The Ministry of Health has presented a new procedure for the development of general pharmacopoeial articles (GPA) and pharmacopoeial articles, as well as the procedures for their inclusion in the state pharmacopoeia and their placement on the official website of the Ministry. The new document is expected to replace the procedure for the development of GPA approved by the order of the Ministry of Health of Russia № 756 of 26.08.2010.
The new procedure stipulates that the development of GPA should take into account the EEU pharmacopoeia. In addition to market participants, scientific organizations and specialized universities will be able to make proposals for the content of the GPA.

In addition, it is proposed to exclude the peculiarities of development of common pharmacopoeial articles for reference medicines during the period of validity of the patent for them, which imply obtaining the developer’s consent for inclusion of the GPA in the pharmacopoeia. The requirements to the content of the developed GPA will also be excluded.