Romania

Regulatory

Under Regulation (EU) No 536/2014, clinical trials in the EU are authorized through the Clinical Trials Information System (CTIS). A sponsor submits one harmonized application via the EU-portal for all intended Member States. The dossier is split into:

• Part I (scientific and technical documentation, common to all CMS)
• Part II (national documents, including ethics requirements)

One Reporting Member State (RMS) coordinates the scientific review, which must be completed within 45 days, with parallel national (Part II) reviews. Requests for information may pause the clock. Each Member State must then issue a decision within 5 days, leading to an overall maximum of 60 days (extensions possible for complex therapies).

The CTR harmonizes approvals across the EU, integrates ethics committees into the process, and ensures transparency through the EU trial database. Since 31 January 2023, all new trials in the EU must follow this system.

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.