A group of four pharmaceutical industry associations in Europe is proposing a set of guidelines meant to help European National Competent Authorities (NCAs) and the European Medicines Agency (EMA) alleviate drug shortages through better communication.

In its report, the group recommends a set of harmonized standards for how drug shortages caused by quality or manufacturing issues are communicated to relevant authorities.

Background

Currently, marketing authorization holders (MAHs) in the EU are required under Regulation (EC) No. 726/2004 to pre-notify NCAs if one of their products “ceases to be placed on the market, either temporarily or permanently … no less than 2 months before the interruption.”

Additionally, Directive 2003/94/EC states:

“The manufacturer shall inform the competent authority of any defect that could result in a recall or abnormal restriction on supply and, in so far as is possible, indicate the countries of destination.”

In November 2012, EMA released its Reflection paper on medicinal product supply shortages caused by manufacturing/Good Manufacturing Practice (GMP) Compliance problems, which proposed a number of short- and mid-term actions to address incidences of drug shortages.

In the paper, EMA defines a number of factors that can influence a drug shortage and argues there is a need for collaboration within the European Regulatory Network. The paper also suggests that MAHs should voluntarily report potential shortages related to manufacturing/GMP issues.

The Industry Proposal

In response to the reflection paper, the Association of the European Self-Medication Industry (AESGP), European Federation of Pharmaceutical Industries and Associations (EFPIA), European Generic Medicines Association (EGA) and Plasma Protein Therapeutics Association (PPTA) released a set of communication principles addressing manufacturing/GMP related drug shortages.

The proposal argues that the communication of drug shortages can be better managed with harmonized standards for reporting supply disruptions. The main tenets of the proposal are:

• “An identical trigger point for notification based on:
• an agreed definition of a meaningful disruption
• a triage process that evaluates the risk associated with a potential supply disruption.”
• “A harmonised reporting content and format.”
• “An agreed time point and recipient of the information for all nationally and centrally approved products.”

The group believes the differences in requirements across the various member states and NCAs “creates an unnecessarily complex notification process.” The group says harmonized standards for data and document format requirements would improve reporting by MAHs and make communication between regulators easier.

The proposal also maintains that any information provided to NCAs by MAHs should be kept confidential until both sides agree that public communication is necessary. The group says this provision will help prevent hoarding of products if information relating to a potential shortage is released prematurely.

Industry Communication Principles around Quality and Manufacturing Driven Supply Disruptions