The Eurasian Economic Commission (EEC) continues its work on establishing favorable environment for pharmaceutical businesses in the member states of the Eurasian Economic Union (EAEU). 67 additional documents to regulate the common market of drugs will be prepared in 2017-2018. This was announced by Valery Koreshkov, EEC Member of the Board (Minister) for Technical Regulation.
The specialized working group of the Commission finalized the drafts for a number of so-called “third level” documents. These include the requirements for the water used in pharmaceutical manufacture, guidance on validation of manufacture processes, requirements for the quality of modified dosage forms and some other documents.
Currently, EEC is working on eleven drafts of new regulations in this area. They will allow to ensure the high quality of medicinal products, as required for the entry of pharmaceutical products manufactured in the member states of the Union to the international markets.
Elena Sakanyan, the Chair of EAEU Pharmacopoeia Committee, announced the release of the first volume of the Union Pharmacopoeia, a single set of requirements for the quality of drugs, by 2018. This will allow to ensure the unified quality control of medicinal products manufactured in the Union.