Food and Drug Administration (FDA) Recognizes Quality of INFARMED Inspections

Food and Drug Administration (FDA) Recognizes Quality of INFARMED Inspections - 

 

The Food and Drug Administration (FDA), the drug regulatory body of the United States, acknowledged the capability and quality of the inspections carried out by INFARMED. This means that the FDA will stop conducting inspections in Portugal and will recognize the results associated with the INFARMED Good Manufacturing Practices inspections.

In addition to avoiding duplication of inspections, this recognition will contribute to increasing the volume of domestic exports to the United States. According to preliminary data for 2017, the value of exports of Portuguese companies to the United States was 55 million euros, which is the country that leads the national exports.

In a communication sent to the Board of Directors of INFARMED, the FDA noted that "Infarmed has the capability, means and procedures required to conduct good manufacturing practice (GMP) inspections that meet FDA requirements." The products to which this agreement applies are, inter alia, medicinal products for human use, biological medicines and medical gases.

 

Source: INFARMED website and author on September 18, 2018

Export of medicines worth 959 million euros to Portugal

Export of medicines worth 959 million euros to Portugal -  - 

 

There was a slight decrease in 2017 compared to the previous year, but it was the second best value since 2010. The United States, Germany and the United Kingdom are the main buyers.

Last year Portugal sold drugs worth 959 million euros. A slight decrease from the previous year, but still the second best value since 2010 (444 million euros). Without major fluctuations in recent years in the top ten of the major buying countries, the list is led by the United States, Germany and the United Kingdom.

The exported products are varied, between active substances, generic and branded drugs. There are drugs for diseases of the central nervous system, cardiac system, epilepsy, Parkinson's disease, to high levels of concentration of potassium in the blood, antibiotics, vaccines, among others.

According to data from the National Institute of Statistics, sent to the PUBLIC, since 2010 the route has always gone up and the sale of this type of products reached its best value in 2016, when exports were worth 1020 million euros. In that year, the United States represented close to 25% of the value of exports, followed by Germany (15.2%) and the United Kingdom (12.2%).

The provisional data for 2017 - year in which we sold to more than 140 countries - show a slight decrease of 6% compared to 2016. The top three of the buying countries remained unchanged, but the weight of the North American market decreased. This trend continued in the first seven months of this year, with exports to the US totaling around 55 million euros - 57.5% less than in the same period last year.

Preliminary data for the first months of this year show a decline in total exports compared to the same period last year: from 617 million euros to 493 million euros. In addition to the United States, sales to the Angolan market also contracted significantly (down 22.8%).

 

Produce more:

For the Portuguese Association of the Pharmaceutical Industry (Apifarma), this "slight fluctuation" in sales last year and apparent continuity this year "does not allow a tendency to reduce the value of exports". "In any case, the situation observed in countries like Angola, Brazil and Venezuela can justify some of the disturbance registered," admits the association.

Paulo Lilaia, president of the Portuguese Association of Generic and Biosimilars (Apogen), also does not point out concrete reasons, but stresses that "it is necessary to evaluate the exports of medicines produced in Portugal and those that are exported but are not produced in the country." "My perception is that the quantity and value of medicines produced here and exported continues to increase, which may have diminished are the medicines imported and then exported in which Portugal serves as a platform. What brings value and employment is what is produced in Portugal, "he says, noting that there are several companies that are producing more.

Joaquim Cunha, Executive Director of Health Cluster Portugal - a platform that has several health sector companies and academic institutions - reports that sales behavior was not the same during the seven months, with signs of recovery in the second quarter. Therefore, he believes that this year may close in line with 2017.

Import values have not fluctuated significantly in recent years. In 2017 Portugal imported medicines worth 1879 million euros. Germany, Spain and the United Kingdom were the countries we bought the most.

 

Work of "ant":

Medicines are the largest share of exports, but not the only one. Medical devices and consumable supplies, such as gowns, surgical fields, or compresses, also have important expression. "Exports will reach 300 million euros. It has always grown, in 2010 it was 150 million, "says Joaquim Cunha, who states that in all, in 2017, health will have meant a fit close to 1.4 billion euros and a weight around 3% of the total exports of goods.

Getting here, he adds, was a long work. "First of all. Ants work, persistence and resilience and the results are taking effect. Secondly, it became possible to pass on the health message as a strong driver of economic and social development and give visibility to the sector. "

Paulo Lilaia talks about AICEP support "so that international companies can make their investment" and support for national companies to enter the foreign market. Apifarma highlights the participation, for the first time, of Portuguese companies in the event CPhl North America 2018, which took place in April. In October they will be present in the European version that takes place in Spain.

"This work reinforces the commitment of Portuguese companies to internationalization projects, with investment in R & D and technological competence in Portugal," adds Apifarma, who recalls that "the Portuguese pharmaceutical industry has faced several legislative challenges and economic challenges that have led to increased challenges and a strategic reorientation for international markets. "

 

Capturing foreign interest:

The innovation has been the bet of BIAL, a Portuguese company that last year registered a turnover of 272 million euros. Regarding the launch of its Parkinson's disease drug in Portugal - it was already on sale in Germany, the United Kingdom and Spain - the pharmacist recalled that international markets have a weight of 70% in billing, when in 2010 it was 30% . The epilepsy drug they launched in 2009 is marketed in 44 countries.

In June of this year, OM Pharma, of the Vifor Pharma Group, inaugurated its new plant in Portugal, an investment of 10 million euros. Located in Alfragide, the facility will produce a drug to treat elevated levels of blood potassium that will be exported to countries around the world, including the United States. By 2000 the company had already relocated part of the production to Lisbon.

Within three years, Generis will have a factory in Rio Maior. An investment of 15 million euros, with the direct creation of 100 jobs. But also indirectly with the creation of a laboratory analysis course by the Professional School of Rio Maior. It is a unit for the reception and packaging of bulk drugs produced in Venda Nova (Amadora) and in India. The annual production of 100 million packages is planned, which means an increase in exports. Angola, Mozambique and Cape Verde, Iran, Lebanon and Libya are among the buyers.

 

 

Challenges of the future:

The three associations are unanimous in saying that Portugal has the potential to continue to grow in this area. The president of Apogen emphasizes the fact that we are seen as a "country with political stability, the prestige that the Portuguese industry has already achieved, with a high level of qualification in this area, a positive relation of the quality-cost of human resources".

"It is essential to promote the importance of the social and economic value of health and its impact across society, given its capacity to generate employment, exports and investment in innovation," says Apifarma, who says there is work to be done. with a view to internationalization. "We must reinforce concrete measures such as the reduction of context costs, support to promote competitiveness and encourage the penetration of companies that produce in Portugal in new markets, while investing in the creation of credit lines to consolidate markets or overcome short-term challenges . "

Joaquim Cunha says that Portugal "should aim to double exports", but recognizes the challenges: "We have a national fabric capable of growing, but if we want to make the leap we have to be able to attract foreign investment. Fiscal stability and lowering red tape are very important. "

 

Source: "Público" Journal website and author on September 17, 2018

País precisa de 500 nutricionistas mas só tem 400 no SNS

País precisa de 500 nutricionistas mas só tem 400 no SNS - 

 

Portugal devia ter, no mínimo, 500 nutricionistas para atingir o rácio de um por cada 20 mil habitantes, sendo que existem apenas 400 no Serviço Nacional de Saúde, denunciou hoje a bastonária da Ordem dos Nutricionistas.

"Em termos globais, no Serviço Nacional de Saúde (SNS), há, em números redondos, 400 nutricionistas, sendo que 100 estão nos cuidados de saúde primários e 300 nos cuidados hospitalares", explicou à agência Lusa a bastonária da Ordem dos Nutricionistas, Alexandra Bento.

Esta responsável visitou hoje a Unidade Local de Saúde (ULS) de Castelo Branco, numa iniciativa inserida no "Ciclo de Visitas da Bastonária" que está a fazer pelas instituições do SNS da região Centro.

Segundo a bastonária, a "boa novidade" prende-se com a abertura de um concurso para 40 nutricionistas para os cuidados de saúde primários: "Podemos dizer que estes 40 representam 40% de acréscimo para os cuidados de saúde primários, o que é uma nota positiva".

"Porém, o número mínimo de nutricionistas que deveríamos ter neste momento deveria ser 500 para atingirmos o rácio de um nutricionista para cada 20 mil habitantes. E temos que continuar este caminho de aumentar o número de nutricionistas nos cuidados de saúde primários, que são locais de excelência para o trabalho dos nutricionistas", sublinhou.

Alexandra Bento explicou que os nutricionistas, enquanto profissionais de saúde, trabalham as questões da alimentação e da nutrição, questões estas que estão muito relacionadas com as grandes causas de mortalidade na atualidade.

"A alimentação é o determinante de saúde que tem mais impacto naquilo que são as grandes causas de mortalidade na atualidade e, portanto, precisamos de mais nutricionistas nos cuidados primários", defendeu.

Adiantou ainda que, em termos de cuidados hospitalares, o que se verifica efetivamente é que há um défice de nutricionistas, sendo que a situação se torna ainda mais preocupante na região Centro.

"O rácio que a Ordem propõe para os hospitais é de um [nutricionista] para cada 50 a 75 camas. Nesta região [Centro], o rácio está muito, muito desfavorecido. Temos hospitais na zona Centro em que temos um nutricionista para 200 camas", frisou.

Contudo, a bastonária mostra-se otimista e realçou mesmo que, atualmente e pela primeira vez, verifica-se uma preocupação por parte da tutela em dar dimensão à área do nutricionismo.

"Nunca, como na atualidade, se verificou uma grande preocupação em trabalhar a nutrição como uma grande área para haver ganhos em saúde. Mas é preciso ainda uma dinâmica muito maior, porque já começámos muito tarde", sustentou.

Alexandra Bento sublinhou ainda que apesar do "muito" que tem vindo a ser desencadeado na atualidade, a urgência da situação exige mais força e mais ímpeto nas medidas políticas na área da nutrição.

Fonte: Site da Revista "Sábado" e autor em 13 de Setembro de 2018

Johnson & Johnson invests millions in new headquarters at Lagoas Park in Oeiras

Johnson & Johnson invests millions in new headquarters at Lagoas Park in Oeiras -

 

The company will inaugurate facilities this Monday and create a clinical trials unit.

Johnson & Johnson inaugurates a new headquarters in Portugal, in Lagoas Park, a business park in the municipality of Oeiras, in an investment of 5.5 million euros, starting with a new clinical trials unit.

"Johnson & Johnson, as a group, is the world's largest healthcare company, and we are clearly committed to strengthening our presence in Portugal [...]. 

We want to continue to grow and we also need to have that space, "Janssen Portugal, the Johnson & Johnson group's pharmaceutical company, told Lusa.

According to Filipa Mota e Costa, the company decided to move Queluz de Baixo's headquarters to a new building in Lagoas Park because previous facilities were "older" and had "no room to grow, but there are more reasons.". 

 

Source: "Correio da manhã" JNewspaper website and author on September 10, 2018.

 

INFARMED approved funding for 15 new medicines

INFARMED approved funding for 15 new medicines -

Most of the innovative medicines, funded or reimbursed, are for hospital use, including molecules for the treatment of oncological diseases (three drugs), multiple sclerosis (two drugs) and cardiovascular diseases, with six new drugs approved.

 

Patients with access to new oncology drugs:

The National Drug Authority approved the reimbursement of three more treatments against cancer.
Oncology patients treated at National Health Service hospitals will have access to new drugs. Infarmed has approved the reimbursement of three more innovative drugs.

The treatments are intended for gastric neoplasms, lymphoblastic leukemia and lung cancer and had a green light during the first half of this year to be used in the state units.
In addition to the treatments against malignant neoplasias, it was also approved the state's contribution to another 12 new drugs. The majority, seven, is indicated for cardiovascular diseases, two for the central nervous system, as is the case of multiple sclerosis, and the others for osteoporosis, pulmonary hypertension, blood and genitourinary disorders.
Last year, Infarmed approved a total of 60 new molecules and 51 in 2016, both numbers record.

 

Source: "Expresso" Journal website and author on September 7, 2018.

 

Bayer is down on net profits in the first half

Bayer is down on net profits in the first half -

 

German chemical and pharmaceutical group Bayer reported a 16.8% drop in net profit in the first half of the year, amounting to EUR 2,753 million due to the acquisition of Monsanto and the divestment of plastic producer Covestro.

Bayer reported today that operating profit (EBIT) fell by 5.9% (3,661 ME) in the same period, with a growth of 1.2% in turnover (18,619 ME).

"We are on the right track to reach the annual targets," Bayer president Werner Baumann said in the semiannual balance sheet presentation.

On June 7, Bayer closed US $ 63 billion (54,310 ME) of the US producer of transgenic Monsanto, including its debt.

"The acquisition of Monsanto brought together two strong businesses that complement each other: the innovative portfolio of plant chemicals and biologicals and Monsanto's extraordinary knowledge of seeds and plant properties," said Bauman.

"We are now a leading company in the agricultural sector," added the Bayer president.

Exchange rates in the second quarter of 2018 had a negative effect of EUR 130 million on Bayer's results.

The purchase of Monsanto also generated extraordinary expenses of 363 ME in the second quarter and 441 ME in the first half.

Net income decreased 34.7% (799 ME) in the second quarter because Covestro no longer contributed to the result.

The level of indebtedness, at the end of June, reached 44,697 ME due to the purchase of Monsanto.

The pharmacy department reduced operating profit by 4.5% (2,216 ME) between January and June, on non-prescription drugs, food supplements.

Body care products fell by 22.2% (368ME); agricultural products also declined (3.8%) while veterinary substances increased by 5.2% (245 ME).

Bayer expects a turnover of 39,000 ME in 2018, with Monsanto accounting for five million euros.

The sale of some businesses to BASF, which was a condition that regulatory authorities have established for the approval of Monsanto's acquisition business, will reduce Bayer's revenues by 1,000 ME.

 

Source: "Diário de Notícias" newspaper and author on September 5, 2018.