Mediaboss Marketing

The Court of Justice of the European Union (CJEU) clarified the definition of a prohibited defeat device in a series of recent rulings, limiting their use to when only immediate risks of damage are present. This report analyzes testing data and examines market surveillance interviews to determine how many vehicle models likely have defeat devices under the CJEU definition. Results are analyzed by vehicle model and engine family against emission thresholds developed in this report which identify if a prohibited defeat device is likely or almost certainly present. These thresholds are based on expected engine behavior and testing data from other vehicle groups.

Suspicious NOx emission levels were found in 77%100% of tests and vehicle averages, indicating the likely use of a prohibited defeat device. Of 1,400 total tests conducted under controlled settings by government authorities, 85% of tests on Euro 5 vehicles and 77% of tests on pre-RDE Euro 6 vehicles exceed the suspicious emissions threshold. Similar rates are observed for government tests conducted under real-world conditions. Results from independent real-world testing show that up to 100% of vehicle model averages exceed the suspicious threshold.

Extreme NOx emissions were found in 40%75% of tests and vehicle averages, indicating that a prohibited defeat device is almost certainly present. Approximately 42% of the 1,400 official government tests under controlled settings exceed the extreme threshold. Real-world testing by government authorities and independent bodies shows similar or higher rates of extreme emissions. Remote sensing data show that approximately 75% of engine family averages exceed the extreme threshold.

Over 200 unique vehicle models show high NOx emissions above the suspicious threshold and over 150 unique vehicle models show NOx emissions above the extreme threshold. Nearly all vehicle models tested by official government authorities show suspicious emissions in at least one test, and nearly 70% of vehicle models showed extreme emissions in at least one test.

Fact sheets: In English, Auf Deutsch, En Franais, In Italiano, En EspaolBlog postPress release

Read this article:
Reassessment of excess NOx from diesel cars in Europe following ... - International Council on Clean Transportation

Fiam, who will meet with Prime Minister Anthony Albanese in Canberra on Wednesday, acknowledged her idea was very contentious but said it was time to discuss how to deepen integration in the Pacific, a region she described as the epicentre of contemporary global geopolitics.

Prime Minister Anthony Albanese greets Samoa Prime Minister Fiam Naomi Mataafa at the Pacific Islands Forum last year. AFP.

Regarded as one of the most senior Pacific leaders, Fiam was tight-lipped on whether her nation supported Australias plan to acquire , saying the issue was none of my business.

Fiam said she had recently returned from Europe, where the common market allows the free movement of goods, capital, services, and people across national borders.

I think we need to explore that in the Pacific, Samoas first female prime minister said at an event hosted by the Lowy Institute at Old Parliament House.

Fiam said she raised the idea at last months Pacific Island Forum and Foreign Minister Penny Wong, who was representing Australia at the event, didnt say anything.

But the Deputy Prime Minister of New Zealand, who is part Samoan and part Tongan, said, Oh, but all other people in the islands will want to come and live in New Zealand and Australia.

Fiam said many people would assume this.

But you might think also that if we have easy access, people can just come do their business, visit their relatives, go on holiday in New Zealand and Australia, but go back home and not have such a difficult time coming into Australia or New Zealand, she said.

Pat Conroy, the Minister for the Pacific, said the government already had a strong commitment to promoting mobility in the region, including the creation of a green card-style system to bring 3000 Pacific workers into the country every year.

With China and the United States jostling for influence in the region, Fiam said leaders of larger nations needed to be more respectful of their Pacific counterparts.

I feel I need to be very frank and say that in the Pacific, we feel our partners have fallen short of acknowledging the integrity of Pacific leadership, she said.

Such acknowledgements can simply be in the form of information sharing and open consultation.

Fiam said the shift in global and regional geopolitics is creating an increasingly complex and crowded region that places the Pacific at the epicentre of contemporary global geopolitics.

Fiam said Pacific leaders did not necessarily accept or understand the concept of the Indo-Pacific, which countries such as Australia and the US increasingly use to frame discussions about the region.

The Pacific Islands were never consulted around that new narrative, or had a discussion around it, she said.

Given that we occupy a very large space of one of those oceans, one might have thought that having some input from the Pacific island might have been a good idea as we moved into that new narrative, but, you know, I think we were quite used to it.

Fiam avoided either endorsing or criticising Australias nuclear-powered submarine plan, saying this is how Australia sees its role in the security aspects of the region, and we understand that.

But she was grateful to receive a briefing from Australian officials on the matter.

There is a strong opposition to nuclear power in the Pacific Islands, after the region was used as a testing ground for nuclear weapons by the US and other nations in World War Two.

Fijian Prime Minister Sitiveni Rabuka said following a visit from Prime Minister Anthony Albanese last week that and Albanese had assured him Australias submarine push would not undermine the Treaty of Rarotonga, which declares the South Pacific a nuclear weapons-free zone.

Cut through the noise of federal politics with news, views and expert analysis from Jacqueline Maley. Subscribers can sign up to our weekly Inside Politics newsletter .

Continued here:
Pacific leader calls for European Union-style free movement across the region - Sydney Morning Herald

The Government of Mozambique and the European Union signed a 4,5 year agreement worth EUR 10 million to expand climate finance in the country through the Improving Local Climate Resilience in Mozambique (MERCIM) Program, technically supported by the United Nations Fund for Capital Development (UNCDF).

The announcement was made during the MERCIM Program Steering Committee this Friday, March 17, after a capitalization workshop on good practices to share learnings about the capacity of subnational governments to reduce climate vulnerability through locally led action.

The MERCIM Program was created in 2019 by the Ministry of Land and Environment, aimed at four districts (Memba, Mopeia, Morrumbala and Mossuril), in the Provinces of Zambezia and Nampula, selected in consultation with the Government of Mozambique and its development partners. With its expansion, MERCIM+ now covers 10 districts in four provinces, including Cabo Delgado, Nampula, Sofala and Zambezia.

Nature continues to test our response and preparedness capabilities against extreme weather events, said Permanent Secretary of the Ministry of Land and Environment (MTA), Ms. Emilia Fumo. We feel firsthand what the impacts of climate change are and a clear example of this is cyclone Freddy that is currently hitting the country and cyclone Gombe last year, both exactly in the provinces where we have implemented MERCIM, she continued.

According to MTA's Permanent Secretary, what was done during the last years of the program's implementation prevented the loss of lives and essential infrastructure, as well as the continued provision of essential basic services.

We need to strengthen the capacity of local governments to adapt to the changing climate so that the impact of extreme weather events is less and less; And that means expanding the MERCIM project to the entire country, said Ms. Emilia Fumo.

Mozambique is among the top three countries in Africa most vulnerable to climate change. In the last decade, Mozambique has been hit by six cyclones and two tropical storms, impacting around four million people. Cyclone Freddy is the latest of these, affecting around 800,000 people.

During her speech, the Head of Cooperation of the European Union in Mozambique, Ms. Paula Vazquez Horyaans, stated that supporting adaptation to the impact of climate change is a key priority for the European Union.

We have supported the government in implementing its environmental and climate policies and programs since 2010 through various initiatives; It is our intention to maintain this role in the future, Ms. Paula Vazquez Horyaans, Head of European Union Cooperation in Mozambique.

For Mrs. Horyaans, support for the implementation of the Nationally Determined Contribution of Mozambique assumes a central place in the multi-annual cooperation program of the European Union with the country, in which MERCIM holistically supports the three levels of government to implement climate adaptation strategies and actions for the benefit of all Mozambican men and women.

Strengthening the capacity of local governments

MERCIM uses UNCDF methodologies that strengthen the capacity of local governments to improve the delivery of climate-resilient basic services to communities and to enhance decision-making processes based on local knowledge.

This means providing capacity building and technical assistance to governments so that communities can actively participate in planning, budgeting, and other local governance processes in a gender-sensitive manner.

To do this, it uses a participatory, bottom-up approach to challenges, which through the use of local consultative councils ensures essential buy-in at the local level. First, local communities are engaged in what they consider to be their greatest needs, proposals are forwarded to local and then provincial administrations.

The inclusive and participatory approach has been central in the implementation of MERCIM in all districts, both in deciding on climate resilient investments, but also in integrating climate change adaptation into local budgeting and financing instruments and planning, said Ramon Cervera, UNCDF representative in Mozambique.We as UNCDF are here to technically support capacities that already exist at a decentralized level and use the knowledge of local communities to fight climate change, continued Ramon Cervera.

MERCIM uses channels climate finance to local government authorities for locally led adaptation, usingPerformance Based Climate Resilience Grants. Such grants provide additional funds to cover the extra expenses of making local investments climate resilient and include minimum conditions and performance measures that inform subsequent PBCRG allocations.

Since the inception of MERCIM, 26 activities and resilient infrastructure have been fully funded, with 18 completed and accounted for in target districts. All these infrastructures and investment projects were identified, prioritized, selected, and approved by the population of the districts together with local governments, taking into account the existing Local Adaptation Plans - a key tool of the National Strategy on Climate Change Adaptation and Mitigation.

Altogether, through MERCIM, 18 Local Adaptation Plans were created in Nampula and Zambezia, covering all districts of both provinces. Throughout Mozambique, there are 33 Local Adaptation Plans, including 30 funded by the European Union and all technically supported and carried out through the partnership of the Government of Mozambique with UNCDF.

Link:
Mozambique Expands Locally-Led Climate Resilience, with support from the European Union - ZAWYA

This approval makes the drug the first and only targeted medicine indicated to treat this population of children in Europe and the United States.

The European Commission (EC) has approved Dupixent (dupilumab) in the European Union to treat severe atopic dermatitis in children six months of age to five years of age who are candidates for systemic therapy. This approval makes the drug the first and only targeted medicine indicated to treat this population of children in Europe and the United States.

Dupixent is a subcutaneous injection at different injection sites and is intended for use under the guidance of a healthcare professional. It can be given in a clinic or at home by self-administration after training by a healthcare professional.

The approval is based on data from a Phase III trial that evaluates Dupixent every four weeks plus low-potency primarily topical corticosteroids (TCS) or TCS alone in 162 children between six months of age to five years of age with moderate-to-severe atopic dermatitis. The medicine improved skin clearance and reduced overall disease severity and itch at 16 weeks compared to placebo in the overall enrolled population.

In addition, Dupixent improved sleep quality, skin pain, and health-related quality of life compared to placebo in both the overall and severe populations, and the long-term efficacy data showed the clinical benefit at 16 weeks was sustained through 52 weeks, according to the Sanofi.

Common side effects across all indications include injection site reactions, conjunctivitis allergic, arthralgia, oral herpes, and eosinophilia.

Source: Sanofi

Read this article:
European Commission Approves Dupixent as First, Only Targeted ... - BioPharm International

EMA has published a report summarising the mid-term achievements of itsRegulatory Science Strategy (RSS) to 2025. The report provides an overview of the main deliverables achieved between March 2020 and December 2022 across the human and veterinary areas.

The achievements highlighted in this report demonstrate that we have made considerable progress in advancing regulatory science to build a more adaptive regulatory system that encourages innovation in human and veterinary medicines, said Emer Cooke, EMAs Executive Director.

The mid-term report highlights achievements for the top five human and top three veterinary recommendations thought to deliver the most significant change over the course of the five-year strategy, according to an extensive stakeholder consultation process that took place with EMAs scientific committees, stakeholders and EU regulatory partners.

In thehumandomain, progress was made in several areas, including:

In theveterinarydomain, progress was made in several areas, including:

The report also highlights achievements for thehumanandveterinary medicines strategies. Links are included in the report to detailed information on goals, core recommendations and underlying actions in these areas.

Work will continue at pace through 2023-2025 to deliver the strategic goals to their fullest potential.

We will seek opportunities to further progress delivery of the Regulatory Science Strategy to 2025, and the broaderEuropean medicines agencies network strategy to 2025, as we emerge from a long period of business continuity. This work will be crucial to evolve the networks capability to engage with and enable innovative science and technology within the current pharmaceutical framework and pave the way for the legislative review, added Ms Cooke.

A final report on the regulatory science strategy will be published in 2026, once the strategy has been completed.

EMA published its Regulatory Science Strategy to 2025 in March 2020. The strategy was developed in 2018 and 2019 in consultation with a wide range of stakeholders and provides a plan for advancing regulatory science over a five-year period.

The motivation behind the strategy was the recognition that the pace of innovation had accelerated dramatically in recent years. As part of their mission to promote and protect human and animal health, regulators needed to be ready to support the development and assessment of ever more complex medicines that increasingly deliver healthcare solutions by converging different technologies.

Furthermore, the advent ofBig data opened up new sources of information on the use of medicines in healthcare settings. Regulators needed to take action to address the challenges arising from collecting and processing these data from patients.

The COVID-19 pandemic also underlined the need for rapid and close engagement of all stakeholders and partners involved in the development and supervision of medicines in the European Union and globally, which is one of the fundamental principles of this strategy.

Note

Regulatory sciencerefers to the range of scientific disciplines that are applied to the quality, safety and efficacyassessment of medicinal productsand that inform regulatory decision-making throughout the lifecycle of a medicine. It encompasses basic and applied biomedical and social sciences and contributes to the development of regulatory standards and tools.

Read more from the original source:
Advancing regulatory science in the EU mid-point report published ... - European Medicines Agency |