New Guide on Biosimilar Medicines for Healthcare Professionals The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines. Biosimilars are biological medicines that are highly similar in all essential aspects to a biological medicine that has already been authorised. The objective of the guide is to provide healthcare professionals with reference information on both the science and regulation underpinning the use of biosimilars.
Earlier this month the European Commission, together with 14 partners from national and regional authorities, universities, knowledge centres, innovators and end-users, signed an Innovation Deal on water reuse. The Innovation Deal will focus on perceived regulatory barriers in relation to the recovery of costs for water services, discharge requirements for urban wastewater treatment, and responsibilities of end-users for water reuse. An Innovation Deal is a voluntary agreement aiming to bring together relevant national, local and EU regulatory bodies and other agents to help innovators overcome perceived regulatory barriers to innovation. The concept of Innovation Deals has been launched in the scope of the Commission’s Circular Economy package.
In 2016, the European Chemicals Agency (ECHA) focused its dossier evaluation activities on substances with the greatest potential to negatively affect people and the environment: substances produced in high volumes – over 100 tonnes per year – and with a potential concern. To encourage registrants to update their dossiers already before compliance checks or risk management actions take place, ECHA sent letters to the registrants of 270 substances of potential concern, highlighting the deficiencies in their dossiers. The Agency also regularly published a list of substances that may be chosen for compliance checks. If the companies do not react by the deadline stipulated by ECHA, their registration will be revoked. Source: https://echa.europa.eu/
71 small and medium-sized companies (SMEs) from 22 countries have been selected for funding in the latest round of the Horizon 2020 SME Instrument Phase 2. The total amount to be distributed between the SMEs working on 66 projects is €103.82 million. In this phase of the instrument, each project will receive up to €2.5 million (€5 million for health projects) to finance innovation activities. Funding under Phase 2 of the instrument allows companies to invest in innovation activities such as demonstration, testing, piloting, scaling up and miniaturisation, in addition to developing a mature business plan for their product. The companies will also benefit from 12 days of business coaching. Most projects are proposed by a single SME but some companies team-up to elaborate a project. The next cut-off for SME Instrument Phase 2 is on 6 April 2017. Source: http://ec.europa.eu/
Commissioner Carlos Moedas and Vice-President of the European Parliament Mairead McGuinness announced the four winners of the EU Prize for Women in a ceremony that took place recently in Brussels. The awardees were Ms Michela Magas, founder of Stromatolite, a UK Design Innovation Lab with a studio in Sweden; Ms Petra Wadström, founder of Solvatten, which produces a portable water purifier and water heater that are powered by solar energy; and Ms Claudia Gärtner, founder of microfluidic ChipShop, which provides “lab-on-a-chip” systems as miniaturised solutions for better diagnostics. The aim of the EU Prize for Women Innovators is to raise public awareness of the need for more innovation and more women entrepreneurs, to recognise the success of women in innovation and create strong role models. Source: http://europa.eu/
The New Plastics Economy initiative launched its latest report in January 2017 at the World Economic Forum Annual Meeting in Davos. Endorsed by 40+ industry leaders, it provides a global action plan to transition towards a plastics system that works, aligned with the principles of the circular economy. Source: http://www.newplasticseconomy.org/
The European Chemicals Agency (ECHA) has recently provided updated guidance giving advice on how to use non-animal test methods. The guidance takes into account the recently changed REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) information requirements, which made non-animal testing the default method for skin corrosion/irritation, serious eye damage/eye irritation and skin sensitisation. In addition, the guidance introduces a new possibility to use a weight-of-evidence approach for acute toxicity. Source: https://echa.europa.eu/
Earlier this month in a ceremony at the University of Leuven in Belgium, Carlos Moedas, European Commissioner for Research, Science and Innovation, delivered a €1 million Horizon Prize for Better Use of Antibiotics to a for a finger prick test that can diagnose in less than ten minutes a bacterial infection and identify if a patient can be treated safely without antibiotics. The easy-to-use test is expected to be available for patients by 2018. Source: http://europa.eu/
EFSA and the European Chemicals Agency (ECHA) have published an outline of the Guidance they are developing on how to identify substances with endocrine disrupting properties in pesticides and biocides.The Guidance will enable applicants and regulatory authorities to identify endocrine disruptors among chemical substances proposed as pesticides and biocides using hazard-based scientific criteria currently being finalised by EU Member States and the European Commission. A public consultation on the draft Guidance is scheduled for the summer of 2017. Source: http://www.efsa.europa.eu/
Enforcement authorities in the EU will inspect how safety information on hazardous chemicals is compiled, communicated in the supply chain and followed at workplaces. One of the objectives of this enforcement project is to ensure that workers handling hazardous chemicals, especially those dealing with substances of very high concern, receive sufficient and correct safety information. The project will also map how effectively extended safety data sheets are passed on and communicated all the way through the supply chain, i.e. from manufacturers of chemicals to the users. Source: https://echa.europa.eu/
The European Medicines Agency (EMA) will launch a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development path of biosimilar medicines. Through this new initiative, EMA aims to provide developers of biosimilars with advice on the studies/tests they should be conducting, on the basis of the quality, analytical and functional data they have already available for the medicine. Biosimilars are biological medicines developed to be highly similar to another biological medicine already authorised in the EU. The pilot is open to all companies seeking scientific advice for the development of a biosimilar medicine. Source: http://www.ema.europa.eu/
China 2015 Research and Innovation Observatory Report (RIO) explains recent policy reforms and laws aiming to accelerate innovation-driven growth and address major challenges in China’s innovation system. It examines the recent ‘Made in China 2025’ plan and an ongoing major reform, begun in 2015, towards greater independence, transparency and coordination of China´s many R&D funding programmes. The report also presents a mapping of areas for potential cooperation and a selection of key institutions in China is presented in the report to facilitate collaborations between EU and Chinese research organisations. Source: https://ec.europa.eu/
Earlier this month, the Joint Research Centre published the 2016 edition of the EU Industrial Research and Development (R&D) Investment Scoreboard analyses the 2500 companies investing the largest sums in R&D in the world in the fiscal year 2015/16. It comprises companies based in the EU (590), the US, Japan, China, Taiwan, South Korea, Switzerland and further 20 countries. This scoreboard shows significant worldwide rise of corporate R&D, driven by high-tech industries while revenues declined mostly due to low-tech sectors. In the EU chemicals sector, just one of the many sectors where chemistry is intensively used, the average private growth of investment in R&D was 7.1%. Source: http://iri.jrc.ec.europa.eu/
COSME, the EU programme for the Competitiveness of Enterprises and Small and Medium-sized Enterprises (SMEs) running from 2014 to 2020, has recently set up the Equity Facility for Growth (EFG). EFG is dedicated to investments in risk-capital funds that provide venture capital and mezzanine finance to expansion and growth-stage SMEs, in particular, to those operating across borders. It is expected that some 500 firms will receive equity financing through the programme, with overall investment reaching up to €4 billion. Source: http://ec.europa.eu/
These “use maps” help registrants to improve the quality of their registrations, in particular their exposure scenarios. The European downstream user industry has now started to publish sectoral use maps to help manufacturers and importers of chemicals register their substances. The first use maps for the adhesive and sealant industry; soap, detergents and maintenance products; and cosmetics are now available on the European Chemicals Agency (ECHA) website. The use maps have been developed by industry to enhance supply chain communication and improve the safe use of chemicals. Using a harmonised template, sectors representing downstream industry share with registrants how their companies use chemicals. Source: https://echa.europa.eu/
This web tool supports business stakeholders and policy makers at EU, national and regional level in the development of policies regarding advanced technologies in Europe. The new Key Enabling Technologies (KETs) Observatory website is now live. The improved site provides visitors with easier access to data on the deployment of KETs in Europe and worldwide and aims to nurture innovation strategies and smart specialisation in the area of KETs. The new interactive maps and charts allow users to easily extract and analyse data for a specific technology, country or region. Different indicators capture the performance of KETs at different stages of the value chain, from the invention of new technology (patents), to its application and use (production, trade and turnover). Source: http://ec.europa.eu/
The European Patent Office (EPO) is conducting a Pan-European survey in order to understand what kind of information supports an organisation’s innovation process. EPO offers inventors a uniform application procedure which enables them to seek patent protection in up to 40 European countries. Source: https://www.iprhelpdesk.eu/news/
Companies registering the same substance must work together to compile and share information on the uses, hazards and risks of their substance to demonstrate safe use. If new data involving animal testing needs to be generated, alternatives must always be considered first. All this information on the uses, hazards and risks should be reported in a registration dossier and submitted to the European Chemicals Agency (ECHA) by 31 May 2018.
Source: https://echa.europa.eu/
The European Medicines Agency (EMA) has improved its scientific guidelines for human and veterinary medicines on its website. EMA’s scientific guidelines help medicine developers prepare market authorisation applications for human and veterinary medicines. They provide advice to applicants, national competent authorities and other interested parties on the best or most appropriate ways to fulfil the obligations set out in European Union (EU) pharmaceutical legislation. Source: http://www.ema.europa.eu/ema/
The European Commission has published the report “Opportunity now: Europe’s mission to innovate “, that looks at how best to position Europe as a global pro-innovation actor. The report highlights that the European Institute of Innovation and Technology (EIT) “offers real added-value” and “inspires highly productive interaction between innovation hubs, stakeholders, start-ups and scale-ups. Thanks to this effective and constructive relationship, access to talent, knowledge and markets and support for new innovative business ventures is continuously fostered by the EIT and its Knowledge and Innovation Communities.” To date, the EIT Community has developed more than 900 business ideas and 200 innovative start-ups in the areas of climate, digitalisation, energy, health and raw materials. Source: http://eit.europa.eu/
The Commission implementing decision on Best Available Techniques (BAT) conclusions for the non-ferrous metals industries has now been published. BAT conclusions are the technical basis for competent authorities in EU countries to set permit conditions for the installations concerned, as stipulated by the Industrial Emissions Directive. BAT conclusions aim to achieve a high level of protection of the environment under economically and technically viable conditions. Non-ferrous metals and their alloy play a centre role in our society, particularly in the sectors of energy generation, computing, electronic, telecommunication and transport industries. Source: https://ec.europa.eu/
Earlier this year, the European Commission adopted legislation on the classification, labelling and packaging of substances and mixtures (the ‘CLP Regulation’). The CLP Regulation sets rules on the hazard classification of chemicals, how these hazards are communicated through labelling and how the chemicals are packaged. CLP labels provide important hazard information to consumers and workers through pictograms (in the shape of a red diamond), hazard and precautionary statements and other labelling elements. The 8th ATP to CLP entered into force on 4 July 2016. Application of the new rules becomes mandatory from 1 February 2018, although they can be applied voluntarily before this date. Source: http://ec.europa.eu/
SMEs and entrepreneurs from Bosnia and Herzegovina will now be able to participate in COSME, the Competitiveness of Enterprises and Small and Medium-sized Enterprises Programme, under the same conditions as their counterparts from EU Member States and other associated countries. COSME will support projects on a wide range of topics that include clusters, SME internationalisation, building entrepreneurship skills, tourism, reducing the administrative burden for companies and protection of intellectual property rights for companies operating in non-EU countries. It will help SMEs identify funding sources. Bosnia and Herzegovina is the tenth country outside the EU to join and contribute to the programme, after Iceland, Montenegro, the former Yugoslav Republic of Macedonia, Moldova, Turkey, Albania, Serbia, Armenia and Ukraine. Source: http://ec.europa.eu/
As part of the Skills Agenda for Europe, the Commission has published an ‘Entrepreneurship Competence Framework’ (EntreComp) to raise consensus about what entrepreneurship skills are.
This framework proposes a shared definition of entrepreneurship as a competence and aims to establish a bridge between education and work. The framework develops 15 competences along an 8-level progression model and proposes a comprehensive list of 442 learning outcomes. EntreComp can be used as a basis for the development of curricula and learning activities fostering entrepreneurship as a competence. Also, it can be used for the definition of parameters to assess learners’ and citizens’ entrepreneurial competences. Source: http://ec.europa.eu/
The update of the dossier submission and communication tool, REACH-IT, will be launched on 21 June. To manage the update, ECHA has closed the system one week before the launch, on 14 June at noon. The new REACH-IT will be simpler to use and more intuitive, which will particularly help small and medium-sized companies (SMEs) registering their chemicals for the last REACH registration deadline of 31 May 2018. Source: http://echa.europa.eu/
