Tag: Drug Registration

Mepolizumab for eosinophilic asthma treatment was registered in Russia

GSK announced the registration of Nucala (mepolizumab) in the Russian Federation to be used as add-on maintenance treatment for severe eosinophilic asthma in patients over 18 years old.

Russia has the shortest period of drug registration to date

This was announced by the Minister of Health the Russian Federation, Veronika Skvortsova, at an expanded meeting of the State Duma Committee on Health Protection.

AstraZeneca resumes sales of Nexium in Russia

AstraZeneca, a biopharmaceutical company, announced that it registered new maximum ex-work prices in Russia for the tablets of Nexium (esomeprazole) included in the List of Vital and Essential Drugs (VED List).

Russia registered a unique drug for the treatment of proctological disorders

nova medica
NovaMedica, a Russian pharmaceutical manufacturer and portfolio company of RUSNANO, has registered Fissario®, a unique drug for the treatment of proctological disorders.

Registration of prices for medicines in Belarus will take no more than 1-2 months

This was announced by the Deputy Head of Department for Social Sphere and Services of the Belarusian Ministry of Antimonopoly Regulation and Trade - Daria Orlova.

Uzbekistan admits drug registration from countries with high regulatory requirements

On 20.06.2018, the President of Uzbekistan signed a decree “On measures to improve the efficiency of state registration of medicines and their provision to the public.”

EEC changed rules for registration of vaccines and use of GMP certificates

The Council of the Eurasian Economic Commission (EEC) has amended the rules for registration and expert examination of medicinal products for human use in the Eurasian Economic Union.

Russia is expected to simplify the registration of a dosage form

The state registration of generic drugs in the form of concentrates for solutions will no longer require a report on bioequivalence studies. A relevant draft law was adopted by the Russian State Duma in the first reading.

Russia amended procedure for state registration of some medicinal products

pharma manufacturing
The following amendments are introduced to the Russian Federal Law “On Circulation of Medicines" with regard to the state registration of medicinal products.

Russian biosimilar of rituximab was approved for registration in Cuba

Cuban Ministry of Health (CECMED) approved for registration the biosimilar of rituximab manufactured by BIOCAD, a Russian biotech company. Supplies of this drug to Cuba are scheduled for the end of 2018.

State Duma adopted a bill to simplify registration of drugs

drug development
It will be possible to register drugs that have the same international nonproprietary names, but different trade names, and being manufactured at the same site. The corresponding government bill was adopted by the State Duma.

Russia may simplify registration of new antibiotics

This was announced by Sergey Glagolev, the Head of the Division for Monitoring the Efficacy and Safety of Medical Products, the Department of the State Quality Control of Medical Products of Roszdravnadzor.

EEC continues to improve EAEU common market of medicines

The Board approved the passport and procedure for maintaining the reference book of international nonproprietary names. The decision provides for its inclusion in the EAEU unified regulatory and reference information system.

Servier introduced its new Effient drug to the Russian market

Servier announced that sales of Effient®, its innovative last-generation antiplatelet agent, began in Russia in March 2018. The license agreement covering the territory of Russia was signed with Daiichi Sankyo in July 2016.

EEC approved the passport for drug classification system

The document will be used in electronic collaboration between the authorized bodies of the Union’s member states, including for the maintenance of EAEU unified register of registered medicines.

State Duma deputies propose to simplify registration of Russian medicines

The issues of legislative regulation and simplification of drug registration procedures were discussed by participants of the roundtable held on April 9 in the Russian State Duma.