SAS IDMP Identification of Medicinal Products

2017

Regulatory requirements of the regulator

The pharmaceutical industry is one of the most regulated in the world. The companies need to be guided in numerous global, regional and industry regulations, to observe requirements of control supervisory authorities and standards which cover a vital and operating cycle of development of medicines. One of them, ISO IDMP, (EMA) – Identification of Medicinal Products – represents the series consisting of 5 ISO standards which create a basis for the system of unique world identification of medicines.

It is expected that all pharmaceutical, biotechnology or medical companies working in the European Economic Area will shortly submit to regulations of the IDMP standards. Other regulating authorities, such as Food and Drug Administration of the USA and Agency on pharmaceutical medicines and medical devices of Japan, will also apply these standards in the regional legislation.

Observance of requirements – a difficult task for many companies. So, a part of problems arises because data are in the separate systems or that the quality of the provided documentation leaves much to be desired because of incompleteness of information.

SAS IDMP

To help the organizations with observance of these regulatory requirements, the SAS company developed the solution SAS IDMP which will help the pharmaceutical and biotechnology companies to bring the data into accord with ISO IDMP and other international standards and requirements of regulators.

SAS IDMP submits the complete platform where all necessary tools for visualization and preparation of the reporting enter. Its advantages are the built-in tools on integration and data scrubbing. The solution SAS Contextual Analysis using which labor-intensive processes, for example, extraction of necessary information from unstructured documents and natural languag processing, are executed automatically also is a part of the platform.

Use of the solution of SAS by the Russian producers of medicines will allow them to become more competitive in international market due to observance of requirements of standards. At the same time compliance to regulations gives advantage not only to the companies, but also patients. At the state level it will allow to buy the drugs working and recognized effective, at the level of medical institutions – will help doctors not to be confused with variety of medicines and their analogs and to appoint to patients really necessary drugs.