The Association of the European Self-Medication Industry (AESGP), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Generic medicines Association (EGA), and the Plasma Protein Therapeutics Association (PPTA) have released joint principles on the communication of information on quality- and manufacturing-driven supply disruptions. This document forms part of the industry response to the European Medicines Agency's call for voluntary and proactive action to address issues of security of supply and continued access to medicines in Europe.
In a statement, the associations point out that there can be multiple causes to medicines shortages, including issues relating to quality and manufacturing. In cases where a disruption to the manufacturing process of a medicine arises, marketing authorization holders (MAHs) are obligated to notify competent authorities (CAs) in a timely fashion. The joint document addresses such communications, and complements the output from other organizations, such as the International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA) on the prevention of such supply disruptions.
"This "Principles" document introduces a harmonized approach to the communication of information by MAHs, meeting the complex and divergent data requirements across national CAs and the EMA," said the associations. "This is expected to facilitate coordinated action between CAs; it will further enable CAs to gather standardized data for the identification and analysis of the causes while considering mitigation strategies. This ‘Principles’ document constitutes a first and concrete step in the right direction and was warmly welcomed by the EMA and national CAs."
AESGP, EFPIA, EGA, and PPTA said that they believe that more can be achieved within the EMA initiative, particularly on reporting and notification mechanisms beyond manufacturers, which should form the next key milestone of the EMA initiative for 2015. This necessitates an integrated solution involving all stakeholders in the supply chain, illustrated in the recent report commissioned by the European Commission's Directorate General for Health and Consumers (DG Sanco), the EU body responsible for ensuring drug and food safety.