Analytical Expertise Center of MOH, which considers the pharmaceutical sector to be one of the most strategic sectors in public health protection, monitors the quality, safety, and efficacy of medicines and medical devices officially imported into the country. In addition to granting import permits, they also inspect the conditions under which these medicines are produced on both local and foreign manufacturing facilities.
In this field, the quality, safety, and efficacy of medicines are ensured through the implementation of Good Manufacturing Practice (GMP) standards. In recent years, Azerbaijan has taken significant steps to align its pharmaceutical sector with these international requirements. One of these steps was the recent approval of the new GMP rules.
GMP rules ensure that medicines are produced with high quality and in a controlled manner. These rules cover production processes, infrastructure, equipment, personnel, laboratory testing, and documentation. The main goal of GMP is to deliver quality, safe, and effective medicines to the consumer – the patient.
The new GMP rules, which came into effect in April 2025, aim to eliminate existing gaps in the sector and accelerate the alignment with the requirements of the European Union and the World Health Organization. The main changes are as follows:
- Implementation of Real-Time Release Systems (RVBS) and Parametric Release – ensuring the quality of the product through continuous monitoring at all stages of production, not only through final testing.
- Strengthening the Risk-Based Approach – enterprises are required to proactively identify risks and take preventive measures.
- Increasing the Use of Electronic Documentation and Traceability – expanding the use of technological solutions to prevent counterfeiting and human errors.
- Emphasizing the Role of Quality Control Personnel (Qualified Person – QP) – their responsibilities will be more clearly defined.
Who Benefits from These Changes?
- For Manufacturers – processes that provide greater transparency and access to international markets.
- For Exporters – recognition of medicines in European and other high-demand markets, enhancing competitiveness.
- For Consumers – production of safer, higher-quality, and more reliable medicines.
The successful implementation of GMP rules is possible not only through regulatory documents but also through ongoing training, audits, and public-private sector cooperation. The new rules provide significant opportunities for Azerbaijan’s pharmaceutical industry to integrate with international standards, which will bring long-term benefits to both the national economy and public health.
