Eignapharma is a company operating in the pharmaceutical business engaged in providing services to the industry peers, especially qualified and experienced in Business Development, Pharmacovigilance, Regulatory Affairs, GxP Compliance.

Use of mobile technologies to scan labelling and PL of medicinal products

The EMA has published a document containing the principles and rules of procedure to use mobile technologies to scan the labelling and package leaflet (PL), so patients and healthcare professionals have a different option to obtain statutory or additional information related to medicinal products.  However, mobile technologies cannot replace statutory information like the printed PL.

You can find all the information here.

Launch of the new EudraVigilance System: Q&A from stakeholders

The EMA has updated their Q&A document on the new EV System; new questions have been added (collected from the Service Desk and from EMA webinars held), and several responses have been updated. The EMA recommends consulting this document before contacting the Service Desk. You can check the document here.

Premis Creatic 2018

Eignapharma is proud to have sponsored the 18th edition of Premis Creatic, an award recognising entrepreneurial projects related to technology and innovation. Eignapharma was invited to be a member of the jury and we must say that all applicants did an excellent work and submitted very interesting projects. The awards ceremony took place on November 28th and brought together entrepreneurs, start-ups and self-starter of the territory. It was a great evening and we are very fond of the winning innovative ideas.

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: https://bit.ly/2OAdMXu

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. https://europa.eu/!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 https://bit.ly/2ysLFTQfor 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.



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