The Board of the Eurasian Economic Union has published decisions on the electronic submission of drug applications. These include decisions 78 and 79 of the board.

On 3rd August 2017, the Committee of the Eurasian Economic Union (EAEU) released the standards for EAEU electronic submissions. What will be the impact on applicants that would like to register a new drug in the EAEU? Is it the same as the ICH eCTD, only with a new regional module M1? What are the guidelines that need to be followed?

The Board of the Eurasian Economic Union has published decisions on the electronic submission of drug applications. These include decisions 78 and 79 of the board.

Decision 78 gives details and clarifications on content & structure of the submissions. For existing applicants, this will involve changes in regulatory requirements. Due to the change of the modules / sections structure, existing applications will have to be re-structured to adapt the new structure and to comply with the current requirements. In general, the whole application procedure will change. From 31st December 2020, applicants will no longer be able to submit new applications as a national procedure, it will be replaced by either Decentralized Procedure (DCP) / Mutual Recognition Procedure (MRP)

Decision 79 of the board gives details on technical compliance of the electronic submissions. Additional XML files need to be provided alongside with the PDF documents for a drug application. The XML for the application form is known as “R.017” which contains information on the applicant company, the product, and the substance. A second XML “R.022” contains information on the documents submitted, together with specific identifiers for each document type.

Document quality is essential, and all scanned PDFs need to be OCR processed in order to be searchable. No corrupt PDF files should be submitted. Password protection is also not advised in order to allow the reviewers to open the documents. There is a maximum file size restriction of 100MB for the documents.

Timelines for submitting in the new electronic format to the EAEU were published as follows:
New marketing authorizations in the EAEU have to be compliant with the new, electronic submission format from 31st of December 2020 onwards. Follow-up submissions are mandatory to be submitted in the electronic format from 31st December 2025.

What does this mean for the applicant? What are the to-dos?

For all your existing applications, already approved in one of the EAEU member states, you should start getting prepared for the transition to the electronic format by:

  • updating the content and structure of your application to be compliant with decision 78
  • making documents electronic by scanning / OCR processing or creating new ones
  • additionally, it is advised that you submit a baseline submission of your existing dossier in electronic form

If you don’t have an existing, approved application already within one of the EAEU member states, you are now able to start your application directly in the electronic format.

5 modules use XML files for metadata – so, is it eCTD?

The submission format to the EAEU is not a regional implementation of the existing ICH eCTD standard, as seen in Europe, USA, Canada or Australia implementations. It does have some similarities with eCTD submissions, especially when it comes to structuring and modules. Instead, the EAEU submission format has its own, quite advanced but different XML format to submit additional data on application, documents and lifecycles. This also clearly separates it from NeeS – the predecessor of eCTD. Sometimes you might hear it being referenced to as the “eCTD for Eurasian Economic Union / EAEU” – but don’t get confused by this, as technically it is a new and independent standard of its own, not related to established eCTD standard.

Whether you’re based in the EAEU or anywhere else in the world, if you’re looking to submit electronic submissions in the EAEU, then EXTEDO has the technology and expertise you need.

Would you like to register a new drug in the EAEU? Contact Inpharmatis to know more – the named partner of Extedo GmbH.

It was our honour to participate at Conference IV All-Russia GMP Conference (IV Вcероссийская GMP-Конференция) “GOOD PRACTICES: BRINGING INDUSTRY AND THE WORLD TOGETHER” on 23-25 September.

This year GMP Conference conference was held in Svetlogorsk, Kaliningrad region. The conference annually brings together leading international and Russian experts in the pharmaceutical industry, government representatives, managers and specialists and experts in the field of the quality management system and good manufacturing practice (GMP).

Inpharmatis team in GMP Conference 2019

Over 1000 GMP experts from Russia, Asia, Europe, and the USA were discussing actual problems in the Russian and global pharmaceutical markets, as well as the role of good practices in assuring the quality of pharmaceutical production and international cooperation.

The Conference was organized by the Ministry of Industry and Trade of the Russian Federation together with the «State Institute of Drugs and Good Practices».

Inpharmatis provide full-scope Good Manufacturing and Distribution Practice Services to ensure your compliance with the relevant EU and CIS legislation. We were pleased to participate in such a conference where professionals all over the world share experience, discuss topical issues as integration processes in the context of EAEU and challenging issues of GMP inspection in Russia and other countries.

Meet you next year!

 

We are currently providing the only solution which is compliant to Rules No. 79 of EAEU by offering quick and efficient e-dossier creation for this region. 
We propose the rapid implementation of a sophisticated and compliant system of eCTDmanager for your affiliate offices or publishing services for EAEU.
The eCTD standard is now used extensively within Europe and the US and is gradually being rolled out in EAEU and CIS region countries. As this roll-out continues, organizations need to prepare themselves for the new way of working. This will mean additional effort in the short-term, but by ensuring that processes and software are updated and optimized businesses can best take advantage of the opportunities eCTD provides.
Quality eCTD submissions can save your organization money, increase the accuracy of the submission and decrease review times. 
Wherever in the world, they are based, pharmaceutical companies should be preparing for the arrival of electronic submissions and not wait until final local guidance is released. eCTD-readiness should be a priority for everyone.
 

Full eCTD information in RUS

e-Submissions of your documents is no longer the future!

Full eCTD information in ENG

eCTDmanager is your complete regulatory dossier assembly and management solution. 
It provides you with a complete regulatory dossier assembly and management solution. It is scalable, all-in-one submission management capabilities meet the requirements for both electronic and paper submissions. 
eCTDmanager enables you to build, view, validate and publish compliant submissions based on eCTD, NeeS, eCopy, IMPD, CTA, PIP, VNeeS, DMF, ASMF, and other regional formats. eCTDmanager significantly improves the quality and consistency of your submissions, proving a powerful hyperlinking and bookmarking engine that allows the detection, notification, and correction of broken links. 
eCTDmanager enables you to streamline your global submissions by ensuring full compliance with ICH and regional specifications.

 

Request demo 

Working with eCTD management software solution eCTDmanager ensures a fast and accurate generation and life cycle management of Your eSubmission.

Your company’s main advantages for using eCTDmanager are: 
  • Process efficiency
  • Cost reduction
  • Faster time to market
Contact us to learn more about eCTDmanager with the user interface in Russian in EAEU and CIS countries region!

Press for enquiry here: info@inpharmatis.com!

 

We had a pleasure to spend two intensive days in the eRA 2019 Conference which was held in Munich this year.

Since 2006 the e-Regulatory Affairs conference, more commonly known as just eRA, has provided a unique learning and networking opportunity for regulatory affairs professionals from around the globe. And this year was no exception. With the Conference theme “Regulatory Information Management in the era of globalization” 20 leading experts from industry and regulatory authorities shared their experiences and knowledge.

The Conference took place at the beautiful Eurostars Grand Central Hotel from 22nd to 23rd May.

inpharmatis era conference stand

This year for the first time happened CIS region Partners meeting.

At a special session for the CIS countries, Health authorities and leading industry experts introduced with all the innovations in regulatory matters relevant to companies operating in the EU and CIS markets.

inpharmatis era conference hall

Health authority and leading expert Konstantin Koshechkin shared his knowledge not only at the conference’s main session but also at a special session for the CIS countries. His area of expertise lies at the junction of IT and pharmaceuticals. Konstantin Koshechkin takes part in the implementation of a number of projects of the Ministry of Health of the Russian Federation related to the automation of document flow and certification, the improvement of the system for evaluating information on the safety of medicines, the validation of pharmaceutical information systems, etc. With brilliant presentations, all the participants had the opportunity to learn the algorithm for the formation of a dossier in electronic form and how to prepare for the transition to eCTD.

Inpharmatis CIS session Koshechkin

Also, a representative from the Center for Examinations and Tests in Health Service State Enterprise of Belarus Tatiana Shamstudinova with impressive presentation introduced us with features of the execution of national registration procedures in the Republic of Belarus and their comparison with the requirements of the EAEU.

Inpharmatis CIS session Belarus presentation Tatiana Shamstudinova

Anvarbek Moldotashov, an expert of the Department of Provision and Medical Equipment under the Ministry of Health, told about the present and future of e-regulation of the pharmaceutical market of Kyrgyzstan.

Inpharmatis CIS session Anvarbek Moldotashov Kyrgyzstan presentation

The expert of the Scientific Center of Drug and Medical Technology Expertise Narek Baghdasaryan shared the specifics of the registration of medicines in the sunny Republic of Armenia.

Inpharmatis CIS session Armenia presentation Narek Baghdasaryan

And Taras Lyaskovsky, representing the Ministry of Health of Ukraine, informed about the nuances of the drug registration system in the Ukrainian market.

Inpharmatis CIS session Ukraine presentation Taras Lyaskovsky

The conference brought together leading experts in the implementation of electronic standards in different countries, led by the leader in the development of IT systems for managing regulatory information – the company EXTEDO.

During the conference, all participants and speakers had a chance to know the policymakers in the pharmaceutical industry, make useful connections, learn about the experience of implementing information systems and new IT products that simplify the process of e-registration of drugs. Our Inpharmatis team spent both conference days meeting with eCTD developers and users. Meeting with Health authorities and leading experts from industry and regulatory authorities we have enhanced our knowledge and abilities. And we are ready to give it to you!

Inpharmatis, the organizer of the session for the CIS countries, warmly thanks the speakers and all the participants! See you at the next events!

Meet the future today and implement eCTD now!

Contact us via e-mail info@inpharmatis.com and be the first to get the latest updates!

 

Meet us at Conference RegLek EAEU 2019 “Examination and Registration of Medicines in the EAEC” in Moscow on 15th and 16th April.

This year’s Conference is dedicated to the registration of medicines as part of the work in the common customs area of the Eurasian Economic Union. The Conference will provide an opportunity to learn about recent changes in the current regulatory framework of the EAEU pharmaceutical market, preparation and prospects for the introduction of the EAEU Pharmacopoeia, requirements for the formation of an electronic dossier on the ECE Rules.

You will also have an opportunity to find out from industry experts and educated speakers about particular issues of assessing the ratio of expected benefits to the possible risks of using drugs in the framework of modern legislation and examination of immunobiological and biotechnological drugs.

Besides that, speakers will educate about compliance with the requirements of international quality standards in the process of circulation of medicines on the market of the EAEU and development of the quality management system of a pharmaceutical company in the light of recent regulatory requirements.

Meet you here!

It was our great pleasure in cooperation with our good friends SAP for the first time to organize the event “Digital Pharma: Intelligent Pharmaceutical Enterprise”. The event took place in Kiev on 11 April.

Among 30 participants we met Chief Information Officers (CIO), Project and Sales Managers, Business and Pharmaceutical Managers from different companies.

The day was very saturated and informative. As the participants themselves admitted, the event was immensely useful, they got information on current developments and trends in the pharmaceutical industry.

Engaging presentations were made by representatives of companies such as Deloitte Ukraine, Darnitsa, Acino Pharma Start, Farmak, WTF Consulting, Benoy, SaM Solutions, De Novo and of course Inpharmatis and SAP Ukraine.

The main focus of the event was:

Business Transformation + Innovative IT Solutions = Company Success + Industry Development.

We would like to thank SAP for excellent cooperation. And we are already planning the next events so follow the information on our website and social networks.

      Also this year our company had a pleasure to participate in DIA Europe 2019. The annual DIA Europe meeting took a place in Vienna, Austria from 4th to 7th February.

      We were proud to be a part of life science professionals, industry experts and educated speakers. Also, our team was honoured to introduce industry professionals and each stakeholder with presentation about “Prudenta: an electronic solution for local literature monitoring in pharmacovigilance”.

            During intensive three days we created meaningful connections, uncovered and presented new ways of working and solutions and we charged with positive energy.

      DIA Europe has become a landmark, must-attend event for life science professionals from across the entire drug development spectrum – from discovery to marketed use, to facilitate open collaboration by incorporating representatives from the full life sciences landscape.

      See you in DIA Europe 2020!

          Our company had the pleasure to participate in the world’s largest pharmaceutical exhibition, CPhI Worldwide on 9-11 October 2018 in Madrid.

          For the first time in our history, we were honored to participate in such a large-scale worldwide exhibition.
Our Member of the board Dr. Polina Dombure made a presentation about “CIS Market: Regulatory Strategies in Dynamic Convergence“, also including a presentation about Prudenta, a solution for monitoring adverse drug reactions in the local medical literature.

          CPhI Worldwide houses six individual pharma events covering all industry sectors.
We can not disagree that CPhI is uniting over 45,000 pharma professionals from around the globe and more than 2,500 international exhibitors and it is the place to network and source cost-effective pharma solutions from all over the world.
In just three days under one roof, we had a chance to connect & network with international exhibitors and pharma professionals.

          See you in Frankfurt next time!