Registration Processes for Pharmaceuticals Streamlined in the EAEU Market

On June 21, updated Rules for the Registration and Examination of Medicinal Products, approved by the Eurasian Economic Commission (EEC) Council, will come into force in the countries of the Eurasian Economic Union. The innovations are designed to speed up public access to medicines and reduce the administrative burden on manufacturers.

As emphasized by Valentin Tatarytsky, Minister of Technical Regulation of the EEC, the changes will be “an important step towards completing the transition to a single market for medicines” and will balance the interests of the pharmaceutical industry and patients.

“We strive to minimize barriers while maintaining high standards of quality and safety of medicines,” he said.

The new provisions affect the harmonization of registration procedures in the Union states and include the updating of registration dossiers in accordance with EAEU requirements. The reform also optimizes pharmaceutical inspections carried out on the initiative of the registration process.

One of the key innovations is the removal of restrictions on the parallel conduct of mutual recognition procedures and amendments to dossiers. According to the EEC, this will speed up the adaptation of national systems to the single market and ensure more sustainable access for patients to essential medicines.

The changes are part of a large-scale strategy to create a single pharmaceutical space in the EAEU.