Countries
RUSSIA
Beginning from 2010, the considerable changes have been implemented in the procedure of registration of drugs and pharmaceutical substances in Russia. The drugs are registered by the Ministry of Health of the Russian Federation. Availability of clinical trials conducted in Russia is a mandatory requirement for the registration in Russia. The drugs permitted for medical use in Russia for more than 20 years and for which the bioequivalence study is impossible to conduct, are not covered by such requirement. The registration of substances is cancelled. This procedure is called "inclusion into the pharmaceutical substances register" now.
The registration term is about 1 year without the time for clinical trials.
Official payments - from 30.000,00 rubles (1.000,00 USD) to 300.000,00 rubles (10.000,00 USD) depending on the registration type.
Our specialists are experienced in the field of drugs registration in the Russian Federation and they have been working for years in it, they have a good knowledge of peculiarities and special features of registration process."
UKRAINE
The drugs are registered by the national enterprise “State Pharmacology Center” of the Ministry of Health of Ukraine, upon the results of expert evaluation of the drug only.
The EU law was taken as a base for procedure of drugs registration.
GMP Certificate is a mandatory document of registration file. The registration file shall be submitted in CTD format.
The term of expertise has its strict deadline: 90 calendar days for the generic drugs, 210 calendar days for original drugs.
The price of registration is the same both for residents and non-residents of Ukraine. It comprises the state duty and cost of expert evaluation.
The procedure of registration of amendments to the registration file during the validity of Certificate of Registration is carried out according to applicable practice of EU — amendment of type 1 do not require the registration, and those of type 2 – require such registration (new dosage of the drug, bioavailability data etc.).
Renewal of drug registration shall be carried out at least 90 days before the expiry of the Certificate of Registration
The drugs shall be labeled in Ukrainian or in Ukrainian and any other language.
Term of registration – up to 10-12 months.
Official duties amount to 5 to 10 thousand US dollars during the procedure of registration.
REPUBLIC OF KAZAKHSTAN
State registration, renewal of registration and registration of amendments to the drug registration file in the Republic of Kazakhstan are carried out by the state authority for drugs, medical articles and devices circulation.
The drugs registration system is peculiar by territorial separation of authorized institutions and public authorities in the field of drugs circulation between two major cities – Alma-Ata and Astana.
The expert evaluation of a drug at state registration, renewal of registration and registration of amendments to the registration file consists of the following stages, according to the Decree of the Ministry of Health of the Republic of Kazakhstan dated November 18, 2009No. 735 “On approval of Rules of State Registration, Renewal of Registration and Registration of Amendments to the registration file of drugs, medical articles and devices”:
- Primary expert evaluation;
- Analytical expert evaluation;
- Specialpharmaceuticalexpertise;
- Special pharmacological expertise;
- Opinionon security, efficiency and quality
Since March 1, 2014 the applications for drug registration are accepted only with GMP certificate.
The drugs are labeled in Kazakh language. The term of registration - from 10 to 14 months.
Official duty payable during the procedure of registration amounts to 5 000 US dollars
REPUBLIC OF BELARUS
Unitary Enterprise “Center of healthcare expert evaluations and tests” is charged of the state registration (renewal of registration) of the drugs, pharmaceutical substances, medical articles and devices in the Republic of Belarus.
The registration system is peculiar by its similarity to the procedure applicable in Russia.
The drugs are labeled in Russian.
According to Letter of the Ministry of Health of the Republic of Belarus dated March 21, 2013 No. 01-08-07/2085 "On optional submitting of registration file in CTD format", the applicant may submit the file in CTD format for drug registration.
The term of registration varies between 6 and 8 months.
Official duty payable during the procedure of registration amounts to 3 000 US dollars
REPUBLIC OF UZBEKISTAN
General Department of Drugs Quality Control, being the unit of the Ministry of Health of the Republic of Uzbekistan, is charged of state registration (renewal of registration) of drugs and pharmaceutical substances.
The operations of the General Department are managed by four committees: Pharmacopoeia, Pharmacology, New Medical Devices, Narcotics Control and department of metrology. The Resolution on registration of the drug shall be approved by the Board of Experts of Department of Drugs Quality and Medical Devices Control.
Uzbekistanrequires the availability of drug registration in other countries, in addition to the manufacturing country, as otherwise, the clinical trials in the territory of Uzbekistan may be prescribed.
The Uzbek authorities accept within the registration file the normative documents and directions for use, approved in the Russian Federation.
The term of drugs registration is up to 6 months.
Official duty payable during the procedure of registration amounts to 5 000 US dollars
REPUBLIC OF TAJIKISTAN
The requirements and rules applicable to the drugs and pharmaceutical substances registration in the Republic of Tajikistan resemble most closely those of the most of CIS countries.
Average term of registration – up to 6 months.
The drugs labeling is approved in Russian or any other language (English, French, etc.).
Procedure of drugs registration in the Republic of Kyrgyzstan is almost the same like in the Republic of Kazakhstan due to close location and cultural traditions.
REPUBLIC OF KYRGYSTAN
Procedure of drugs registration in the Republic of Kyrgyzstan is almost the same like in the Republic of Kazakhstan due to close location and cultural traditions. The drug label shall be in Russian, but the international labeling is possible too.
The term of registration - up to 6 months.
Official duty payable during the procedure of registration amounts to 1 000 US dollars
