Numerous achievements in pharmacovigilance in a 4-year period
In December 2019, the European Medicines Agency (EMA) published a report measuring the longer-term impact of the pharmacovigilance legislation, based on a review of 4-year pharmacovigilance activities (from 2015 to 2018).
The report provides a description and analysis of the impact on public health measures, including their contribution to a strong and adaptable EU pharmacovigilance system.
This period includes the following:
- More than 500 new or updated risk management plans were assessed by the PRAC each year, ensuring the safety monitoring and risk minimisation is proportionate and planned.
- Nearly 7000 risk management plans were assessed by the Member States for nationally authorised medicines during the reporting period.
- Enhanced EudraVigilance database, resulting in improved reporting of suspected side effects and greater analytical power.
- Evaluation of nearly 9000 potential signals by EMA’s signal management team over the period.
- Radical simplification and improvement of the way Periodic Safety Update Reports (PSUR) are handled by establishing a common repository with a single portal for access.
- Development of criteria to determine when a public hearing on issues of medicines’ safety would be of value. Examples of this were evident in 2017 for valproate-containing medicines and in 2018 for quinolone and fluoroquinolone antibiotics.
Important progress has also been made in the areas of transparency, communication and engagement with stakeholders. The reporting period shows increases in patient reporting of suspected adverse drug reactions, as well as significant progress in terms of scientific methods (EU funded projects such as EU PROTECT, WEDRADR and ADVANCE, SCOPE and others).
The period covered by this document includes important progress on delivery of improved IT systems and simplification of processes, including translations of signals into all EU languages, a single assessment process and single point of safety reporting.
In accordance with this report, earlier engagement of pharmacovigilance will optimise surveillance and risk minimisation as soon as products enter the market, thus making the current effective system even stronger and safer.
As a reliable partner, Marti Farm offers a full package of regulatory services in pharmacovigilance, regularly monitors regulations and promptly updates its system according to all necessary changes. Pharmacovigilance regulations are one of the strictest to follow, but through numerous audits Marti Farm has proven itself and shown that it possesses a well-organised and top-class system able to meet such rigorous requirements.
As EMA was developing its system and database, Marti Farm was in parallel working on Sympto®, its multi-client safety database and pharmacovigilance solution. Sympto® was designed in particular for the purpose of minimising risks and facilitating the detection of potential signals, and represents an excellent tool for both basic and advanced pharmacovigilance tasks. Since Sympto® enables a detailed analysis of important safety data with statistical significance, we can say that Marti Farm not only follows trends but is also one step ahead of them.
Ana Bolonja / MSc
Lašćinska cesta 40
Planinska ulica 13/2
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Full company name
Short company name
Marti Farm Ltd. Trade and Services
Marti Farm Ltd.
Lašćinska cesta 40, HR-10000 Zagreb
Planinska ulica 13/2, HR-10000 Zagreb
a limited liability company
Commercial Court of Zagreb
HRK 20,000.00 (paid in its entirety)
Martina Diminić Smetiško, director of the
company (Representing the company
individually and independently, Responsible
person for data protection)
HR3623600001102197724 (Zagrebačka banka)
HR4324020061100628669 (Erste banka)
Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Lašćinska cesta 40, HR-10000 Zagreb
Office: Planinska ulica 13/2, HR-10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)
Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)