EEC has approved the quality guidance for modified-release drugs

| By | Drug Quality Control, EEC

At its meeting held on January 16, the Board of Eurasian Economic Commission (EEC) adopted a number of decisions in the area of technical regulation and customs administration. In particular, it approved the Quality Guidance for oral modified-release drugs.

The document has been elaborated with a view of harmonizing the requirements for confirming the quality of drugs while introducing changes to the registration dossier and evaluation of product equivalence.

The EEC Board recommended to the member states of the Union to use the document in the planning and studies on pharmaceutical development of medicinal products with prolonged and delayed release based on the principle of gastroresistance.

The guidance will allow to manufacture the medicines with stable pre-set parameters of quality and minimize the time and financial costs of manufacturers during the changes to the composition of previously developed dosage forms.

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