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:
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.
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).
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.|
e-Submissions of your documents is no longer the future!
|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.|
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:|
|Contact us to learn more about eCTDmanager with the user interface in Russian in EAEU and CIS countries region!|
Press for enquiry here: email@example.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.
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.
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.
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.
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.
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.
And Taras Lyaskovsky, representing the Ministry of Health of Ukraine, informed about the nuances of the drug registration system in the Ukrainian market.
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 firstname.lastname@example.org 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!
“Regulatory Information Management in the era of globalisation”, will be the theme of this year’s event. Around 25 leading experts from industry and regulatory authorities will share their experiences and knowledge.
What you will gain by attending to eRA 2019?
Who should attend?
CIS partners meeting
Get an added value by joining the CIS region Partners meeting on 1st day – 22nd May.
Event details and registration
22-23 May, 2019
|eRa Conference Venue:
|By registering hereby you will get all for your travel arrangement (VISA, flights, hotel, transfers)|
The survey indicates that some companies need to step up efforts to ensure medicine supply in the EU
A recent European Medicines Agency (EMA) survey shows that marketing authorisation holders for more than half (58%) of the 694 centrally authorised products (CAP) with an important step in their regulatory processes in the United Kingdom (UK), are on track with their regulatory planning to ensure that their marketing authorization remains valid once the UK leaves the European Union (EU).
Regulatory authorities and marketing authorization holders both play an important part in preparing for the consequences of Brexit to safeguard the continuous supply of human and veterinary medicines after the withdrawal of the UK from the EU. Since May 2017, the European Commission and EMA have informed companies and raised their awareness of the need to put the necessary measures in motion. Information notices on legal issues and guidance on practical and simplified requirements for companies have been published and regularly updated.
For marketing authorisation holders of CAPs, this may imply changes to the marketing authorisation itself, including, for example, a transfer of the marketing authorisation to a legal entity established in the European Economic Area (EEA), or a change of the qualified person for pharmacovigilance (QPPV) or pharmacovigilance system master file (PSMF) to a location in the EEA, as well as adaptations to their logistics, manufacturing sites, supply chains and contracts.
However, for 108 (88 human products and 20 veterinary products), or 16%, of these medicines with manufacturing sites located in the UK only, there are serious concerns that the necessary actions will not be carried out in time.
For 10% of the products included in the survey, EMA received no feedback from companies.
The aim of the survey, which was launched in January 2018, was to identify CAPs that are potentially at risk of supply shortages and to obtain information on the timelines for submission of the necessary regulatory changes. The survey was sent to marketing authorization holders of the 694 CAPs (661 human and 33 veterinary products) who are located in the UK or who have quality control, batch release and/or import or manufacturing sites, or a QPPV or PSMF in the UK.
According to EU law, the marketing authorization holder, the QPPV, the PSMF, and certain manufacturing sites need to be based in the EEA for a company to be able to market a medicine in the EU.
EMA is liaising directly with the marketing authorization holders who either did not reply to the survey or have indicated in the survey that they do not plan to submit the changes required by 30 March 2019 and have manufacturing sites in the UK only, as this could potentially lead to supply disruptions.
EMA has analyzed feedback from the survey and is now looking in detail at those medicines where there are risks of supply shortages and will assess how critical these are. As a regulator, EMA’s role is to ensure that it has a complete overview of the potential risks and to work together with the relevant marketing authorization holders to address these risks as early as possible and discuss relevant mitigation measures.
EMA will also regularly monitor the submission of changes to marketing authorisations for all 694 products to check if the relevant variations/notifications are being submitted. Figures are likely to change as regulatory changes are submitted.
EMA urges those companies who have not yet informed EMA of their Brexit preparedness plans to do so as soon as possible to mitigate any risks to the continuous supply of medicines for human and veterinary use within the EU.
Companies are reminded to plan for the UK’s withdrawal from the EU on 29 March 2019 and are advised to regularly check EMA’s dedicated webpage on the consequences of the UK’s withdrawal from the EU. In particular, EMA encourages companies to refer to the updated questions and answers and practical guidance for industry published on 19 June 2018.
На заседании Коллегии Евразийской экономической комиссии (ЕЭК) 17 июля 2018 года утверждено Руководство по общим вопросам клинических исследований. Коллегия Комиссии рекомендовала государствам ЕАЭС использовать этот документ при проведении исследований препаратов для их регистрации согласно Правилам регистрации и экспертизы лекарственных средств для медицинского применения.
Руководство определяет основные принципы планирования и проведения клинических исследований лекарственных препаратов, включая защиту человека как субъекта испытаний. В частности, в процессе разработки препарата в интересах безопасности испытуемых должны учитываться результаты вновь появляющихся токсикологических и клинических исследований.
Кроме того, в документе содержится единая классификация клинических исследований и рекомендации по количеству пациентов, которые должны пройти испытания для оценки безопасности лекарственных препаратов.
Оба руководства относятся к актам третьего уровня, необходимым для безопасной работы союзного рынка лекарственных средств. Шестьдесят семь актов третьего уровня, запланированных к разработке в 2016-2018 годах, призваны обеспечить единообразие применения в рамках Союза установленных требований в сфере обращения лекарственных средств. Готовящиеся руководства и рекомендации конкретизируют отдельные вопросы разработки и изучения лекарственных препаратов, их производства, детализируют и формализуют инспекционные процедуры, представляют для производителей лекарственных средств указания по формированию досье лекарственных препаратов, а также регламентируют ряд вопросов, связанных с производством лекарственных средств из лекарственного растительного сырья.
Принятая модель регулирования обеспечит качество, эффективность и безопасность лекарственных препаратов для населения государств Союза, а также оптимальные условия для развития фармацевтической промышленности и повышения конкурентоспособности продукции.
Источник: Пресс-служба ЕЭК.
На заседании Коллегии Евразийской экономической комиссии (ЕЭК) 17 июля 2018 года рассмотрены вопросы в сфере технического и таможенного регулирования, работы союзного рынка лекарственных средств, конкуренции. В частности, Коллегия ЕЭК утвердила Руководство по валидации аналитических методик и Руководство по общим вопросам клинических исследований. Руководство по валидации аналитических методик определяет подходы к валидации четырех наиболее распространенных типов испытаний: идентификация (проверка на подлинность), определение количественного содержания примесей, установление предельного содержания примесей, а также оценка количественного содержания или активности действующего вещества в лекарственном препарате.
Кроме того, в документе установлены случаи, когда может быть необходима повторная валидация (ревалидация) методики. Она понадобится при изменении схемы синтеза фармацевтической субстанции или состава лекарственного препарата.
Использование валидированных методик контроля качества позволит гарантировать, что небезопасный лекарственный препарат будет изъят из обращения до его поступления в аптечную сеть и приобретения пациентом.
Источник: Пресс-служба ЕЭК.
On July 10, 2018, in Sofia Vladislav Shestakov – Director of the State Institute of Drugs and Good Practices, Deputy Head of the State GMP Inspectorate met with Professor Assena Stoimenova, Executive Director of the Bulgarian Drug Agency (Medicines Agency of the Bulgarian Health Ministry).
The State Institute of Drugs and Good Practices and the Bulgarian Medicines Agency signed a bilateral agreement that covers professional exchanges and timely notification on anticipated inspections and critical non-compliances. The inspectorates extended invitations to the major pharmaceutical events: the first in history joint conference of Bulgarian-Cuban regulators, GxP summit for university students and postgraduates, as well as the 3rd All-Russia GMP Conference. The delegates also discussed the observers’ participation in pharmaceutical inspections, an organization of educational inspections, and joint educational programs development, supplementary education, and advanced skills projects.
“We continue to strengthen international cooperation between regulatory authorities, and by signing the present Agreement with the Bulgarian Inspectorate we made a big step towards our goal. Intensive interaction between our nations in the pharmaceutical industry fills me with great expectation: our discussion was not limited to regulatory issues only, we also talked about the future of the industry – our students,“ – said Mr. Shestakov.
Source: STATE INSTITUTE OF DRUGS AND GOOD PRACTICES of RUSSIA
EU and Japan reinforce their collaboration on inspections of medicine manufacturers
Update of 2004 mutual recognition agreement extends scope to sterile products, active pharmaceutical ingredients and biologicals including vaccines
The European Union (EU) and Japan have agreed to broaden the range of medicines for which they will recognise each other’s inspections of manufacturing sites.
The current mutual recognition agreement (MRA) between the EU and Japan has been operational since 29 May 2004. It allows regulators to rely on good manufacturing practice (GMP) inspections in each other’s territories, to waive batch testing of medicines that enter Japan from EU countries and vice versa and to share information on inspections and quality defects. Thanks to this agreement, regulatory authorities in the EU and Japan can make better use of their inspections resources by reducing duplication of inspections in each other’s territory.
The scope of this agreement has now been extended to include sterile medicines, certain biological medicines including vaccines and immunologicals, and active pharmaceutical ingredients (APIs) of any medicine covered in the agreement. This means that authorities from the EU and Japan have agreed that they have equivalent regulatory and procedural frameworks for inspections of manufacturers for these products and can therefore rely on each other’s inspections.
The full scope of the MRA now covers chemical pharmaceuticals, homeopathic medicinal products (as long as treated as medicinal products and subject to the GMP requirements in Japan), vitamins, minerals and herbal medicines (if considered as medicinal products in both parties); certain biological pharmaceuticals including immunologicals and vaccines, APIs for any of the above categories and sterile products belonging to any of the above categories.
In the EU, inspections of manufacturing sites are carried out by national competent authorities from EU Member States. In Japan, GMP inspections are conducted by the Pharmaceuticals and Medical Devices Agency (PMDA) and the 47 inspectorates of the prefectures.
This is the first update of the original MRA agreement. As part of the product scope expansion project, Japan also evaluated and recognised as equivalent all EU competent authorities for human medicines inspection.
- The biological pharmaceuticals, including immunologicals and vaccines, in the scope of the agreement are: medicinal products produced by cell culture utilising natural microorganisms or established cell lines; medicinal products produced by cell culture utilising recombinant microorganisms or established cell lines; and medicinal productsderived from non-transgenic plants and non-transgenic animals.
- The update of applicable legislation and recognition of the equivalence of all EU Member States was formalised through an exchange of Diplomatic Notes with Japan published in the Official Journal of the EU.
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.” This document invalidated the requirement for selling socially important medicinal products and medical devices at fixed prices.
From 1.08.2018, Uzbekistan will recognize the results of state registration of medicines, including medicinal substances and drugs, in the countries with high regulatory requirements.
Recognition will be carried out:
- by identifying the authorities of foreign states and international organizations responsible for the state registration of medicines, that raise no doubts in terms safety, quality and efficacy;
- subject to the permit for the use of medicines, the results of state registration of which are recognized in the Republic of Uzbekistan, in the medical practice of countries with high regulatory requirements.
Such medicines will not be submitted for expert examination during their state registration in Uzbekistan to establish safety, quality, and efficacy of these products.
By 1.12.2018, together with the Prosecutor General’s Office and National Agency for Project Management under the President of Uzbekistan, the Ministry of Health will take the inventory of medicines registered in Uzbekistan in terms of their prohibition for use in the countries with high regulatory requirements, examine the reasons and conditions for such prohibitions, and make proposals on the appropriateness of their further use in Uzbekistan.
It was our great pleasure to participate in Russian Pharmaceutical Forum in St.Petersburg. This is the foremost gathering of CEO’s of international and local pharmaceutical procedures, distributors and retailers.
In two days conference among 600 participants we met our good partners and clients, as well as got lot of new contacts.
Our Member of the Board Dr. Polina Dombure made a presentation on the topic: “Pharma online: how soon will we digitalise?”
See you in the next Russian Pharmaceutical Forum!
First time in our history we ran a training in Kiev.
And it was our great pleasure to let our clients meet our distinguished trainer Mr. Andrew Willis. This charismatic gentlemen has guided training’s in Latvia so far and we have really good experience with him.
Andrew is a regulatory expert with 31 years of experience in pharmaceutical development. Experience at multiple levels within pharmaceutical companies and most recently as Vice President for Regulatory Affairs, gaining significant experience in co-ordinating, planning and running global development projects.
His experience is wide ranging, and will facilitate your under- standing of fast, effective development of medicinal products, through early stages, through registration and continued Life Cycle Management.
Looking forward to meeting you in Andrew’s next training in Riga November 22-23, this year!
Our company had the pleasure to participate in DIA Europe 2018.
As one of the highlights this spring, DIA Europe 2018 brought together representatives from the entire healthcare value chain in Basel, Switzerland, midway through April.
Fully agree with organizers – DIA Europe 2018 is more than just a traditional meeting. It’s a chance to learn, engage, and grow as a professional in health care. We were proud to be a part of this member-driven, global association that mobilizes life sciences professionals from across all areas of expertise.
Besides 2018 is the 30th anniversary of the DIA EuroMeeting. Well done and keep it up!
See you in Vienna in 2019!
It is our great honour to announce the opening of our representative office in Kiev. Now getting closer to our clients, getting more effective and more pofessional.
Please visit us:
Suite 4, 8 Panasa Myrnoho Street,
Kyiv, 01011, Ukraine
Phone: +380 44 569 01 06
Facsimile: +380 44 569 01 06
Last week we participated in world’s leading startup event SLUSH in Helsinki, Finnland.
This year over 2 600 startups, 1,500 venture capitalists, and 600 journalists from over 130 countries gathered to Slush to drive business. Latvia was represented by more than 27 companies and more than 100 individual entrepreneurs.
It was our pleasure to be in Helsinki. And we wish lot of success to participants of next SLUSH events!