Pharma and medical devices

Russia: Adopted Regulation on issuing clinical trial permits

As of 21 April 2018, developers of pharmaceuticals (the Applicants) are required to follow the adopted procedure if they wish to obtain a permit for a clinical trial for their pharmaceuticals.

The state agency responsible for issuing clinical trial permits is the Ministry of Healthcare of the Russian Federation.

EAEU: Adopted unified Guideline for the quality of modified-release drugs

The adopted Guideline has been approved for the use by the authorized bodies of the EAEU member states.

 The Guideline applies to dosage forms in which the modification of the rate and (or) the place of release of the active ingredient (active substances) in a definite manner is compared with the standard release dosage forms.

Ukraine: Amended drug registration procedure

As of 24 November 2017, manufacturers and importers of pharmaceuticals (drugs) are required to comply with the revised drug registration requirements.

The amendments to the drug (pharmaceutical/medicine) registration procedure have been introduced by Order No. 1202 of 2 October 2017.

Russia: Medical device technical documentation. Compulsory information to be provided by the manufacturer

Manufacturers and importers of medical devices that submit a registration application for these devices after 24 March 2017, have to ensure that their technical documentation contains all required information, as prescribed by the adopted Order No. 11n dated 19 January 2017. This technical documentation is to be submitted as a part of a registration dossier for any medical devices.