Introduction
The Medicines and Medical Devices Agency of the Republic of Moldova announced that the government has approved new Good Manufacturing Practice (GMP) rules aimed at improving the quality and safety of medicines on the market.
New GMP Rules for Medicines
The newly approved regulations establish a clear framework for organizing and conducting manufacturing and import activities for human medicinal products, including those used in clinical investigations.
These rules are designed to strengthen quality control mechanisms for medicines manufactured and imported into the Republic of Moldova.
Simplified Regulatory Requirements
An important change introduced by the new regulations is the reduction in the number of required authorization documents for economic operators.
Previously, four documents were required. Under the new framework, only two are needed:
- Manufacturing and import authorization issued by the Agency for Medicines and Medical Devices (AMDM)
- GMP compliance certificate obtained through inspections confirming adherence to quality and safety standards
Clear Procedures and Responsibilities
The regulation also defines procedures related to authorization, inspection, and certification, as well as the responsibilities of manufacturers and importers involved in the production of medicines.
Impact on Medicine Quality and Safety
According to the agency, the implementation of these rules will contribute to:
- Increased safety and quality of medicines on the market
- Simplified procedures for operators
- More effective control by authorities
Supporting Quality and Compliance Systems
Structured regulatory frameworks and quality systems play a key role in ensuring compliance with international standards in pharmaceutical manufacturing and distribution. Discover the full range of quality and compliance services offered by Baupharma here: https://www.baupharma.com/services-categories/regulatory-affairs/#Regulatory-affairs-services
Conclusion
The approval of updated GMP rules represents an important step toward strengthening regulatory control and ensuring higher-quality medicines in the Republic of Moldova. By simplifying procedures and reinforcing quality standards, the initiative supports both industry efficiency and public health protection.
For more information: Better quality medicines on the market in the Republic of Moldova
