EMA Launches Consultation on GMP Non-Compliance Statements

Yesterday, the European Medicines Agency (EMA) opened a public consultation period concerning the European Union’s template for Good Manufacturing Practice (GMP) noncompliance statements. The EMA says that its GMP Inspectors Working Group is considering which actions will be required after an inspection concludes that a manufacturing site does not comply with GMP, especially in cases in which a statement of noncompliance could lead to a shortage of critical medicines.

When a facility is deemed noncompliant, the concerned EU member states must decide how to manage the risk, using tactics that may include recall, prohibition of supply, or suspension of a manufacturing and importation authorization. However, in cases in which any those actions could lead to a drug shortage of life-saving drugs, national authorities might decide to “mitigate and accept” the risk posed by the site’s conditions, even though the site will remain noncompliant until corrective actions have been completed.

The EMA proposes to revise its Compilation of Community Procedures on Inspections and Exchange of Information to separate the processes of risk assessment and risk control, accelerate public release of noncompliance statements, avoid giving conditional GMP certificates together with noncompliance statements, and provide specific guidance to facilitate the release of critical drug products.

The newly announced consultation seeks to collect relevant information from stakeholders to help the working group to develop a harmonized, risk-based approach to dealing with the supply of medicines in cases of serious noncompliance, and the EMA will accept comments on its proposed updates until May 15, 2018.

This consultation follows a 2012 reflection paper on supply shortages caused by GMP compliance issues, in which the EMA noted that “The industry’s risk management tends to be very reactive rather than proactive,” and called for collaboration among authorities at a global level to prevent shortages of life-saving medicines.

The outcome of the consultation is not only of interest to EU member states, but also to the United States in this era of growing regulatory coordination; the FDA can currently rely on the GMP Inspections carried out by multiple EU member state agencies. in November 2017, the FDA announced that it recognized the regulatory bodies of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom as capable of conducting manufacturing inspections that meet FDA’s own standards. In March 2018, Czech Republic, Greece, Hungary, and Romania were added to FDA’s list of recognized inspectors, and more nations are expected to join the list by the end of 2018.