On 3 April 2018, the EMA has published a 4-page public consultation document concerning the European Union template for GMP non-compliant statement. The GMP/GDP Inspectors Working Group is currently discussing possible actions required if inspections conclude with serious GMP non-compliance when at the same time this conclusion would block the availability of life-saving medicines. “What happens when?” is the question that EMA is now putting up for public discussion.
So far, in such cases, a statement of non-compliance is the outcome of the risk-assessment of GMP-compliance of an inspected site. Following the principles of ICH Q9, the concerned member states subsequently have to decide how to manage the risk (recall, prohibition of supply, suspension of MIA etc.). Where those actions might lead to shortages of critical medicines in a particular member state of the European Union, the competent authority of that member state might decide to mitigate and accept the risk. However, this risk acceptance does not change the initial risk-assessment; the site will remain non-compliant until satisfactory corrective actions are taken.
With this consultation, the EMA aims at collecting relevant information from stakeholders to help the GMP/GDP Inspectors Working Group to develop an effective and harmonised risk-based approach for dealing with the supply of critical medicines in case of serious GMP non-compliance. As a result, the outcome shall then amend the compilation of community procedures and exchange of information (CoCP) by:
- Separating processes of risk assessment and risk control
- Accelerating public release of non-compliance statement
- Avoiding generation of conditioned GMP certificates along with non-compliance statements
- Providing specific guidance for Qualified Persons to facilitate release batches of critical drug products.
The document, including the updated “Statement of non-compliance with GMP” is open for public consultation until 15 May 2018. Please refer to the original paper for more details on this.