Regulatory

Russia Updates Pharma Licensing: New Timelines and Remote Inspections

The Russian Government has approved a new resolution updating the procedure for licensing pharmaceutical manufacturing. The document, prepared by the Ministry of Industry and...

Experts propose changes to the rules for regulating veterinary medicinal products in the EAEU

On February 25, a working meeting of experts was held at the Russian Union of Industrialists and Entrepreneurs (RSPP) to develop proposals for amending...
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Recommendations on registering medical devices in EAEU adopted

On December 23, the Eurasian Economic Commission's Board meeting adopted the Methodological Recommendations on the content and structure of...

The EEC Collegium approved amendments to the rules for determining OTC categories of medicines

According to the source, the general criteria for classifying drugs as OTC have been supplemented with special criteria for individual active substances.

Rules of import and export of biomaterials produced during clinical trials of drugs become effective in Russia

Rules of import and export of biomaterials produced during clinical trials of drugs become effective in Russia from September...

FDA approves Sanofi’s Dupixent for widespread use in the United States

Sanofi won expanded U.S. approval for its best-selling Dupixent injection to treat an allergic inflammation of the esophagus, the...

U.S.FDA lifts ban on COVAXIN Covid-19 vaccine candidate study

Ocugen, Inc., a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals, and vaccines, May 23th...

MicroGEM’s PCR test, which gives results in 27 minutes, received EUA approval from FDA

MicroGEM has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the MicroGEM...