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January 16, 2013 - MEB in figures: 2012

This past year, the Medicines Evaluation Board (MEB) has processed and concluded a record number of cases. This amounted to a total of more than 25,000 cases.

The move to Utrecht took place on 29 February 2012. The new office environment and the implementation of “@nders werken” (different work strategies) contributes both to the efficiency of the organisation and the stimulation of creating a bond between employees. The MEB aims to perform the public task in the area of authorisation and monitoring of medicines adequately and to improve even further in this task. We are very proud that no significant backlog occurred during this hectic period.

An overview of the preliminary achievement figures that are currently available is provided below. The definite figures may differ. The definite figures will be finalised and placed into context in the annual report for 2012, which will be published in June 2013.

New applications and authorisations

  • The number of approved and authorised medicinal products based on existing ingredients was over 1,200. (2011: 1,800)
  • This brings the total number of authorised medicinal products for human use in the Netherlands to more than 15,000. (2011: 14,000)

Changes to medicinal products

  • New indications were added to 53 authorised medicinal products. (2011: 53)
  • The extensive information for doctors and pharmacists (SmPC) of approximately 4,000 authorised medicines was amended. This includes both amendments and total revisions. (2011: 4,000)
  • The package leaflets of approximately 5,000 authorised medicinal products were amended. This includes both amendments and total revisions. (2011: 5,000)

Backlogs

  • There was a backlog of 212 cases as of 31 December 2012. In general, these backlogs existed due to waiting for further information from the applicant. As soon as this information is received, the relevant case will be processed with the highest priority. (2011: 188)

Risk information

  • The number of letters with important safety information about medicinal products for prescribers and pharmacists (DHPC) was 38. (2011: 31)
  • The Pharmacovigilance department carried out approximately 2,600 evaluation tasks. (2011: 2,600)
  • In addition, 92 incoming “Non-Urgent Information” requests (NUIs, requests for non-urgent information about the risks of a medicinal product) were processed. (2011: 89)
  • Three (3) NUI requests were sent to other European member states. (2011: 3)
  • In total, 7 “Rapid Alerts” (RAs) (urgent requests for product-related information) were received from the EMA or an EU member state. (2011: 9)

Suspensions and refusals

  • The total number of (temporarily) suspended medicinal products in 2012 was 5. (2011: 0)
  • A total of 14 marketing authorisations for medicinal products were refused. (2011: 5)
  • MEB in Europe
  • The MEB played a leading role in the evaluation of a medicinal product as part of a European procedure on 230 occasions. (2011: 210) 
  • Research and science

The MEB is closely involved in scientific research that serves the evaluation process. The quantitative results in the field of research and science are listed below:

  • 12 students performed work placement with the MEB in 2012 (2 University of Technology, 10 University).
  • The number of MEB-related PhD promotions that were completed increased from 5 in 2011 to 7 in 2012.
The MEB evaluates and monitors the efficacy, risks and quality of medicinal products for human and veterinary use. The MEB also evaluates the safety of novel foods for humans.

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