Tag: Drug Registration

Results of FAS Head and Association of European Businesses’ Members Meeting

The Working Groups will help solve particular competition issues. A traditional meeting of Head of FAS, Igor Artemiev, with representatives of the Association of European Businesses focused on the ...

The Ministry of Health of the Russian Federation improves patent protection law

The Ministry of Health of Russia has published a notification on the development of amendments to Federal Law No. 61 of 12.04.2010 "On circulation of medicinal products"

Six new antiepileptic drugs will be registered in Russia

Six more drugs are in the final stage of clinical trials, Veronika Skvortsova, Minister of Health of the Russian Federation said at a briefing.

Sechenov University completed the creation of new Pharmacy training programs

Department of Pharmaceutical and Toxicological Chemistry of the Institute of Pharmacy at the Sechenov University and their foreign partners have completed creation of the new training programs.

Inflation rate should be considered during drug registration procedure in Russia

The Federal Antimonopoly Service draws the attention of owners or holders of registration certificates of medicines included in the list of vital and essential drugs (VED).

The Ministry of Health of Uzbekistan will reform drug provision

In 2018, 914.6 billion sums will be allocated to ensure the procurement of medicinal products and medical devices for state medical institutions in Uzbekistan, which is 2.5 times more than in 2017.

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.