16/17 May 2023
The HMA (Heads of Medicines Agencies) and the EMA (European Medicines Agency) have issued a high level EU document in order to plan the strategy of the EU regulators for the upcoming 5 years. On 27 March 2015 a consultation draft entitled "EU Medicines Agencies Network Strategy to 2020" has been published. This document comprises a lot of information about potential improvement in marketing authorisation procedures and controls but also contains some interesting GMP information.
HMA and EMA recognize the need for a tight control of suppliers located outside the EU. Today 80% of the APIs used for the manufacture of medicinal products in Europe are manufactured at production sites outside the EU (a majority in Asia, e.g. India and China). In addition the two regulatory bodies are concerned about out of compliance situations as found in several sites in Asia. Especially failures to establish a system and to maintain the data integrity of GMP information is critical for patient safety. The report says: "The complexity of international supply chains present risks of errors and occasionally counterfeits or product diversion. Key to ensuring supply chain integrity is to make sure that all steps in the supply chain are adequately controlled and monitored, both at an individual company level and through appropriate regulatory oversight including inspections and audits.....Closely linked to these challenges is the need to ensure the integrity of the data on which regulatory decisions about medicines are based."
According to the report the HMA and EMA "will ensure that all suspicions of problems with data integrity are thoroughly investigated working closely with other international partners where these data may have been generated or used."
In parallel initiatives have been introduced by Member State authorities as well. For example the MHRA just recently published their expectation on GMP Data Integrity. It is likely that other agencies in Europe will follow this approach. Also US FDA intends to define their expectation on Data Integrity in a Guideline (please read more about the new FDA inspection focus on data integrity)