Industry news

• EMA issues guidance for global development of antimicrobial medicines

  30 May 2022 Sarah Wills / European Pharmaceutical Review

  The European Medicines Agency (EMA) has published its final guideline on the evaluation of human medicines for the treatment of bacterial infections to help support the development of new antimicrobial medicines.

• IT solution for drug candidate’s efficacy verification

  27 May 2022 Marchmont Innovation News

  Special software has been developed at the South Urals State University (SUSU) in the city of Chelyabinsk. It helps determine if a drug candidate does really hit (and positively impact) a target in human cells to be treated. Pharmaceutical companies may “soon” expect to get access to the new product.

• Production of Enoxaparin sodium, a pharmaceutical substance, can be launched in Stary Oskol

  27 May 2022 GxPnews

  Andrey Chesnokov, the head of the administration of the Starooskolsky municipal district, held a working meeting with the management of OOO Amegen and representatives of resource-supplying organizations on the implementation of the investment project called “Production of Enoxaparin sodium (pharmaceutical substance)”. This was reported in the press service of Stary Oskol administration.

• The Eurasian Economic Union has specified its pharmacovigilance processes

  26 May 2022 GxPnews

  The Council of the Eurasian Economic Commission (EEC) has approved a new edition of the Rules of good pharmacovigilance practice (GVP) of the Eurasian Economic Union (EAEU). This is reported on the official website of the EEC.

• The Ministry of Health of Russia announced that most of the vaccines have been procured

  25 May 2022 GxPnews

  According to the press service of Russia’s Ministry of Health, most of the vaccines required to support the national calendar of preventive vaccinations have already been purchased this year.

• The Ministry of Health is confident in the safety of drugs approved for accelerated registration

  25 May 2022 GxPnews

  The approach to medicines registration in Russia, including emergency authorization, allows us to guarantee their effectiveness and safety, TASS reports with reference to the press service of the Ministry of Health of Russia.

• The Cabinet of Ministers is going to compensate the cost of pharmaceutical products transportation

  24 May 2022 GxPnews

  The Ministry of Industry and Trade of the Russian Federation has submitted for public discussion a draft decree of the Government of the Russian Federation on the rules for providing state support to domestic industrial organizations, including pharmaceutical, in order to compensate for product transportation costs. 

• The Eurasian Economic Union has specified its pharmacovigilance processes

  24 May 2022 GxPnews

  The Council of the Eurasian Economic Commission (EEC) has approved a new edition of the Rules of good pharmacovigilance practice (GVP) of the Eurasian Economic Union (EAEU). This is reported on the official website of the EEC.

• Russia has eliminated the shortage of therapies for epilepsy and thyroid diseases

  23 May 2022 GxPnews

  Russia’s problem with the shortage of medicines for epilepsy and thyroid diseases has been solved. This was reported in the press service of the Ministry of Health of the Russian Federation.

• FDA Publishes Draft Guidance on Quality Assessments

  23 May 2022 BioPharm International

  The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs, BLAs, or supplements.