Scientific Center of Drug and Medical Technologies Expertise

What Scientific Center of Drug and Medical Technologies Expertise does

The Scientific Center of Drug and Medical Technologies Expertise (SCDMTE), operating since April 25, 2024 as a State Non-Commercial Organization (SNPO) under the Ministry of Health of the Republic of Armenia, is the country's designated national regulatory authority for medicines, medical devices, and pharmaceutical products. The center succeeded the former Scientific Center of Drug and Medical Technology Expertise after academician E. Gabrielyan CJSC and is responsible for implementing Armenia's national drug policy, ensuring the availability of safe, effective, and quality drugs in the Armenian market. Its operational scope covers human and veterinary medicines registration under both national procedures and EAEU-aligned rules (Decisions N78, N87, N88), clinical trial authorization and safety monitoring, GMP/GDP compliance inspections and certification, borderline product classification, pharmacovigilance via the WHO VigiFlow system, and an advertising permission service launched in March 2025.

The center maintains a public Register of Medicinal Products database, a tripartite website (Armenian, Russian, English), and formal cooperation links with the WHO, U.S. FDA, European Medicines Agency (EMA), and ENCPP. It is headquartered at 49/5 Komitas Avenue, Yerevan (postal code 0051), and operates with a headcount in the 101-250 range. Under the leadership of Acting Director Arayik Baghryan, the organization publishes regulatory updates, ministerial orders, and government decrees on its website, including recent instruments such as Minister of Health Orders N322-N and N326-N (November 2024), Order N3273-A (May 2025), and Government Decree N1328-A (September 2025).

The center's revenue model is a hybrid of state budget funding and regulated service fees. The Government of the Republic of Armenia provides public non-commercial funding, while the center also collects state duties for regulatory services under the RA Law "On State Duty," which replaced former assessment fees. Disclosed unit pricing includes 20,000 AMD per product for borderline product classification examinations. Customer segments are vertically diversified across pharmaceutical companies, clinical research organizations, healthcare providers, medical device companies, and veterinary pharmaceutical firms, all of which are required by Armenian law to engage the center for market access, regulatory compliance, and post-market surveillance activities.

Name

Scientific Center of Drug and Medical Technologies Expertise

Legal name

Center of Drug and Medical Technologies Expertise SNPO (Center of Drug and Medical Technology Expertise SNPO)

Website

https://pharm.am

Company type

Private

Founded year

2024

Operating status

Operating

Headcount range

101–250 employees

Short description

The Scientific Center of Drug and Medical Technologies Expertise (SCDMTE) is Armenia's national regulatory authority for medicines and medical devices, operating as a State Non-Commercial Organization under the Ministry of Health. It provides registration, GMP/GDP certification, clinical trial authorization, pharmacovigilance, and borderline product classification services to pharmaceutical companies and healthcare providers across Armenia under EAEU-aligned frameworks.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Services

NAICS

Other Scientific and Technical Consulting Services (54169), Professional, Scientific, and Technical Services (54)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Engineering, Accounting, Research, Management (8700)

akta.pro primary industry

Drug Regulators (Human Pharmaceuticals) (HLAJADAA)

akta.pro secondary industries

Clinical Trials Authorization & Oversight (GCP) (HLAJADAF), Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH), Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA), Pharmacovigilance & Drug Safety Software (HLAGAJAK)

Keywords

• Pharmaceutical regulatory services
• Medicines registration
• Pharmacovigilance monitoring
• GMP compliance inspection
• Clinical trials authorization

Headquarters

HQ city

Yerevan

HQ country

Armenia

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Others

Revenue model

1. Regulatory Assessment Fees: Fees charged for various regulatory services including medicines registration, quality assessments, borderline product classification, and GMP/GDP inspections
2. State Budget Funding: Government-funded public non-commercial organization implementing national drug policy

Pricing tiers

Distribution channels2 records

Marketing channels4 records

Core offering

The Scientific Center of Drug and Medical Technologies Expertise (SCDMTE) is Armenia's national regulatory authority for medicines and medical devices, operating as a State Non-Commercial Organization under the Ministry of Health. It provides regulatory expertise services including state registration and re-registration of medicinal products, pharmacovigilance and adverse drug reaction monitoring, GMP/GDP compliance inspections and certification, clinical trial authorization and safety oversight, borderline product classification, and advertising permission assessments, in accordance with Armenian national legislation and EAEU regulatory frameworks.

Product overview

The Scientific Center of Drug and Medical Technologies Expertise (SCDMTE) is Armenia's national regulatory authority for medicines and medical technologies. The center provides a portfolio of regulatory services rather than a traditional product suite, including: the Register of Medicinal Products database for public verification of registered medicines, medicines registration and assessment services under national and EAEU procedures, clinical trial authorization and safety monitoring, GMP/GDP compliance inspections, pharmacovigilance services for adverse reaction reporting, and borderline products classification. The center operates primarily as a government regulatory body under the Armenian Ministry of Health, with the website serving as the public-facing interface for these services.

Differentiator

Problem solved

Functional benefit

Products and services

• Register of Medicinal Products Database

Segments5 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Five partnerships are on record, tiered minor and core.

• U.S. Food and Drug Administration (FDA)minorOthersInternational regulatory cooperation through FDA banner link on official website, indicating alignment with international regulatory standards and information exchange.
• World Health Organization (WHO)coreOthersActive partnership with WHO for drug safety monitoring. The center uses WHO's VigiFlow system for adverse drug reaction reporting (https://vigiflow-eforms.who-umc.org/am/adr) and maintains banner link indicating ongoing cooperation.
• European Medicines Agency (EMA)minorOthersInternational regulatory cooperation through EMA banner link on official website, indicating alignment with European regulatory standards.
• European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCPP)minorOthersInternational cooperation for pharmacovigilance activities, with banner link on official website.
• Eurasian Economic Union (EAEU)coreStrategic or Co-development PartnerCore regulatory framework partner. The center implements EAEU rules for medicines registration and assessments, including Decision N78 on rules for medicines registration, Decision N88 on medication guide requirements, and EAEU GMP/GDP guidelines. Coordinates with EAEU Council of the Eurasian Economic Commission.

Scale indicators2 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• Roszdravnadzor: Russian federal service for surveillance in healthcare, serving as Russia's national drug and medical device regulator. Directly comparable to SCDMTE as a state regulatory authority operating under EAEU rules for medicines registration and pharmacovigilance in a post-Soviet jurisdiction.
• Medicines and Medical Devices Agency of Serbia (ALIMS): Serbian national medicines and medical devices agency with comparable mandate covering registration, pharmacovigilance, and GMP oversight. Peer to SCDMTE as a similarly-sized national regulator in a neighboring region.
• Republican Center for Expertise and Testing in Health Care (Belarus): Belarusian national center responsible for expertise and testing of medicines and medical products, also operating under EAEU rules. Direct peer given shared regulatory function and EAEU coordination with Armenia's SCDMTE.
• National Center for Expertise of Medicines and Medical Devices (Kazakhstan): Kazakhstan's national center for medicines and medical devices expertise, also operating as a national drug regulator under EAEU framework. Directly comparable to SCDMTE in mandate, EAEU alignment, and post-Soviet regulatory structure.
• Turkish Medicines and Medical Devices Agency (TITCK): Turkey's national regulatory authority for medicines and medical devices, performing registration, GMP inspections, pharmacovigilance, and clinical trial oversight. Comparable to SCDMTE in functional scope and emerging-market regulatory complexity.
• State Expert Center of the Ministry of Health of Ukraine: Ukrainian state expert center handling drug registration, pharmacovigilance, and clinical trial authorization. Comparable peer given similar scope of national regulatory expertise functions.

Regional players

• Georgia's Regulation Agency for Medical and Pharmaceutical Activities: Georgian national regulator for medicines and pharmaceutical activities. Regional peer operating in the Caucasus with similar national regulatory scope but in a different jurisdiction.

Broad incumbents

• European Medicines Agency (EMA): EU-wide medicines regulatory body providing framework standards that SCDMTE references and aligns with. Comparable in regulatory mandate scope but operates across EU member states rather than as a national authority.
• U.S. Food and Drug Administration (FDA): U.S. federal regulatory authority for drugs, medical devices, and food. Peer to SCDMTE in regulatory function and mandate scope, though vastly larger scale and global standard-setter role.

Others

• WHO Uppsala Monitoring Centre: World Health Organization collaborating centre that operates VigiFlow, the pharmacovigilance reporting system SCDMTE is integrated with. Ecosystem peer given the operational integration and international standards alignment.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/scdmte
• Facebookfacebook.com/ScientificCentreOfDrugExpertise

Compliance5 records

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 Scientific Center of Drug and Medical Technologies Expertise