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 presentation about Prudenta, 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 exibitors 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)|
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 authorisationholders 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 authorisationremains valid once the UK leaves the European Union (EU).
Regulatory authorities and marketing authorisation 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 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 authorisation 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 authorisation 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 authorisation 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 analysed 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 overiew of the potential risks, and to work together with the relevant marketing authorisation 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 authorisationsfor 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.