Regulatory

Prior to 1995 all drugs have received national approval in each European country.  Each country had its own procedures for authorizing a marketing application for a new drug. Therefore, the approved drug information, especially indications and dosing regimens may vary widely across European countries.

Today there are three procedures for submitting a Marketing Authorization Application (MAA) in the EU: (1) the mutual recognition procedure (MRP); (2) the decentralized (DCP) and (3) the centralized procedure (CP). The submission strategy for a given product depends on the nature of the product, the target indications, the history of the product, and the marketing plan.

Some of the purely national marketing authorisations (MA) are still in force within the EU were granted in accordance with old, disparate, national standards, dating from a time when medicines agencies did not exist. The product information authorised through a purely national procedure are often insufficiently informative, or even misleading and their content varies between countries. Processes for organising a systematic re-assessment of all old national MAs are essential to secure the effective and safe usage of approved drugs.

In today’s European environment and increasing trend to global harmonisation, the variability in approved product information is not acceptable any more.  Therefore, EMA has strengthened its efforts to harmonise the product information across European countries.

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