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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

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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 |

MEPs Alex Agius Saliba and David Casa have protested about a lack of translators of Maltese at European Union meetings, insisting that the situation is unacceptable.

Agius Saliba said the latest case happened on Wednesday at a meeting of the European Parliament's employment committee on the subject of discrimination. Soon after he started to speak, in Maltese, he was cut off and told by an official that an interpreter was not available.

Agius Saliba obliged, but not before delivering a stern rebuttal to colleagues in the committee.

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This is happening continuously in this committee we have been complaining about this for a number of weeks now, he said.

Branding the lack of interpreters as discrimination against the Maltese language, Agius Saliba told officials he would continue in English, but would not be so accommodating in the future.

[It is] totally unacceptable I cannot speak as my colleagues do in an official language of the European Union today I will be making my intervention, but Im sorry, next time he said.

Agius Saliba noted that there were other Maltese representatives present for the meeting, including the EUs Commissioner for Equality Helena Dalli.

Fellow MEP David Casa (PN) joined Agius Saliba in denouncing the lack of interpretation at the committee meeting.

It is not acceptable that my colleague was unable to speak in Maltese during the hearing in committee, he said.

Casa agreed that Maltese interpretation should be available and said he had written to the EU about the issue.

The Maltese language is an official language of the European Union, just as French or German or Slovak or Greek. Maltese interpretation should be available in such meetings, Casa said.

As an official language of the EU, Maltese is meant to be accepted and interpreted in all official meetings. With 22 commission meetings taking place, often at the same time, however, a lack of interpreters can mean that not all 24 official languages are always able to be interpreted, an MEP told Times of Malta.

This was not the first time that the EU has come under fire for not providing sufficient interpretation services in Maltese.

In 2020, Labour MEP Alfred Sant complained that many freelance interpreters had been left out in the cold during the COVID-19 pandemic due to meetings taking place virtually, branding the lack of personnel manifestly unfair and unjust.

In 2005, former Labour MEP and later Prime Minister Joseph Muscat refused to continue addressing the European Parliament (EP) after he was informed no interpreters were present to translate his speech from the Maltese language.

This situation is not acceptable anymore. We either have our language as an official one with all its full rights or we have only an official language on paper, Muscat told the EP back in 2005.

According to the EUs language policy as found on the EP website, the EU has adopted a full multilingual language policy, meaning that all EU languages are equally important... every Member of the European Parliament has the right to speak in the language of his or her choice.

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Lack of Maltese interpreters in the EU 'totally unacceptable,' MEPs ... - Times of Malta

23 March 2023

Bergeson & Campbell

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On February 28, 2023, the European Chemicals Agency (ECHA) announced that it updated its recommendationsto improve Registration, Evaluation, Authorisation and Restrictionof Chemicals (REACH) registrations. According to ECHA, therecommendations are based on ECHA's findings from registrationdossier compliance checks and take recent changes to REACHinformation requirements into account. The recommendations focus onthe rules for using adaptations to assess the safety of chemicalswithout animal testing. ECHA states that they provide advice onread-across, covering considerations on structural similarity,defining substance groups, and predicting target substanceproperties. ECHA also provided information on adaptations based onexposure scenarios outlined in chemical safety reports. Accordingto ECHA, further advice addresses the requirements for mutagenicityinformation and chronic aquatic toxicity studies for poorly solublesubstances. ECHA recommends that companies review therecommendations to make sure their dossiers comply with REACH andensure the safe use of their chemicals.

ECHA also released statistics on its progress evaluatingregistered substances. In 2022, ECHA conducted 330 compliancechecks covering more than 2,300 registration dossiers andaddressing 295 substances. According to ECHA, 302 checks were fullcompliance checks, addressing all relevant endpoints of substancesof potential concern. They resulted in 277 draft decisions beingsent to companies, requesting more data to clarify long-termeffects on human health or the environment. ECHA adopted 252compliance check decisions together with European Union (EU) memberstates. ECHA states that these decisions addressed data gapsremaining after draft decisions and dossier updates. ECHA alsoadopted 169 testing proposal decisions addressing 347 informationrequirements for which testing was originally proposed byindustry.

ECHA follows up on information requests sent to companies tocheck whether the information provided by companies complies withREACH requirements. According to ECHA, in 2022, this was concludedfor 249 substances. In about 60 percent of the cases, companiesprovided the requested information. ECHA notified the remaining 40percent to EU member states for enforcement. ECHA notes that italso adopted nine substance evaluation decisions, requestingfurther information to assess the safety of substances of potentialconcern.

The content of this article is intended to provide a generalguide to the subject matter. Specialist advice should be soughtabout your specific circumstances.

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ECHA Updates Recommendations To Improve REACH ... - Mondaq News Alerts