EMA relocation from London to Amsterdam

The European Medicines Agencies' Human Scientific Committees' Working Parties met in London with working parties for  Patients’ and Consumers’ Organisations (PCWP) and  Healthcare Professionals’ Organisations (HCPWP) for the last time in September 2018. These working parties have been meeting regularly in London for the last 5 years to share progress and expertise. From March 2019, the EMA will relocate to Amsterdam - its top priority business continuity for regulation and pharmacovigilance of medicinal products.

A key topic discussed was risk to disruption to the supply chain for centrally authorised medicinal products. 

Reasons:
- supply from the UK
- companies will have to make changes to their marketing authorizations for an EU without the UK.
A MAH may have to move from the UK to another country in the new EU. That may lead to a delay in production of relevant medicines.
Changes at the latest by December 2020.

Options – where available – include switching patients to other medicines with similar efficay and safety profiles. Additional burden of falsified medicines regulations coming at a difficult time.
Other topics included updates on electronic prescribing information, progress of the joint working parties topic group on Digital Media for Health. 

Regulatory support for development of orphan medicines: virtual workshop from the European Medicines Agency

A live online event from the European Medicines Agency on 30 November combined short talks with Q & A sessions and was intended to encourage early and efficient interactions with  regulators by highlighting pre-marketing support in medicine development for treating rare diseases.

The meeting aimed in particular to explain existing tools relevant to early product development strategy. 

These include:​

• orphan designation;
• protocol assistance;
• the PRIority MEdicines (PRIME) scheme.

Stakeholders were given an opportunity to express their views in relation to early medicine development and regulatory interactions. ​

The workshop was targeted at small to medium enterprise medicine developers, academia, patients, healthcare professionals and European Reference Networks (ERNs), often at the forefront of medicine development to treat rare and neglected diseases.

High level points include:

There are estimated to be 6-8000 orphan conditions of which around half concern diseases with an incidence of less than 1 in 10000.

183 orphan medical products have been registered in the EU since 2000. ~120 of these have active orphan status for treating ~130 orphan diseases ie several have indications for treating more than one disease.

Around 2 in 3 orphan products are based on conventional chemical treatments and 1 in 3 involve advanced therapeutic approaches.

The EMA supports SMEs and Academia in orphan drug development through a dedicated contact point, regulatory, administrative and procedural support and engaging with EU bodies and industry stakeholders.

Of the ~2000 SMEs registered with the EMA, 23% are working on orphan medical products.

A video recording will be available after the event on the EMA website.

Raising awareness to combat antimicrobial resistance: European Antibiotic Awareness Day

European Antibiotic Awareness Day EAAD was held on 18 November 2020 with activities taking place during that week. As in previous years, the European Medicines Agency (EMA) actively contributed to raising awareness about Antimicrobial Resistance (AMR) and how to limit it by publishing a set of infocards, developed to reinforce global cooperation to combat AMR.

EAAD is an annual European Union initiative to raise awareness of antimicrobial resistance as an increasing global public health threat and to promote the prudent use of antibiotics.

‘Tackling antimicrobial resistance is a global challenge and a high priority for EMA and the European medicines regulatory network. We all have a role to play in addressing this challenge: regulators, governments, companies through development of new innovative antibiotics, but also healthcare professionals and patients by making sure they prescribe and use antibiotics wisely and responsibly’ said Emer Cooke, EMA’s Executive Director.

To mark EAAD, the EMA launched a social media campaign to highlight the importance of using antibiotics prudently.

A set of info-cards focuses on what patients, healthcare professionals, veterinarians, health-leaders, journalists and the pharmaceutical industry in their respective roles can do on a daily basis to make sure that these important medicines are used wisely.

Antimicrobial resistance occurs when bacteria and other microorganisms change over time and develop resistance to medicines. As a result, antibiotics and other antimicrobial medicines become less effective. This makes infections harder and harder to treat. A prudent use of antibiotics helps slow the process and ensure that treatments continue to be available to treat common and emerging infectious diseases.

For more information on the EMA’s role in the global response to antimicrobial resistance, see Antimicrobial resistance.

You can see examples of the cards below. The full set of these infocards is downloadable on this link. 

 

 

European Medicines Agency to hold a public update on COVID-19 vaccines on 11 December

EMA will organise a public meeting on 11 December 2020 to inform European citizens about the EU regulatory processes for the approval of COVID-19 vaccines and the Agency’s role in their development, evaluation, approval and safety monitoring.

The COVID-19 pandemic is an unprecedented global crisis, with devastating health, social and economic impact. Safe and effective vaccines for COVID-19 are urgently needed to respond to this crisis and reduce its effects.

Together with the European medicines regulatory network, EMA is supporting the development of COVID-19 vaccines and has taken steps to speed up the evaluation processes for these vaccines. The Agency and its partners are doing so while ensuring that the same high regulatory standards for quality, safety and efficacy are being applied to COVID-19 vaccines.

The public meeting will inform citizens about EMA’s role in the pandemic and of EU regulatory procedures. It will also give the opportunity to the public and stakeholder groups to speak and share their needs, expectations and any concerns, that will be considered by EMA and the European medicines regulatory network in the decision-making process.

The EMA will publish the list of speakers who will make an intervention in advance of the event.

The public meeting will be broadcast live and will be open to all citizens. In addition to the selected list of speakers, during the meeting there will be a mailbox open via EMA’s website for the public to make comments.

The agenda and all information related to the event are available on the EMA website event page.

Please check EMA’s dedicated webpage on COVID-19 for the latest updates.

Updates from the European Medicines Agency re Covid-19: advice to continue use of ACE inhibitors and ARBs

27.3.20: Briefing from the European Medicines Agency

EMA reports that it is aware of recent media reports and publications which question whether some medicines, for instance angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs, or sartan medicines), could worsen coronavirus disease (COVID-19). ACE inhibitors and ARBs are most commonly used for treating patients with high blood pressure, heart failure or kidney disease. 

The EMA has providing the following advice from its Public and Stakeholders Engagement Department.

"It is important that patients do not interrupt their treatment with ACE inhibitors or ARBs and there is no need to switch to other medicines. There is currently no evidence from clinical or epidemiological studies that establishes a link between ACE inhibitors or ARBs and the worsening of COVID-19. Experts in the treatment of heart and blood pressure disorders, including the European Society of Cardiology, have already issued statements along those lines. To gather more evidence, EMA is proactively reaching out to researchers working to generate further evidence in epidemiological studies.

As the public health crisis rapidly extends across the globe, scientific research is ongoing to understand how the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reproduces in the body, interacts with the immune system and causes disease, and whether ongoing treatment with medicines such as ACE-inhibitors and ARBs could impact the prognosis of COVID-19.

The speculation that ACE-inhibitors or ARBs treatment can make infections worse in the context of COVID-19 is not supported by clinical evidence. These medicines work by affecting the renin-angiotensin-aldosterone system (RAAS). Because the virus uses a target called angiotensin converting enzyme 2 (ACE2), which is part of this system, to enter human cells, and the medicines can increase ACE2, one of the suggestions among others is that they could also increase virus activity. However, the interactions of the virus with the RAAS in the body are complex and not completely understood.

EMA is monitoring the situation closely and is collaborating with stakeholders to coordinate epidemiological studies on the effects of ACE inhibitors and ARBs in people with COVID-19.

EMA is helping to coordinate urgent ongoing research and is fully committed to keep the public up to date with any development in this field. EMA is also aware of reports questioning whether other medicines such as corticosteroids and non-steroidal anti-inflammatories (NSAIDs) could worsen COVID-19, and has recently issued a communication on NSAIDs medicines. It is important that patients who have any questions or are uncertain about their medicines speak to their doctor or pharmacist and do not stop their regular treatment without speaking to their healthcare professional first.

Medicines should be prescribed and used in line with clinical judgement, taking due note of any warnings and other information provided in the summary of product characteristics (SmPC) and thepackage leaflet, as well as guidance issued by the WHO and relevant national and international bodies.

Within the EU medicines regulatory network, evidence on the safe use of medicines is reviewed as it emerges. Any new advice that arises is disseminated appropriately through EMA and national competent authorities.

EMA will provide further information as appropriate.

This information and related content are published here. Please check EMA’s dedicated webpage on COVID-19 for the latest updates."