Agence Nationale des Produits Pharmaceutiques

Name

Agence Nationale des Produits Pharmaceutiques

Legal name

Agence Nationale des Produits Pharmaceutiques

Website

https://anpp.dz

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

101–250 employees

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Services

akta.pro primary industry

Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI)

akta.pro secondary industries

Health, Pharmaceuticals & Medical Devices Regulatory Cooperation (BPADANAJ), Clinical Development & Regulatory for Vaccines (trials, pharmacovigilance, lot release) (HLAAAEAK), Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH)

Keywords

• Pharmaceutical regulation
• Drug registration services
• Medical device homologation
• Pharmaceutical quality control
• Regulatory inspection services

Headquarters

HQ city

Algiers (Alger)

HQ country

Algeria

HQ region

Africa

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Government Budget Funding: As a public institution under the supervision of the Ministry of Pharmaceutical Industry, ANPP is funded through government budget allocations rather than revenue generation

Go-to-market motion1 record

Distribution channels5 records

Marketing channels4 records

Core offering

ANPP is Algeria's national regulatory authority for pharmaceutical products and medical devices, delivering pharmaceutical product registration, medical device homologation, quality control testing, pharmacovigilance, and inspection of pharmaceutical establishments. The agency operates a 1,200 m² central quality control laboratory, manages the E-TASJIL digital registration platform, and provides services through its Algiers headquarters plus Oran and Constantine regional annexes to pharmaceutical manufacturers, medical device companies, vaccine producers, and concession pharmacists.

Product overview

ANPP operates as a regulatory agency offering a portfolio of core regulatory services (pharmaceutical product registration, medical device approval, quality control, regulatory vigilance) delivered through digital platforms (E-TASJIL, RDV PP, RDV DM, RCP, PP Illicites) and physical laboratory infrastructure (Central Laboratory and regional annexes in Oran and Constantine). The E-TASJIL platform handles digital registration management while appointment scheduling platforms manage file submissions for pharmaceutical products and medical devices.

Differentiator

Problem solved

Functional benefit

Products and services

• E-TASJIL Online platform that allows pharmaceutical operators to submit, manage, and track registration applications for pharmaceutical products in Algeria.
• RDV PP (Rendez-vous Produits Pharmaceutiques) Online appointment scheduling platform for submitting pharmaceutical product files to ANPP, open every Wednesday from 10:00 through Thursday 10:00.
• RDV DM (Rendez-vous Dispositifs Médicaux) Online appointment scheduling platform for medical device submissions to ANPP, open every Tuesday from 10:00 through Thursday 10:00.
• Etat Déclaratif Declarative statement online platform for pharmaceutical regulatory compliance submissions.
• RCP (Résumé des Caractéristiques du Produit) Public portal providing access to the Summary of Product Characteristics for pharmaceutical products registered in Algeria.
• PP Illicites Online reporting platform for cases of illicit marketing of pharmaceutical products.
• Pharmaceutical Product Registration Statutory registration and approval service for pharmaceutical products ensuring quality, efficacy, and safety of medications before commercial release in Algeria, performed for pharmaceutical manufacturers and importers.
• Medical Device Homologation Homologation and certification service for medical devices ensuring compliance with Algerian regulatory requirements before market placement, performed for device manufacturers and importers.
• Quality Control and Expertise Laboratory testing and quality control services for pharmaceutical products, medical devices, and vaccines, delivered through ANPP's central laboratory and the pharmacology and toxicology laboratory in Constantine.
• Regulatory Vigilance and Inspection Post-market surveillance, pharmacovigilance activities, and inspection of pharmaceutical establishments performed by ANPP across Algeria.
• Advertising Visa Authorization service that issues a visa allowing pharmaceutical product advertising in Algeria.
• Pharmacology and Toxicology Laboratory (Constantine) Animal-testing facility used by ANPP to perform pharmacology and toxicology control of injectable medicines, biotechnological products, and vaccines, operated as part of the Constantine regional annex.

Quantifiable outcome

• 70% of pharmaceutical products manufactured locally, reducing import dependency
• +2 more outcomes

Named customers3 records

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

Ten partnerships are on record, tiered core and major.

• State Institute of Medicines and Good Practices (Russia)coreStrategic or Co-development Partner · 28 June 2026MoU signed between ANPP and Russia's Federal State Institution 'State Institute of Medicines and Good Practices' under Russian Ministry of Industry and Trade. Aims to strengthen cooperation through expertise exchange and establish mutual recognition mechanisms, particularly in inspection and GMP.
• Egyptian Drug Authority (EDA)coreStrategic or Co-development Partner · 15 June 2026MoU signed between ANPP and Egyptian Drug Authority during Africa Health ExCon 2026 to strengthen and develop scientific and technological cooperation in pharmaceuticals and medical devices. Includes mutual technical support to strengthen regulatory and oversight capacities and promote mutual recognition.
• Saidal Group (Public Pharmaceutical Complex)coreStrategic or Co-development Partner · 2 March 2026MoU signed between ANPP and Saidal Group to coordinate efforts and jointly leverage capacities, expertise, and material and human resources for developing scientific research and innovation in pharmaceutical industry. Includes collaboration on drug efficacy and toxicity laboratory using animal models.
• Research Centers (CRBT, CRSP, Pharmacy Departments)majorStrategic or Co-development Partner · 14 December 2024Framework conventions signed with Biotechnology Research Center (CRBT), Pharmaceutical Sciences Research Center (CRSP), and pharmacy departments of medical faculties in Constantine, Annaba, Batna, and Sétif. Aims to create a biotechnology hub through mutualization of human and material resources.
• Algerian Universities (Pharmacy and Medical Faculties)majorStrategic or Co-development Partner · 11 December 2023Partnership conventions signed between ANPP and various faculties including Faculty of Pharmacy Algiers, Faculty of Medicine Oran, Faculty of Medicine Tlemcen, and others. Provides internship opportunities for pharmacy students and promotes scientific research collaboration.
• ANMAT (Argentine National Administration)majorStrategic or Co-development Partner · 5 June 2023Meeting between ANPP and Argentina's National Administration of Medicines, Food and Medical Technology to discuss cooperation axes including pharmaceutical product registration and medical device homologation.
• World Health Organization (WHO)coreStrategic or Co-development Partner · 2 May 2023ANPP participates in WHO-organized workshops on vaccine production, including the workshop on 'Setting up local and sustainable production of quality vaccines in Africa'. WHO is also supporting ANPP's journey toward Maturity Level 3 (ML3) certification.
• CECMED (Cuban Regulatory Authority)majorStrategic or Co-development Partner · 13 February 2023Cooperation between ANPP and Cuba's Center for State Control of Medicines, Equipment and Medical Devices. Implementation of 2021 convention, information exchange, and action plan for 2023 including joint work on pharmaceutical regulation.
• Jordanian Food and Drug Administration (JFDA)majorStrategic or Co-development Partner · 18 December 2022Coordination meeting between ANPP and JFDA for exchange of experiences in technical evaluation and control of pharmaceuticals and medical devices. Development of cooperation projects in pharmaceutical product registration including generic drug registration.
• United Nations Development Programme (UNDP)coreStrategic or Co-development Partner · 29 September 2022Ongoing cooperation between ANPP and UNDP for technical and capacity building support. UNDP is implementing the project 'Support to the Health and Pharmaceutical Industry Sectors in the Fight against Covid-19' funded by the German government. The collaboration includes strengthening capacities for vaccine production and control of innovative biotech products.

Scale indicators6 records

Recent moves8 records

Expansion highlights6 records

Others

• World Health Organization (WHO): Not a regulator per se, but a key ecosystem player — supporting ANPP's ML3 journey, vaccine production workshops, and GDP training that directly enable regulatory capacity-building.

Direct peers

• State Institute of Medicines and Good Practices (Russia): Russian federal institution under the Ministry of Industry and Trade; signed a June 2026 MoU with ANPP to establish mutual recognition, particularly in inspection and GMP.
• ANMAT (Argentina): Argentina's national regulator for medicines, food, and medical technology; engaged with ANPP on registration and medical device homologation cooperation axes.
• Egyptian Drug Authority (EDA): Egypt's national pharmaceutical regulator covering drug registration, medical device approval, and quality control; signed an MoU with ANPP in June 2026 to strengthen scientific and technological cooperation, including mutual recognition.
• Jordanian Food and Drug Administration (JFDA): Jordan's medicines and medical devices regulator; has an active cooperation framework with ANPP focused on technical evaluation, control of pharmaceuticals, and generic drug registration.
• CECMED (Cuba): Cuban center for state control of medicines, equipment and medical devices; has a 2021 convention and ongoing 2023 action plan with ANPP for information exchange and joint regulatory work.

Broad incumbents

• U.S. Food and Drug Administration (FDA): Global gold-standard pharmaceutical regulator; relevant as the mature incumbent whose framework (including GMP standards) shapes the regulatory environment ANPP is converging toward via ML3.
• European Medicines Agency (EMA): EU-wide medicines regulator; reference point for the GMP and ICH standards that ANPP is aligning with through WHO and bilateral partnerships.

Regional players

• Morocco – Direction du Médicament et de la Pharmacie (DMP): Morocco's national pharmaceutical regulator; comparable Maghreb-region counterpart whose regulatory decisions affect cross-border pharma flows relevant to ANPP's market.
• Tunisia – Direction de la Pharmacie et du Médicament (DPM): Tunisia's pharmaceutical regulatory authority; another Maghreb regional peer with overlapping mandate over drug registration and pharmacovigilance.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/ANPP.AGENCE
• LinkedInlinkedin.com/company/agence-nationale-des-produits-pharmaceutiques

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries3 records

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 Agence Nationale des Produits Pharmaceutiques