Building a modern regulatory framework for medical and industrial cannabis requires more than a comprehensive legal foundation. It also depends on the ability of public institutions to implement legislation effectively, consistently and in accordance with internationally recognised standards. Within this context, the support provided through the European Union’s Technical Assistance and Information Exchange (TAIEX) instrument marked an important milestone in strengthening the institutional capacity of the National Cannabis Control Agency and enhancing Albania’s regulatory capabilities for the implementation of Law No. 61/2023. 

As one of the European Commission’s principal instruments for technical cooperation, TAIEX facilitates the transfer of expertise, administrative knowledge and best regulatory practices between European Union Member States and partner countries. Through this initiative, the Agency gained direct access to European regulatory authorities, specialised institutions and internationally recognised experts, providing a unique opportunity to examine well-established governance models and modern approaches to the regulation of medical and industrial cannabis.

A central component of the project consisted of two high-level study visits to Portugal and Italy, designed to provide practical insight into the operation of mature European regulatory systems. These missions enabled the Albanian delegation to analyse the institutional organisation of competent authorities, licensing procedures, inspection methodologies, regulatory oversight mechanisms, traceability systems and quality assurance frameworks governing the cultivation, processing and distribution of medical cannabis. Particular attention was devoted to the implementation of internationally recognised Good Agricultural and Collection Practices (GACP), Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) throughout the entire production and supply chain. 

During the study programme in Portugal, representatives of the Agency engaged with key national and European institutions responsible for medicines, drug policy and public health. Meetings with INFARMED, ICAD and EUDA provided valuable insight into integrated regulatory governance, institutional coordination, early warning mechanisms, risk analysis and evidence-based policymaking. A site visit to a licensed medical cannabis operator further enabled participants to observe the practical implementation of GACP and GMP standards within commercial cultivation and processing facilities, illustrating how regulatory requirements are translated into operational practice. Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP) në proceset e kultivimit dhe përpunimit. 

The second study visit, organised in Italy, complemented this experience by presenting one of Europe’s most established institutional models for the regulation of medical cannabis. Meetings hosted by the Italian Ministry of Health, the Italian Medicines Agency (AIFA), the Central Narcotics Office and the Military Chemical Pharmaceutical Institute in Florence provided comprehensive insight into authorisation procedures, import and export control mechanisms, prescription monitoring systems, EU-GMP inspections and the management of a fully integrated pharmaceutical production chain. Of particular strategic importance was the opportunity to examine the clear separation of responsibilities between regulatory, licensing and inspection authorities, a governance principle reflected in the United Nations drug control conventions and recognised as an international best practice for ensuring transparency, accountability and regulatory integrity. 

The value of the project extended well beyond the technical knowledge acquired during the study visits. The exchange of expertise and direct engagement with European counterparts significantly strengthened the professional capacity of the Agency and participating Albanian institutions. The experience gained has informed the development of secondary legislation, administrative procedures, inspection methodologies and supervisory mechanisms, supporting the establishment of a more robust, transparent and effective regulatory framework for the sector.

Equally important was the creation of sustainable professional relationships with counterpart institutions across Europe. These connections provide a valuable platform for continued dialogue, future technical cooperation and participation in international regulatory networks, contributing to the continuous development of institutional knowledge and administrative excellence.

Within the broader context of Albania’s European integration process, the TAIEX project represents far more than a technical assistance initiative. It constitutes a strategic investment in institutional development and regulatory modernisation, strengthening the foundations of a governance model built upon scientific expertise, institutional integrity, international cooperation and the protection of the public interest.

Through this project, the National Cannabis Control Agency has further advanced its capacity to implement a transparent, accountable and European-standard regulatory system capable of responding to the challenges of a highly regulated sector while supporting the sustainable development of medical and industrial cannabis in full alignment with European Union principles and internationally recognised regulatory standards.