48
N.º Edição
INFARMED Executive Board
meets with EMA’s executive director
The president and the vice president of the INFARMED Executive Board, Maria do Céu Machado and Rui Santos Ivo, travelled to London on the 30th and 31st May to participate in a bilateral meeting with the executive director of the European Medicines Agency (EMA), Guido Rasi, and the executive vice-director Noël Wathion.
INFARMED’S long standing collaboration with the London-based regulator, as well as the relocation of EMA’s headquarters after the Brexit and the subsequent bid to secure the agency in Portugal, are some of the issues that were discussed at this meeting.
In parallel, a technical visit took place, with architects and engineers from the Town Hall of Lisbon and ESTAMO in order to assess matters related to EMA’s future location and the demands for a new building.
Laboratório Militar (Military’s Laboratory) will be modernized to produce eight additional medicines
In the next few years, the Military’s Laboratory will be intervened and further equipped to produce eight new pharmaceuticals in therapeutic areas such as oncology, dermatology, auto-immune diseases, children anaesthetics or tuberculosis. Such medicines have lost their commercial appeal to the pharmaceutical industry because of their low market value and weight. These were measures proposed by an interministerial working group.
This is just a preliminary list, as this Laboratory has the scientific and technical conditions to produce more medicines and products in a near future. To start this project, the human resources will be reinforced and the infrastructures must be readapted in order to comply with the good practices for pharmaceutical products. So far, these medicines accounted for about 2 million euros a year.
The working group created to design this project – with experts from the Health and the National Defence Ministries – also decided to create a strategic national stockpile to respond to unpredictable crisis situations such as an earthquake. Vaccines, antidotes, methadone or treatments for infectious diseases are some of the possible products being analysed.
European experts in Portugal
To audit INFARMED (BEMA)
Between 16 to 18th may INFARMED was audited by European experts, an evaluation under the framework of BEMA – Benchmarking of European Medicines Agencies (a Heads of the Medicines Agency initiative).
The European team had experts from the polish, finish and estonian medicines agencies, that highlighted several good practices to be disseminated as soon as the final report is completed and made available in the database. The results will be soon announced.
This evaluation is part of a benchmarking exercise among the 48 european human and veterinary medicines agencies, being this one the fourth assessment of INFARMED since its first edition in 2006.
BEMA’s aim is to contribute to the development of a world class drug regulatory system, based on a network of agencies operating with the best practices. Its philosophy is to evaluate the systems and processes according to a set of indicators, which determines the state of the art both in the management of the organization and in the business processes of these entities, particularly those related to the evaluation of medicines, pharmacovigilance and inspection.
Growth of 66% in portuguese
clinical trials
In just five years, there was a 66% increase in the number of authorized clinical trials, from 87 to 144 in 2016. In the first quarter of 2017, there were 24 authorized CT. Despite the results, released by the International Day of Clinical Trials, Portugal still has a great potential for growth in the capture of these trials.
There are currently 382 clinical trials in Portugal, involving approximately 830 researchers from 88 research centers. According to data collected by Infarmed, these trials predict the inclusion of 13,000 volunteers, although the actual number of participants tends to be lower at the end of these studies.
As for the research areas, oncological diseases stand out with 43% of these CT, diseases of the nervous system (10%) or rheumatology (8%), and about half are performed in Centro Hospitalar de Lisboa Norte, Centro Hospitalar Universitário de Coimbra, Centro Hospitalar de São João, Centro Hospitalar do Porto e IPO do Porto.
INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.
Parque de Saúde de Lisboa - Avenida do Brasil, 53, 1749-004 Lisboa - Portugal
Telef: +351 217 987 100 | Fax: +351 217 987 316 | E-mail: Infarmed@Infarmed.pt