Tag: european medicines agency

  • Second vaccine authorised by the EU

    Second vaccine authorised by the EU

    Just a few hours after the European Medicines Agency issued its recommendation, the European Commission on Wednesday authorised the second Covid-19 vaccine, namely the one produced by the US company Moderna. In fact, the EC has already ordered 160 million dozes of the vaccine, on behalf of the EU member countries. The vaccine is to be used for people over 18 and, just like the one produced by Pfizer/BioNTech, will be administered in two dozes.

    On its website, the European Medicines Agency gives assurances that the vaccine meets all EU safety standards and promises to continue to monitor its efficacy. Moderna, too, says it will monitor the effects of the vaccine in the following two years. According to clinical trials on some 30,000 subjects, aged 18 to 94, the vaccine’s efficiency is 94.1%. It is based on the messenger-RNA technology, just like the one made by Pfizer/BioNTech, which prepares the body to defend itself if it contracts the SARS-CoV-2 virus. After vaccination, the body produces a protein in the coronavirus and, subsequently, antibodies. After a short while the protein disappears, but the body will recognise it and defend itself.

    While waiting for the first Moderna vaccines, Romania has been receiving those from Pfizer/BioNTech. The third tranche of 150,000 dozes arrived on Wednesday. Authorities say that the immunisation process is unfolding in keeping with the national strategy developed to this end, and medical staff are being immunised in the first stage.

    In another move, Romania has joined another 12 EU member countries and, in a joint letter to the European Commission, called for support for the Eastern Partnership and Western Balkan states, countries that are poorer or do not have a clear calendar for national vaccination campaigns.

    The Union will not be safe from Covid-19 until the countries it neighbours are able to recover from the pandemic too, the document reads. Romania has already sent to the neighbouring Republic of Moldova the first batch of medicine and medical equipment to fight the pandemic from the support package announced by Romania’s President Klaus Iohannis on the occasion of his recent visit to Chisinau. He also promised 200,000 doses of vaccine for the Republic of Moldova. (M. Ignatescu)

  • November 21, 2017

    November 21, 2017


    PATRIOT – The bill on the purchase of Patriot missile defense systems from the US has been fully endorsed today by the Romanian Chamber of Deputies, which is the decision making forum in this matter. Previously, the bill was endorsed by the Senate. Romania wants to purchase seven Patriot systems, whose total value stands at some 3.9 billion dollars. The first system, costing 765 million dollars is to be purchased by the end of the year.



    MOTION – The Democratic Union of Ethnic Hungarians in Romania has decided to abstain from voting on the no-confidence motion filed by the right-wing opposition against the Government formed by the Social Democratic Party and the Alliance of Liberals and Democrats in Romania. The leader of the union Kelemen Hunor has stated that he agrees with some of the statements included in the motion, but has blamed the initiators for not providing alternatives to the current prime-minister and his governing programme. Signed by senators and deputies members of the National Liberal Party, the Save Romania Union and the Peoples Movement Party, the motion accuses the Executive that, through its policies, has deeply disturbed Romanian economy. In response, the Prime Minister Mihai Tudose has stated that, thanks to the latest fiscal reform, more money will get to the state budget and to the pension fund and companies will benefit from simplified procedures.



    EMA/EBA – Gathered in Brussels on Monday, the EU foreign ministers decided that the European Banking Authority (EBA) would have its headquarters in Paris. Also, Amsterdam will host the European Medicines Agency (EMA). The EU officials have chosen the Dutch capital through a competition in which Bucharest ran too. The two institutions, currently based in London, will be relocated after Brexit, in March 2019. EMA has 900 employees and supervises the safety of medicines sold on a market of more than 500 million consumers. As regards EBA, the French president Emmanuel Macron has stated that choosing Paris is a recognition of Frances attractiveness and commitment. EBA regulates and supervises the banking system across the EU.



    GERMANY – Consultations have started today in Germany on ways to exit the political crisis triggered by the Conservatists, the Liberals and the Greens failing to reach consensus on the formation of the new Government. The president of the country Frank Walter Steinmeier, who, according to the Constitution, must manage the crisis, has announced his intention to hold talks with all the political parties that could be part of the Government headed by Angela Merkel. We recall that her party won the legislative elections of September 24th. Steinmeier has excluded the participation of the far-right Alternative for Germany and the far-left Die Linke parties, as Angela Merkel refuses to engage in a dialogue with them. Also, the president has rejected the idea of early elections. According to the outcome of the September elections, Angela Merkel can only head a coalition government, as she excludes the alternative of a minority executive.



    GAUDEAMUS – For the first time in its history, the GAUDEAMUS International Book Fair, organised this year by Radio Romania between the 22nd and the 26th of November, will have as the guest of honour not a country, but a Union, namely the European Union, through the Representation of the European Commission in Romania. This years edition is special, as it marks 60 years since the signing of the Roma Treaty, 30 years since the launch of the Erasmus programme and also 10 years since Romania joined the European Union. Under the motto “unity in diversity”, the European Union encourages people to discover and explore the rich cultural heritage of the old continent. This years edition will enjoy the participation of 300 exhibitors and will host more than 800 events.



    TOURISM – According to official data, Romanian tourism has grown by 10% in 2017 and the total number of tourists choosing Romania as one of their holiday destinations is likely to exceed 12 million this year, a value that has not been reached since 1990. The announcement was made by the first-vice president of the National Association of Travel Agencies Adrian Voican. He has stated that, in the first nine months of the year, the number of Romanians who chose Romania as a tourist destination increased by one million, reaching 9.5 million. Also, the number of foreign tourists is expected to exceed 2.6 million this year. Spa tourism has become a particular attraction, and the sales on this segment have doubled. (Translated by Mihaela Ignatescu)




  • 9 September, 2017 UPDATE

    9 September, 2017 UPDATE

    EU
    agency relocation.
    Romania has officially launched its bid to host the European
    Medicines Agency currently based in London and which will be relocated after
    Brexit. The healthcare minister Florian Bodog says Romania has a 15-year
    experience in the field and skilled labour in the form of 18,000 highly
    qualified researchers. France, Sweden, Denmark, Hungary and Bulgaria also
    offered to host the European Medicines Agency. The European Commission will
    assess the bids by September 15 before announcing its final decision on the
    sidelines of the General Affairs Council in November. The European Medicines
    Agency is a decentralised agency of the European Union responsible for the scientific evaluation, supervision and safety monitoring of medicines in
    the EU.




    Hungary-Romania. Hungary has reiterated its decision not
    to support Romania’s and Croatia’s accession to the Organisation for Economic
    Cooperation and Development (OECD). The reasons given are a move by the
    Romanian authorities to close the Roman-Catholic Theological College in Targu
    Mures in Romania’s case and a dispute over an investment of the Hungarian
    company MOL in Croatia in the latter case. The activity of the
    Hungarian-language school in Targu Mures was suspended because the institution
    no longer existed following a final court ruling. The foreign ministry in Bucharest
    said any educational institution in Romania must respect, without exception,
    the Romanian legislation, which does not discriminate on ethnic and religious
    grounds. Any attempt to present the situation at the school in Targu Mures as a
    failure to respect the rights of ethnic minorities is inaccurate, the Romanian
    authorities also said, pointing out that there are many educational
    institutions in Romania that demonstrate the Romanian state ensures the right
    of the ethnic Hungarian minority to learn and be taught in its mother
    tongue.




    Ethnic minorities. The Romanian authorities have again
    called on Ukraine to re-examine its new education law that drastically
    restricts education in the mother tongue for ethnic minorities. Romania’s
    foreign minister Teodor Melescanu said after a telephone conversation with his
    Ukrainian counterpart Pavlo Klimkin that the situation can only be solved
    during a meeting between the education ministers of the two states. Under the
    legislative changes adopted by the Ukrainian Parliament, teaching in high
    schools and universities is to be done only in the state language, while
    teaching in the mother tongue of ethnic minorities will only be provided in
    nurseries and primary schools. Almost half a million ethnic Romanians live in the
    neighbouring Ukraine, mostly in the eastern Romanian territories annexed in
    1940 after an ultimatum by the former Soviet Union and inherited by Ukraine as
    a successor state in 1991.




    First aid. The Romanian Red Cross on Saturday
    held the biggest free first aid course in the country on World First Aid Day.
    1,000 people from 41 county capitals and Bucharest’s six sectors took part in
    the 6-hour course, being taught different first aid techniques. The theme of
    the course was how to provide first aid in the case of domestic accidents that
    may cause injuries and even death.

    Migrants. Two boats carrying migrants were intercepted by the
    Romanian Coast Guard while drifting close to the Black Sea shores. One of the
    boats was guided towards Bulgaria, while the second was escorted to the port of
    Mangalia. The authorities requested that a special tent be put in place for the
    migrants by the Inspectorate for Emergency Situations.




    US Open. The
    Romanian-Dutch pair Horia
    Tecau and Jean-Julien Rojer won the men’s doubles title at the US Open,
    defeating the all-Spanish pair Feliciano Lopez and Marc Lopez in straight sets.
    This is Tecau and Rojer’s second Grand Slam title after winning their first at
    Wimbledon in 2015. Tecau also played the mixed doubles semifinals together with
    the American player Coco Vandeweghe, but lost to the Swiss-British pair Martina Hingis and Jamie Murray.



  • 9 September, 2017

    9 September, 2017

    EU
    agency relocation.
    Romania has officially launched its bid to host the European
    Medicines Agency currently based in London and which will be relocated after
    Brexit. The healthcare minister Florian Bodog says Romania has a 15-year
    experience in the field and skilled labour in the form of 18,000 highly
    qualified researchers. France, Sweden, Denmark, Hungary and Bulgaria also
    offered to host the European Medicines Agency. The European Commission will
    assess the bids by September 15 before announcing its final decision on the
    sidelines of the General Affairs Council in November. The European Medicines
    Agency is a decentralised agency of the European Union responsible for the scientific evaluation, supervision and safety monitoring of medicines in
    the EU.




    Hungary-Romania. Hungary has reiterated its decision not
    to support Romania’s and Croatia’s accession to the Organisation for Economic
    Cooperation and Development (OECD). The reasons given are a move by the
    Romanian authorities to close the Roman-Catholic Theological College in Targu
    Mures in Romania’s case and a dispute over an investment of the Hungarian
    company MOL in Croatia in the latter case. The activity of the
    Hungarian-language school in Targu Mures was suspended because the institution
    no longer existed following a final court ruling. The foreign ministry in
    Bucharest said any educational institution in Romania must respect, without
    exception, the Romanian legislation, which does not discriminate on ethnic and
    religious grounds. Any attempt to present the situation at the school in Targu
    Mures as a failure to respect the rights of ethnic minorities is inaccurate,
    the Romanian authorities also said, pointing out that there are many
    educational institutions in Romania that demonstrate the Romanian state ensures
    the right of the ethnic Hungarian minority to learn and be taught in its mother
    tongue.




    Commemoration. A massacre
    committed on September 9th, 1940 by the troops of Horthyst Hungary
    is commemorated today in the village of Treznea, in north-western Romania.
    After the enforcement of the Vienna Award, by which Nazi Germany and fascist
    Italy forced Romania to cede northern Transylvania to Hungary, the Hungarian
    troops killed hundreds of ethnic Romanians. 86 people were killed Treznea and
    157 in Ip. A similar massacre was committed on the 14th of October
    1944 in Moisei, when 29 ethnic Romanians were killed.




    Ethnic minorities. The Romanian authorities have again
    called on Ukraine to re-examine its new education law that drastically
    restricts education in the mother tongue for ethnic minorities. Romania’s
    foreign minister Teodor Melescanu said after a telephone conversation with his
    Ukrainian counterpart Pavlo Klimkin that the situation can only be solved
    during a meeting between the education ministers of the two states. Under the
    legislative changes adopted by the Ukrainian Parliament, teaching in high
    schools and universities is to be done only in the state language, while
    teaching in the mother tongue of ethnic minorities will only be provided in
    nurseries and primary schools. Almost half a million ethnic Romanians live in
    the neighbouring Ukraine, mostly in the eastern Romanian territories annexed in
    1940 after an ultimatum by the former Soviet Union and inherited by Ukraine as
    a successor state in 1991.




    US Open. The
    Romanian-Dutch pair Horia
    Tecau and Jean-Julien Rojer won the men’s doubles title at the US Open,
    defeating the all-Spanish pair Feliciano Lopez and Marc Lopez in straight sets.
    This is Tecau and Rojer’s second Grand Slam title after winning their first at
    Wimbledon in 2015. Tecau also played the mixed doubles semifinals together with
    the American player Coco Vandeweghe, but lost to the Swiss-British pair Martina Hingis and Jamie Murray.




    Boxing. The Romanian boxer
    Ronald Gavril was defeated by the American boxer David Benavidez by a split
    decision in a match for the WBC super middleweight title held on Friday night
    in Las Vegas. Gavril thus missed the chance to become Romania’s fifth world
    champion in professional boxing after Mihai Leu, Leonard Doroftei, Lucian Bute
    and Adrian Diaconu.






    Festival. The George Enescu Festival has
    entered its 8th day. The highlights today are the concerts given by
    the Munich Philharmonic Orchestra conducted by Valery Gergiev and Camerata
    Salzburg conducted by Tiberiu Soare. The concerts are broadcast by Radio
    Romania’s music and culture channels.

  • 20 July 2017, UPDATE

    20 July 2017, UPDATE

    Visit.
    Romanian Prime Minister Mihai Tudose on Friday travels to the neighbouring
    Republic of Moldova, an ex-soviet state with a majority Romanian-speaking population.
    High on his agenda are talks with his Moldovan counterpart Pavel Filip and
    Parliament speaker Adrian Candu on stepping up bilateral cooperation as well as
    Bucharest’s support for the European progress of the Republic of Moldova. The
    Romanian Prime Minister’s agenda does not include talks with Igor Dodon, the
    Socialist pro-Russian president of the republic. This is Tudose’s second visit
    abroad since taking office at the end of June. He first travelled to Brussels
    last week, where he told EU officials that Romania has the huge task of
    ensuring Moldova’s pro-European course.

    European Medicines Agency. The Romanian government on Thursday finalised its bid
    for hosting the headquarters of the European Medicines Agency, which is
    currently based in London but which will be relocated after Brexit. The
    authorities say this is a big opportunity for Romania, and if, successful, the
    move would boost the country’s role and visibility in the European Union. The
    government has also announced that the healthcare minister Florian Bodog, the
    minister delegate for European Affairs Victor Negrescu and the president of the
    National Medicines and Medical Equipment Agency Nicolae Fotin will travel to
    London on Monday. The European Medicines Agency is a decentralised body of the
    European Union whose main responsibility is the protection of public health through
    the evaluation and supervision of medicines.

    Budget deficit. Romania reported a budget deficit of 3.2%
    of the GDP in the first quarter of 2017, the second highest in the EU and above
    the 3% target set by the government in Bucharest, according to Eurostat. Out of
    20 the EU states to provide data, only France has a higher budget deficit, with
    3.3%. If the budget deficit exceeds 3% in a given member state, the EU can
    launch the excessive deficit procedure. In the new governing programme of the
    ruling coalition in Romania, it is specified that all the measures envisaged by
    the executive will be taken in keeping with the criteria of the Maastricht Treaty,
    which provides for a budget deficit below 3% of the GDP and a public debt lower
    than 60%.




    Business.
    The number of new companies with foreign capital set up in Romania rose in the
    first quarter of the year by 9.34% as compared with the same period last year,
    to reach 2,938. Their number went up by 13% in June this year compared with
    June last year, to 532. 2016 saw the lowest number of new foreign capital
    companies in the last 18 years. The second best year after 1991 was 2007, when
    15,000 new such companies were created. The worst year was 1995, when only
    3,400 new foreign capital companies were created.




    Brexit. EU Brexit negotiator Michel Barnier said on
    Thursday that there was still a fundamental disagreement in the talks with the
    UK. The main problems are the rights of the EU citizens living in the UK and
    those of the British citizens in the EU, the financial details involved by
    Brexit and the Irish border. Barnier made these statements at a joint press
    conference with the UK Brexit secretary David Davis at the end of the second
    round of talks. The next meeting is scheduled for the end of August.





  • European issues on Romania’s agenda

    European issues on Romania’s agenda

    Last week, Romanias President Klaus Iohannis attended in Brussels the proceedings of the summer European Council and has returned home with what the media has already dubbed the future Cabinets “homework. The new government, the head of state has announced, will have to get an agreement that, after Brexit, Romania becomes host to the headquarters of the European Medicines Agency.



    It will be by no means a mere formality, as there are other countries competing, namely France, Sweden, Denmark, Hungary and Bulgaria. Moreover, London itself would like to remain host to the agency, even after the UK leaves the EU. Its not only about prestige, but also about concrete benefits, as the Agency is a decentralized body of the EU responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.



    Therefore, the agency conducts the scientific evaluation of all European requests for marketing medicines aimed to treat AIDS, cancer, diabetes, neuro-degenerative disease and rare diseases. Moreover, it monitors the safety of such drugs by means of a so-called pharma-vigilance network, and takes measures in case reports indicate major side effects. Also, the Agency stimulates innovation and research in the pharmaceutical sector and provides companies with scientific counselling and support to develop new products.



    At the Council, a call was made for launching a permanent structural cooperation process, under which European military missions and operations will be launched and defence capability will be created. The framework is flexible and allows the participation of all interested parties, including Romania. In the coming three months, the parties will have to develop together the participation criteria and commitment standards.



    As president Iohannis has stated, the new Government in Romania will have to focus, among other things, on reviving the Romanian defence industry, as it will be able to use resources provided by the new European Defence Fund. The head of state has announced that small and medium-sized enterprises have access to this fund too, and Bucharest is expected to come up with a list of projects aimed at helping develop the European defence capability.



    On Romanias behalf, president Iohannis pleaded for a tight security cooperation between all the EU members states. Also, he stood against what he called “a parallelism with NATO and encouraged the creation of community structures complementary to those of the North-Atlantic Alliance. (Edited by D. Vijeu)