EEC continues to improve EAEU common market of medicines

| By | Drug Registration, EAEU, Plant-Based Drugs

The meeting of the Board of the Eurasian Economic Commission (EEC) has adopted several decisions aimed at improving the EAEU common market of medicines.

In particular, the approved Requirements for Stability Studies of Medicines and Pharmaceutical Substances will be used by the manufacturers in relevant studies. The document is necessary in order to establish the shelf life and storage conditions for pharmaceutical substances and medicinal products that have a specific composition, dosage form and packaging. This will allow to eliminate repeated stability studies and ensure the recognition of their results by the authorities of EAEU member states during the registration of medicines.

The Board of the Commission approved the passport and procedure for maintaining the reference book of international nonproprietary names. The decision provides for its inclusion in the EAEU unified regulatory and reference information system.

The adopted Quality Manual for Herbal Medicinal Products provides recommendations on preparing the specifications for herbal medicines and describing qualitative and quantitative characteristics of their active substances. The document also describes the quality control system for herbal medicinal raw materials and herbal pharmaceutical substances, vitamins and minerals, which can be additionally introduced into the herbal medicines, as well as for excipients. This Manual will help EAEU member states to establish common approaches to the preparation of regulatory documents on the quality and quality control of herbal medicinal products and create for them an effective quality assurance system.

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