World Antibiotic Awareness Week (12-18 November 2018)

Antibiotics have been widely used since their discovery. However, due to overuse and misuse in human and animal health, resistant bacteria have emerged, which has become a public health threat.

World Antibiotic Awareness Week intends to transmit this information to the public worldwide and seeks to spread awareness of the proper use and prescription of antibiotics with different campaigns.

You can contribute by sharing your message via social media for the European Antibiotic Awareness Day.

Check it up at:

Workshop on Electronic Product Information (ePI)

On 28-Nov-2018, the European Commission, the Heads of Medicines Agencies and EMA will do a workshop about the electronic formats of the EU product information (SmPC and PL). The aim of this workshop is to create a draft proposal as to how electronic formats can be used to provide the product information. This workshop will be broadcast live and a video recording will be available after the event.!FX69VU 

SPOR implementation

SPOR completed one year of live service and remains the highest priority for the EMA. In this period, integrations with electronic Application Form or EudraVigilance registration system took place, and the consolidation with Art.57 and Clinical Trials was also initiated. SPOR implementation is expected to continue steadily despite EMA relocation. #SPOR #EMA

For more information, check the minutes of the task force meeting.

Fluoroquinolone and quinolone antibiotics

PRAC recommends restrictions on use of fluoroquinolone and quinolone antibiotics following a review of disabling and potentially long-lasting side effects. Once the CHMP has adopted the final opinion, the new restrictions will become applicable in all EU Member States. Keep an eye on further information. #pharmacovigilance #PRAC #antibiotics

Monitoring of signals evaluated by the FDA

The list of safety signals being evaluated by the FDA has been published in its second Quarterly Report. We recommend monitoring worldwide signals as they might have an impact in your products in EU and ROW. We’ll be happy to include your products in our regular screening, we have an experienced team waiting for you.

Eignapharma: New EuDRAcon member

Eudracon, the leading network on regulatory affairs experts in Europe, has elected Eignapharma as its member representing Spain. Eignapharma is honoured with such appointment and is certain that this will only result in benefit of its customers and partners.

Biosimilars: Biogem & Eignapharma

Eignapharma announces that it has reached a collaboration agreement with Biogem (Molecular Biology and Genetics Institute). Biogem is specialised in lab scale development and production of biosimilars, monoclonal antibodies, new biological entities and related preclinical studies, either own promoted or contract projects assigned by industry stakeholders. Under this agreement Eignapharma will use its commercial efforts to put at the industry disposal Biogem’s research and development capabilities consisting on documented small-scale processes and fully protocolised technology transfers procedures to allow a safe scaleup to industrial production.

La AEMPS ha publicado la Orden Ministerial que inicia el procedimiento para el registro de los productos homeopáticos

Los titulares de productos homeopáticos dispondrán de un plazo de tres meses para comunicar a la AEMPS su intención de registrar sus productos como medicamento en base a la Orden Ministerial SSI/425/2018 de 27 de abril. Esta medida se lleva a cabo para adaptarse a la Directiva 2001/83/CE del Parlamento Europeo y del Consejo, de 6 de noviembre de 2001. Puedes consultar la Orden Ministerial aquí.

European Immunization Week (EIW) 23–29 April 2018

From 23 to 29 April 2018, the European Region celebrates European Immunization Week (EIW) to raise awareness of the importance of immunization for people’s health and well-being. For this purpose, the EMA has produced a video together with the community of patients, consumers, doctors, nurses and pharmacists across the EU, who took the time to explain why vaccination matters. #VaccinesWork #ImmunizeEurope #patientsafety

FEDRA receives an award from @asLAN association

FEDRA (the Spanish Agency database containing all notifications of adverse reactions produced by medicines) has been awarded by the association @asLAN in the category “Improvement in communication with the citizen”. Congratulations!



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