Outcome of the EMA's survey on centralised post-authorisation procedures

12 October 2016

Outcome of the EMA's survey on centralised post-authorisation procedures

October 12, 2016

In 2013-14 the Agency initiated a major exercise whereby all the established processes for the evaluation of human medicinal products were reviewed and re-designed with the aim to simplify the existing ways of working and provide better support to its Scientific Committees and the Network.

In that context it was important, in line with EMA stakeholders’ management principles, that the Agency gathers feedback from its directly impacted stakeholders further to these changes. An EMA-Industry Survey on centralised post-authorisation procedures was therefore launched in April 2015 to collect feedback from both industry stakeholders and EMA on the level of satisfaction with certain high volume post-authorisation procedures that have been extensively re-designed, namely Type IB variations, Type II variations and PSUR procedures.

The survey results showed a high level of overall satisfaction from both respondents (EMA staff and MAHs) across the three procedures in terms of procedural management, level of interaction and overall communication for the updated procedures. It also identified some areas for further improvement such as proposals for additional simplification and aspects of EMA guidance that necessitated further development.

A number of follow up actions towards improvement of the quality of submission, further increase on consistency and transparency on validation and procedural simplifications have been triggered. All guidance updates and certain of the proposed simplifications in the lifecycle management of the RMP and the quality of the product have been delivered within 6 months from the post-authorisation survey.

Read the full report: Outcome of the European Medicines Agency survey on centralised post-authorisation procedures 2015

Source: EMA