Tag: Drug Registration

EEC announces the start of drug registration under unified EAEU rules

The first applications have been submitted for registration of medicinal products under the unified rules of the Eurasian Economic Union (EAEU).

Nanolek registers new drug to treat Hunter syndrome in Russia

Idursulfase beta, an original drug for the treatment of Hunter syndrome, a rare disease, was registered in Russia by Nanolek, a biopharmaceutical company, in cooperation with Green Cross, a South Korean company.

EAEU information system will be launched in less than a month

The common market information system, that allows pharmaceutical companies to submit their drug registration dossiers under two procedures in accordance with EAEU rules, is expected to start operating in Q1 2018.

First registrations of drugs under EAEU rules will take place in Kazakhstan

The pharmaceutical companies select the Republic of Kazakhstan as the reference country for registration of their products under the common market rules.

Roche Georgia holds a scientific conference in Tbilisi

The conference was organized under the aegis of the pharmaceutical company Roche Georgia and is connected to the introduction of the innovative drug Ocrevus (Ocrelizumab) onto the Georgian pharmaceutical market.

Russia registers its first domestically manufactured biosimilar of infliximab

The Russian Ministry of Health has registered BCD-055, the first Russian-made biosimilar of infliximab developed by BIOCAD, a biotech company. BIOCAD was developing the local biosimilar of infliximab since 2013.

EMA published a new guidelines on evaluation of advanced therapy medicines

european medicines agency
The update aims to streamline some procedural aspects, strengthen collaboration between EMA’s scientific committees and address specific needs of ATMP developers in the evaluation procedure

Russian State Duma has approved draft law on developing the contract manufacturing

At its plenary session held on January 19, the deputies of the State Duma adopted at the first reading the draft law “On Amendments to the Federal law “On circulation of medicines”

Russia approves the plan for development of competition in the drug market

The Russian Prime Minister signed a Decree approving the road map for the Development of Competition in Health Care. The plan is aimed at developing the competition on commercial markets.

Russia has one of the shortest periods for expert examination of medicines

pharma manufacturing
Elena Maksimkina, the Director of the Department of Drug Supply and Regulation of Medical Devices, gave her assessment of the pharmaceutical market in Russia.

Russian government will support drug compounding

drug compounding
Russian government will give its backing to a drug compounding. Senators and experts discussed this matter in the press centre of "Parliamentary Gazette"

Draft law on accelerated registration of foreign medicines approved in Russia

government russia
The Government of the Russian Federation approved the draft federal law "On Amendments to the Federal Law on the Circulation of Medicines"

Authorities decide to simplify the entry of foreign drugs to the Russian market

Russian Ministry of Industry and Trade has prepared the draft law “On Amendments to the Federal Law On Circulation of Medicines”

Registration of medicines in EAEU will be performed online

The Eurasian Economic Union is completing the development of a unified information system that will facilitate the registration of medicinal products

Russia registers OCREVUS for treatment of multiple sclerosis

An official press conference was held to mark the registration of OCREVUS® (ocrelizumab) in Russia

Russia registers Tagrisso – an innovative cancer drug

AstraZeneca announced that it received the registration certificate in Russia for Tagrisso® (osimertinib)