponsor. National Ethics Commission serves as the IRB arm for approval of clinical trials.

Official links
www.anm.ro
www.ms.ro

Pharmaceutical Industry & Clinical Trials Market

Over the years, the pharmaceutical industry in Romania has grown significantly, with average revenue of 8.3 billion RON (EUR 1.6 billion) annually. In early 2020, the value of Romania’s pharmaceutical market rose to EUR 4.46 billion, which accounts for prescription medicines (EUR 3.35 billion) and drugs sold over the counter (EUR 1.1 billion).

The manufacture, distribution, and regulation of pharmaceutical products are controlled by the National Agency for medicine and medical devices. The pharmaceutical companies in Romania comply with the rules of Good Manufacturing Practice (GMP) for the production and distribution of medicines.

Some advantages of conducting clinical trials in Romania are the availability of patients, clarity of regulatory processes, interested and qualified investigators, and sound infrastructure at a reasonable cost. Additional benefits include lower start-up costs and excellent access to specialists due to the collaboration between universities, opinion leaders, research sites and medical associations.

Medical System in Romania

In Romania, private and public medical service providers operate in tandem. Although Romania has a universal health coverage system, not all health care services are covered and there are additional out-of-pocket costs for certain treatments and prescriptions.

Romania has a highly centralized Social Health Insurance (SHI) system. The Ministry of Health (MOH) is primarily responsible for healthcare governance, while the National Health Insurance House (NHIH) regulates the system. The NHIH manages the social health insurance system and has extensive powers in relation to the reimbursement for medicinal products and medical services provided under the national health insurance system and via the national health programs.