news human medicines

August 2, 2010 - Authorisation of medicinal products in the first half of 2010

In the first six months of 2010 the Medicines Evaluation Board (MEB) approved approximately 870 medicinal products and entered them into the register. This is an increase of approximately 1% with respect to 2009, which shows that the authorisation of medicines has remained more or less constant. The MEB has refused marketing authorisation for 1 medicinal product and suspended 5 medicinal products. On 30 June 2010, there were 13,382 authorised medicinal products resulting in a slight increase with respect to 30 June 2009.

Active role in Europe for new medicinal products

A medicinal product can receive a national marketing authorisation through a national procedure, a decentralised procedure or a mutual recognition procedure. A medicinal product can obtain a European marketing authorisation from the European Commission through a centralised procedure. The MEB has a role in all procedures as the national medicinal products authority.

In the first half of 2010, the MEB acted as (co-)assessor in 9 new applications that developed from the centralised procedure. With that the MEB retains a leading position in Europe for this procedure.

In the first half of 2010 the MEB started 10 mutual recognition procedures (MRPs) and 46 decentralised procedures (DCPs) in its role as RMS (source MEB). The total number of MRP and DCP procedures started in Europe increased in 2010 (source CMD). The MEB’s share among the European Member States for both procedures jointly is about 12%, illustrating that the MEB plays a very active role in both MRP and DCP in Europe.

Pharmacovigilance

In the first six months of this year 13 reports of risk information about medicinal products (Direct Healthcare Professional Communications, DHPCs) were sent to doctors, pharmacists or other medical professionals. The MEB coordinates these letters.

This Biannual Report is based on currently available data.

The MEB evaluates and monitors the efficacy, risks and quality of human and veterinary medicinal products. The MEB also assesses the safety of novel foods for human consumption.

Go back Overview »