Moldova approves stricter quality rules for medicines
The Government has revised the regulations for drug manufacturing to ensure that the domestic market has access to safer products. During a meeting on March 18, the Government approved the rules for Good Manufacturing Practice (GMP) for drugs.
The project aims to establish a unified regulatory framework for the application of good manufacturing practices (GMP) for human medicines, fully aligned with European Union standards and directives.
Additionally, the initiative seeks to eliminate administrative barriers and redundant processes by harmonizing the procedures for the authorization, certification, and supervision of manufacturers and importers.
A key new element is the implementation of a risk-based inspection system designed to optimize resource use and enhance predictability for economic operators.
"The proposed project establishes a clear and up-to-date regulatory framework that will enable the efficient application of the law and strengthen the quality control system for medicines manufactured and imported in the Republic of Moldova," declared Minister of Health Emil Ceban during the Government meeting.
One significant change directly impacts economic operators. Previously, four permits were required for their operations; now, only two will be necessary: the manufacturing and import authorization, issued by the Agency for Medicines and Medical Devices, and a certificate of compliance with GMP standards, which will be granted following inspections that confirm adherence to quality and safety standards.
These new amendments facilitate the coherent implementation of national legislation regarding medicines, promote convergence with the European Union acquis, enhance the efficiency of authorization and supervision mechanisms, and bolster the state's capacity to ensure the quality and safety of medicines, ultimately protecting public health.
