EMA announced that it has upgraded its EudraGMP database to include information on GDP in addition to GMP. The new EudraGMDP database is a key deliverable of the Falsified Medicines Directive (FMD) that came into effect in January 2013. The aim is to increase supply chain security in the EU by making supervision of manufacturing and distribution of medicines more robust to ensure supplier compliance. Those involved in the supply chain will be able to check information available on their suppliers.
EudraGMDP is a modification of the EudraGMP database, which was first launched in April 2007 to facilitate the exchange of information on compliance and noncompliance with GMP among the regulatory authorities within the European medicines network. The database currently contains manufacturing and import authorisations; GMP certificates; statement of noncompliance with GMP; and GMP inspection plans in countries outside the EU.
Over the next few months, medicines regulatory authorities in EU member states will upload distribution-related information as it becomes available. The additional information will include wholesale distribution authorisations; GDP certificates; statements of noncompliance with GDP; and registrations of manufacturers, importers (including information on their suppliers) and distributors of active substances.
The new system follows the new GMP inspection planning module introduced in December 2012 for countries outside the EU. It was developed to make better use of inspection resources by sharing of information among EU regulators and avoiding redundant inspections.
Most information in EudraGMDP is accessible by the public except for information of commercially or personally confidential nature. The decision on which information can be made public is made by the medicines regulatory authority in the member state that uploads the information to the database.
About the FMD: The directive was adopted to protect patients and consumers from falsified medicines by strengthening supervision of the supply chain of medicinal products and active substances entering the EU. New requirements of the FMD can be divided into four categories: safety features on medicines; supply chain and GDP; active substances and excipients; and Internet sales.