In 2017-2018, 67 additional documents will be prepared for the regulation of the market of medicines in the EAEU countries
The EEC continues to work on the creation of comfortable conditions for the pharmaceutical business in the EAEU countries. In 2017-2018, 67 additional documents will be prepared for the regulation of the common market of medicines. This was stated by the EEC Board Member - Minister in charge of technical regulation Valery Koreshkov at the opening the EAEU session in the framework of the Pharmaceutical forum of the Commonwealth of Independent States.
Speaking with the report on the regulation of the common market of medicines, the EEC Minister drew attention of the forum participants to the fact that the profile working group of the Commission finalized a number of draft documents of the so-called third level. These include requirements for water used for pharmaceutical production, guideline for validation of production processes, requirements for quality indicators for modified forms of medicines and some others.
For example, the requirements for water contains instructions for pharmaceutical production regarding various categories of water in the production of pharmaceutical substances, medicines for medical use and veterinary medicines. Water is one of the main products used in the pharmaceutical industry. It may be present as an auxiliary substance or used for preparation of medicines for use, for the production of finished goods, as a cleansing agent containers, etc. Depending on the pharmaceutical application, different categories of water may be needed: drinking, purified, highly purified, for injection, etc.
The EEC is now working on eleven new draft regulations in this area. They will ensure high quality of medicines, which is necessary for pharmaceutical products of the EAEU States on international markets.
Valery Koreshkov stressed that openness during the development of the documents to regulate the common market for medicines is an important principle in the activities of the Commission and the working group. All the regulations undergo extensive public discussion on the information portal of the Union.
The Chairman of the Pharmacopoeia Committee of the EAEU Elena Sakanyan announced publication of the first volume of the Pharmacopoeia of the Union in 2018, which will be a single set of requirements for the quality of medicines. This will ensure the unity of quality control of medicines in the Union.
Representatives of authorized bodies of Armenia, Kazakhstan and Kyrgyzstan said that they will complete alignment of the national legislation of their countries in accordance with the requirements of the EAEU in this area by April this year.
Press-release at the official Eurasian Economic Commission web-site