ANMDMR

What ANMDMR does

ANMDMR (Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România) is Romania's national regulatory authority for medicines and medical devices, operating as a public administrative institution under the Romanian Ministry of Health. The agency's mandate covers the authorization of human medicines, oversight of clinical trials, pharmacovigilance and adverse reaction monitoring, medical device registration including CE marking oversight, market surveillance, and supply chain integrity (serialization). It serves four primary constituencies: pharmaceutical companies seeking marketing authorization and pharmacovigilance compliance, medical device companies requiring registration and market surveillance, healthcare professionals reporting adverse reactions and accessing drug safety information, and patients and the general public accessing safety information and reporting adverse events.

The agency's core technology footprint consists of an interconnected portfolio of regulatory information management systems. These include the Nomenclatorul medicamentelor de uz uman (national medicine nomenclature database at nomenclator.anm.ro), the Baza Națională de Date a Dispozitivelor Medicale (national medical devices database at dispozitive.anm.ro), the Portal ANMDMR (portal2.anm.ro) for online regulatory submissions, a dedicated document upload platform, and covid19.anm.ro for COVID-19 vaccine adverse reaction reporting. EU-integrated systems include CTIS (Clinical Trials Information System) for pan-European clinical trial authorization across up to 30 EEA countries via a single application, EUDAMED for medical device registration, the UDI (Unique Device Identification) system, and the Serialization system for supply chain authenticity. These platforms collectively implement EU pharmaceutical and medical device regulations at the national level.

As a government state entity, ANMDMR does not operate a commercial revenue model. It is funded through Romanian state budget allocations and regulatory fees, with no external investment, no parent company, no subsidiaries, and no disclosed commercial revenue. The agency's value proposition rests on its statutory monopoly over national medicines and medical devices regulation, its integration with European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) networks, and its comprehensive national pharmacovigilance infrastructure. Its go-to-market is institutional rather than commercial: marketing channels are limited to its official website, social media presence (Facebook, LinkedIn, YouTube), press releases, and public awareness campaigns such as MedSafetyWeek, European Antibiotic Awareness Day, and the 'Medicines are not candies' initiative. Distribution is conducted via online regulatory portals, the CTIS system, direct administrative procedures, and public information services.

Name

ANMDMR

Legal name

Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România

Website

https://anm.ro

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

101–250 employees

Short description

ANMDMR is Romania's national regulatory authority for medicines and medical devices, operating under the Ministry of Health to authorize drugs, oversee clinical trials, monitor pharmacovigilance, and maintain national medical product databases serving pharma companies, device manufacturers, healthcare professionals, and the public.

Ownership category

akta.pro rank

Headquarters

HQ city

Bucharest

HQ country

Romania

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure

Distribution channels4 records

Marketing channels7 records

Core offering

ANMDMR is Romania's national regulatory authority for medicines and medical devices, operating under the Romanian Ministry of Health. It authorizes medicines for human use, monitors drug safety through pharmacovigilance, regulates clinical trials, oversees medical devices including CE marking and EUDAMED registration, and ensures compliance with EU pharmaceutical regulations. The agency maintains national nomenclature databases, operates online reporting platforms for adverse reactions, and processes parallel import authorizations and operating permits for economic operators.

Product overview

ANMDMR (Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România) is Romania's national regulatory agency for medicines and medical devices. The agency operates a portfolio of interconnected digital platforms and regulatory databases. The core offerings include the Nomenclatorul medicamentelor de uz uman (drug nomenclature database), the Baza Națională de Date a Dispozitivelor Medicale (national medical devices database), the Portal ANMDMR for regulatory submissions, the Sistemul de raportare online reacții adverse COVID-19 for COVID-19 vaccine adverse reaction reporting, and the Raportează o reacție adversă portal for general pharmacovigilence reporting. Additional systems include the Sistemul Informatic pentru Studii Clinice (CTIS) for clinical trial authorizations, Sistemul EUDAMED for medical device registration, Serializare for medicine supply chain authenticity, and the Sistemul UDI for unique device identification. These platforms collectively enable regulatory compliance with EU standards for medicines and medical devices.

Differentiator

Problem solved

Functional benefit

Products and services

• Marketing Authorization for Medicines Regulatory authorization service for pharmaceutical companies seeking market authorization for human medicines in Romania, including evaluation of quality, safety, and efficacy data.
• Clinical Trial Authorization via CTIS Regulatory service enabling clinical trial sponsors to apply for authorization in up to 30 EEA countries through a single application managed at national level by ANMDMR under EU Clinical Trials Regulation 536/2014.
• Pharmacovigilance and Adverse Reaction Reporting Online adverse reaction reporting system available to patients and healthcare professionals, supporting pharmacovigilance activities and safety signal evaluation.
• Medical Device Registration and CE Marking Oversight Regulatory service for medical device companies covering CE marking, market surveillance, incident reporting, and national database registration.
• Parallel Import Authorization Authorization service allowing pharmaceutical companies to import medicines that are already authorized in other EU member states into the Romanian market.
• Operating Permits for Economic Operators Verification and issuance system for operating permits required by economic operators active in Romania's pharmaceutical and medical devices sectors.
• National Medicine Nomenclature Database (Nomenclator) Public online database containing all registered human-use medicines authorized in Romania, available in searchable and downloadable XLSX formats for healthcare professionals and the general public.
• National Medical Devices Database Public online database allowing users to search for medical devices registered in Romania and download F1/F2 nomenclature in XLSX format.
• EUDAMED Registration Service Service supporting medical device manufacturers in registering devices in the European EUDAMED database, as required under EU medical device regulations.
• COVID-19 Adverse Reaction Reporting Platform Dedicated online platform for patients and healthcare professionals to report suspected adverse reactions to COVID-19 vaccines, with separate forms for each user type.

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• EMA (European Medicines Agency)coreTechnology or IntegrationANMDMR collaborates with EMA on pharmacovigilance activities, clinical trial authorization through CTIS, safety signal evaluation, and regulatory harmonization across the EU. The agency participates in PRAC procedures and implements EMA guidelines for Good Pharmacovigilance Practices.
• HMA (Heads of Medicines Agencies)coreStrategic or Co-development PartnerANMDMR participates in the HMA network of national medicines regulatory authorities across Europe, coordinating on harmonized regulatory approaches and joint initiatives such as the 'Medicines are not candies' campaign.
• INSP (Institutul Național de Sănătate Publică)coreStrategic or Co-development PartnerCollaboration protocol for adverse reaction data sharing, COVID-19 vaccination adverse event monitoring, and joint investigation of safety cases. Data is transmitted to INSP and Ministry of Health under collaboration agreement nr. 1304/30.01.2020.
• Ministry of Health (Romania)coreStrategic or Co-development PartnerNational health authority oversight with joint data sharing for public health monitoring, COVID-19 response coordination, and policy implementation.
• Colegiul Medicilor din România & Colegiul Farmaciștilor din RomâniaminorStrategic or Co-development PartnerFor awarding EMC and EFC (continuous medical/pharmacy education) credits to healthcare professionals who report adverse reactions through ANMDMR.
• Healthcare Professionals NetworkcoreStrategic or Co-development PartnerDoctors, pharmacists, dentists, nurses who report adverse reactions, participate in pharmacovigilance activities, and serve as first points of contact for patient medicine safety inquiries.
• ECDC (European Centre for Disease Prevention and Control)minorStrategic or Co-development PartnerCollaborates on European Antibiotic Awareness Day initiatives and antimicrobial resistance public health campaigns.

Recent moves6 records

Expansion highlights5 records

Direct peers

• Agenzia Italiana del Farmaco (AIFA): Italy's national medicines regulatory authority, performing the same functions as ANMDMR — marketing authorization, pharmacovigilance, clinical trial oversight, and medical device regulation — under the Italian Ministry of Health. Direct functional counterpart in a comparable EU member state.
• AEMPS (Agencia Española de Medicamentos y Productos Sanitarios): Spain's national medicines and medical devices regulatory agency. Performs equivalent functions to ANMDMR including CTIS participation, EUDAMED registration coordination, and national pharmacovigilance. Direct peer in EU regulatory network.
• Český ústav pro kontrolu léčiv (SÚKL): Czech Republic's State Institute for Drug Control — the national medicines regulatory authority. Performs equivalent functions to ANMDMR for medicines regulation, with comparable scale and Central European EU member state context.
• OGYÉI (Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet): Hungary's National Institute of Pharmacy and Nutrition, the national regulatory authority for medicines and medical devices. Closely comparable to ANMDMR in mandate, scale, and Central/Eastern European EU context.

Broad incumbents

• Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM): Germany's federal institute for medicines and medical devices, operating as a larger, more established peer within the same EU regulatory network. Comparable mandate on drug authorization and pharmacovigilance, with substantially greater scale and influence within EMA committees.
• Agence nationale de sécurité du médicament (ANSM): France's national agency for medicine and health product safety. Direct functional equivalent to ANMDMR for medicines and medical devices, with broader portfolio including cosmetics and tattoo products. Plays a leading role in EU pharmacovigilance procedures.
• European Medicines Agency (EMA): EU-level decentralized agency coordinating national regulatory authorities including ANMDMR. While not a direct competitor, EMA centralizes many functions (centralized marketing authorization, PRAC, scientific advice) that national agencies like ANMDMR support and implement.
• Medicines and Healthcare products Regulatory Agency (MHRA): UK's regulatory agency for medicines, medical devices, and blood components. Comparable in mandate to ANMDMR but at substantially greater scale, post-Brexit now operating as a third-country regulator while maintaining international cooperation agreements.

Others

• PRAC (Pharmacovigilance Risk Assessment Committee): EMA committee responsible for assessing pharmacovigilance data — ANMDMR's President and delegates participate in PRAC as Romania's representatives. Not a competitor, but the EU-level body that ANMDMR feeds data into and implements decisions from.
• EUDAMED (European Database on Medical Devices): EU-wide database for medical device registration, in which ANMDMR participates as the Romanian national authority. Operates as adjacent/integrated infrastructure that ANMDMR helps populate and oversee for the Romanian market.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights5 records

Customer concentration

• YouTubeyoutube.com/channel/UCgNJWxyl0_Ngu34y2Y0NFuA
• Facebookfacebook.com/anmdm.ro
• LinkedInlinkedin.com/company/anmdm

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about ANMDMR