“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
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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!
Last week we had intensive and colourful two days of Strategy in Drug Regulatory Affairs Course.
All participants of the training were fascinated by our trainer Andrew Willis – Regulatory and Development consultant with 30 years of experience. He shared his knowlegde and experience so enthusiastically that all complicated things became clear by learning from practical examples, based on real life situations.
Thanks again to our amazing trainer and also to all participants!
Rephine Balticum will be participating at the Global Pharmaceutical Regulatory Affairs Summit on 24-26 October in Prague.
WHAT WILL YOU HEAR ABOUT?
The conference includes 4 parallel conference tracks on Regulatory Affairs in Emerging Markets, IDMP Compliance, Global eSubmissions and Biosimilars. Dr. Polina Dombure will represent Rephine Balticum with speach on topic “Bridging East and West: GxP Convergence within the CIS”.
You are welcome to attend this event.
Your invitation from Rephine Balticum means you can benefit from an exclusive 25% discount when you register with the VIP code: CQ5267RBA*.
Places are limited, but you can guarantee your place below.
Book online: Click here to book online
Book by email: firstname.lastname@example.org
Book by telephone: +44 (0) 20 7017 7481
Group booking (3+) discounts: +44 (0) 20 7551 9521
* T&Cs Apply
Looking forward to meeting you at the Summit!