drugs registration

CRO in Russia - Clinical Excellence Group (CEG)

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Russian pharmaceutical market

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clineg.com/drugs-registration

Registration of Drugs
in Russia and the Eurasian Economic Union

Your company will successfully launch new drugs to the Russian and the EAEU market.
Drugs of any type: original, generic or biosimilar.
All stages are in time.
You will enjoy the quality and reliability of our services and our commitment to result.

Russian Market

The Russian pharmaceutical market (#14 in the world) is one of the fastest growing globally and is set to rise from 1 629 billion Rub. ($28.3 billion) in 2017 to $38.6 billion by 2021, representing a compound annual growth rate of 13%.

Sales in physical terms grew by 6% and made 6.3 billion packages (2017 vs. 2016).

The impressive market size is determined by numerous factors, with the primary one being the total population - 143.5 million people (according to the Federal State Statistics Service as of August 1, 2013).

By the end of 2017, In terms of money, imported drugs lead in sales (70% versus 30%), whereas in phisical terms the leader are drugs produced on the Russian territory (62% of the total market volume).

Originators vs. generics: in money - 36% vs. 64%; in packages - 12% vs. 88%.

Rx vs. OTC: in money - 64% vs. 36%, in packages - 43% vs 57%.

There are 9 000+ trade names (brands) on the market.

"State" share (hospital purchases and reimbursable drug coverage) vs. commercial market volume are 32% vs. 68% in 2017.

Read more on the following web resources:
Global Data, 2017
DMS Group - Annual Report 2017
EFPIA - The Pharmaceutical Industry in Figures. Key data 2018
EFPIA - Russia: Key concerns of the pharmaceutical industry 2017
IFPMA, 2017
Deloitte - Russian Pharmaceutical Market Trends in 2017
AlPharm, 2017 vs 2016
Evaluate Pharma - World Preview 2018, Outlook to 2024
PWC, 2017

The population of the EAEU is 185+ mln. people. Russia is a largest country of the Union.

In November 2016, EAEU Member States signed the entry into force of the united pharmaceutical market - it was launched in May 2017.

Since that time if your company registers a drug (medicine) in Russia, it can also sell this product in Belarus (about 9.5 million people), Kazakhstan (about 17.2 million people), Armenia (3 million people) and Kyrgyzstan (6 million people), i.e. on the market of more than 185 million people!
A special procedure for the registration in all EAEU countries must be done (see below).
In the coming years, the list of EAEU members is expected to be extended by candidate countries.

Visit the Information Portal of the Union.

Key Stages of the State Registration

The scheme is valid for generic drugs

1

Pharmaceutical Development and Nonclinical Studies are conducted, the Dossier for proposed Clinical Study(ies) is prepared, Pilot Batches (drug samples for R&D) are produced and imported to Russia.

2

The Dossier is submitted to the MH RF in order to obtain a Clinical Trial Authorization (a two-stage process that usually takes 4 months).

3

Clinical trial(s) are conducted (which involves lots of activities and interaction with research centers, local ethic committees, logistics and insurance companies) and the Final Report is prepared.

4

The Registration Dossier is developed. The Final Report and the Registration Dossier are submitted to the MH RF for an examination of quality (pharmaceutical expertise) and risk-benefit ratio (this typically takes 6 months).

5

The MH RF issues a Registration Certificate (Marketing Authorization) that allows to sell the new drug at the Russian / the EAEU market.

Registration Procedure

According to the current national regulations, all drugs that are introduced to the market should undergo a multi-stage procedure of state registration. Successful registration results in obtaining a Registration Certificate of the Ministry of Health of the Russian Federation (MH RF). How to launch new drugs to the Russian Market?

The whole process of drug registration can be broken down into five stages (see above).

Keep in mind that the registration scheme below is typical for generic drugs only, whereas for other types of drugs the second and third stage are usually repeated 2-3 times.
Why so?

The thing is that a registration process is heavily dependent on the type of drug. This goes for the development of a registration dossier and for the scope of nonclinical and clinical studies.

For example, a clinical bioequivalence study is sufficient for generic drugs in any oral forms, if it is possible to measure blood / urine levels of their active substances. For other generic drugs, a clinical study of therapeutic equivalence is performed.

Original and biosimilar drugs are subject to more strict examination, requiring a series of 2 to 3 registration clinical trials of Phase I, II and III and a large set of nonclinical studies.

And such "details" are numerous. "Details" that directly affect your project's success: the timeliness of the drug's "launch", its payback period, the efficacy of marketing activities and, consequently, sales.

You may be familiar with a situation, when, contrary to your plans, the project deadlines are tragically missed, the costs unexpectedly double and the quality of the work itself leaves much to be desired. In other words, attempts to solve your tasks lead to new problems.

Take a look at our offer and learn how to avoid difficulties and accomplish your goals.

We guarantee: your company will successfully launch new drugs (medicinal products) to the united market of Russia and other EAEU countries. A drug of any type: original, generic or biosimilar.
All work stages from the idea to receipt of the Marketing Authorizations will be completed as scheduled.
You will enjoy the quality and reliability of our services and our commitment to result.

How can we help your company?

We make a Preliminary Examination of the drugs' composition, quality, dosage form, therapeutic indications etc. (to determine the possibility of launching them as drugs and to develop optimal regulatory strategy).

If needed: we make Marketing Study for your company's products and determine competitors and their sales.

If needed: we develop Sales and Financing Plan, estimate financial indicators, taking into account product strategy and expenses after product launch.

We develop a Project Plan, Timeline and Budget of drugs' state registration in Russia / the EAEU.

We organize translation of all source documents into Russian.

We provide consultation on manufacturing and quality of laboratory batches of the drugs.

We organize import of non-commercial samples of drugs and their components.

We provide consultation on Russian and EAEU regulations to manufacturing, quality, registration, clinical trials, nonclinical and observational studies, promotion of drugs.

We register pharmaceutical substances (APIs) (for drugs that are planned to be manufactured in Russia) and medical devices (as components of some drugs).

We plan and organize Non-Clinical Studies.
See the details here.

We plan and organize Clinical Trials (Phases I-IV, Bioequivalence, Therapeutic Equivalence).
See the details here.

We develop Dossiers for obtaining Ministry of Health's (MoH's) Clinical Trial (CT) Authorizations, submit the dossiers to the MH RF in paper and electronic formats.
See the details here.

We find Investigation Sites (Research Centers) and obtain necessary documentation from them and their Independent (Local) Ethics Committees (IEC).
See the details here.

We receive Clinical Trial (CT) Authorizations from the MH RF and IECs.
See the details here.

We carry out all stages and activities of the Clinical Trials, including patient recruitment, monitoring, participants' insurance, pharmacovigilance, logistics and data management, QA / QC.
See the details here.

We perform comprehensive Data Management and Statistical Analysis.

We prepare Clinical Trial Reports in compliance with requirements of Russia, the EAEU and international requirements; if needed - FDA, EMEA etc.

We develop Registration Dossiers (documents of the administrative, pharmaceutical and clinical parts - CTD, Modules 1-5) in compliance with requirements of Russia, the EAEU.

We submit the dossier(s) and represent your company during review (examinations) of quality and risk-benefit ratio at the MH RF.

We obtain the Marketing Authorizations (the State Registration Certificates) valid in Russia / all EAEU countries, and transfer all the documents to the Customer.

What you get when you work with us?

You use our broad expertise and individual approach to your tasks.
We will work together to define your goals. We develop an optimal plan of drug registration and scope of studies.
You may decide to perform a certain part of works on your own. We will support your decision and offer you to complete the remaining works.
Executive staff and key specialists of CEG have profound knowledge and vast experience in drug registration, nonclinical and clinical studies.
You can see for yourselves, when you receive answers to your questions or, for a start, take a look here.
You will know all details of your project before its start and before we sign a contract. More predictability - no worries!
You will be provided with a Budget and Timeline of your project in just 3-7 days after contacting us and discussing the details.
We know, that it is crucial to understand, what investments are needed and at what stages, how long the overall registration process will take, and when exactly new drug and reference medicines will be needed.
And yes, it is free of charge.
We are cooperating with 15 companies and have 23 registered drugs in our portfolio.
We completed 19 Clinical Trials, 40+ Non-Clinical Trials.
Additionally, CEG executive staff and key specialists have coordinated the state registration of 100+ generic and original drugs in Russia, Ukraine, Belarus and Georgia, as well as organized 120+ Phases I to IV, BE, TE Clinical Trials and numerous Non-Clinical Studies.
Unique expertise in biostatistics and medical writing.
Do you want to register a drug that is "difficult-to-launch"? Such as an anti-tumor medicine, a drug for treatment of HIV infection, pregnancy complications, brain disorders, severe infections? Or maybe a psychoactive drug?
Call or e-mail us and we will help you. Our team includes 6 unique medical writers and biostatisticians - there are only few such professionals in Russia and bordering countries.
And yes, we could develop dossiers and other files in English.
Right proportion of price and quality.
The cost of "turnkey" projects on registration of medicinal products depends on multiple factors. Anyway, our prices 3-4 times lower than those of large Contract Research Organizations in Russia.
We need just 3-5 days to communicate you the precise cost for registration of your products.
The affordable costs of our services combined with their high quality are a strong argument to work with us.
We carefully listen to our clients and usually respond to the query in 24 hours
So you can always be sure that the solution of current issues is not being delayed.
CEG has standardized business processes, so that you can be confident in quality and timeliness of accomplishing your goals.
Our work is guided by standards established on the market of drug registration and studies.
This goes for development and implementation of 38 Standard Operating Procedures (SOPs) and Policies, 100+ Standard Forms, Logs and Tables that regulate organization, monitoring and audit of clinical trials, selection of research centers, logistics, drug circulation, pharmacovigilance and study participants' safety, conduct of nonclinical studies, adverse event handling and many other activities.
This is an additional guarantee of your project's success.
Our team is constantly improving. And we really mean it.
Six of our specialists have more than 7 years of work experience in pharmaceutical companies and international contract research organizations, four specialists have more than 12 years of experience.
Our managers on nonclinical and clinical studies, regulatory affairs and data management attend workshops and conferences.
In 2012-2016, CEG successfully passed 5 audits by international Sponsors.
We hold semi-annual courses on Good Clinical Practice (extended GCP training) for company staff and external attendees. Each course lasts 4 weeks and includes 14 three-hour sessions.
Every year our company's staff takes an assessment of knowledge of Standard Operating Procedures and the legislation of Russia and the Eurasian Economic Union.

2-8 times more profitable!
Our knowledge of the market and experience in tenders allow us to argue, our prices are 2-4 times lower than those of large Russian Contract Research and Service Organizations.
And 5-8 times lower than those of international Contract Research Organizations!
But, of course, high-quality solutions and solid guarantees cannot be cheap.
Keep in mind: we will provide you with a comprehensive solution that encompasses all stages of drug registration rather than isolated services.

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