The end of 2000 saw the creation of a new testing scheme focusing on post-marketing surveillance of Mutual Recognition Procedure (MRP) products, which includes generic medicines. This scheme was initiated on a voluntary basis by members of the General European OMCL Network from EU/EEA Member States and the EDQM, the Network's secretariat. The participants are known as the testing group. After a 4-year trial period, it was decided, in May 2005, to continue with an annual work programme. Since, this scheme has regularly been followed by approximately 20 OMCLs from 12-15 member states. It is based on the principles of work-sharing and sharing of test results. Both are possible because the MRP enables marketing authorisation (MA) of a medicinal product in more than one EU/EEA Member State. To guarantee communication among participating OMCLs, the EDQM has installed an IT share point. By avoiding duplicate testing of the same product in different member states, the scheme provides a coordinated and cost savings approach to post-marketing surveillance. Currently, about 500 medicinal products are tested for quality per year within this programme.
A new challenge for the testing group was the implementation of a new community marketing authorisation procedure, the decentralised procedure (DCP), in force since October 2005. This was the end of the transition period for the ratification of the relevant European Parliament and Council Directives (i.e. Directive 2001/83/EC relating to medicinal products for human use as amended by 2004/27/EC and Directive 2001/82/EC relating to veterinary medicinal products as amended by Directive 2004/28/EC). The decentralised procedure provides equivalent grounds for testing in all member states, as the MA of a DCP product (similar to an MRP product) is based on the same dossier. During the annual meeting of the General European OMCL Network in May 2007, it was decided to include post-marketing surveillance of DCP products within the group's scope.
For a complete description of this scheme's procedure, download the document "Co-operation in post-marketing surveillance of Mutual Recognition/Decentralised Procedure Products (PA/PH/OMCL 06 116 7R)" via the right-hand menu.
The 8th annual programme of the MRP/DCP Post-Marketing Surveillance Scheme was carried out in 2012. More than 800 product testing projects were allocated to the 2012 programme, which is an increase compared to former years. The number of participants has stabilised in recent years to around 25 OMCLs per annum.
The most tested products during 2012 were generic medicines, including the following active pharmaceutical ingredients (APIs): combinations with hydrochlorothiazide (diuretic drug), clopidogrel (anti-platelet agent, inhibition of blood clots), metformin and glimepiride (anti-diabetic drugs), valsartan and amlodipine (anti-hypertensive) and donepezil (acetylcholinesterase inhibitor, treatment of mild to moderate Alzheimer’s disease).
Approximately 10 per cent of the samples tested in 2012 originated from a member state or OMCL that was not involved in the testing. This matches the global picture of the test programme over recent years and demonstrates the added value of the surveillance scheme with respect to work-sharing. In about 3 per cent of the tested materials, findings of a regulatory nature (e.g. insufficient details of the test method, wrong calculation formulae used in the SOP) could be identified and, in 2 per cent of the cases, one or more out-of-specification (OOS) results were reported. This demonstrates the good quality of medicines on the European market. About 5 per cent of the tested products were for veterinary use and approximately 3 per cent were biologicals, which reflects the general distribution of product types registered via these European procedures. In 2012, for the first time more DCP than MRP products were included in the programme.
The internal database used for planning, sampling and reporting of MRP/DCP product testing activities within the Network was further developed. A total of 11 database amendments were implemented in 2012. These were initiated both by OMCL users of the system and the EDQM Secretariat. Currently, the database is being enlarged to allow, in the future, the reporting of API testing activities independently from the marketing authorisation type of the corresponding drug product.
To date about 4,800 projects have been registered, 34 OMCLs have so far contributed as Testing OMCLs, 43 OMCL records have been established and more than 180 OMCL representatives are registered users of the database. The database plays an important role in the discussions within the Heads of Medicines Agencies group on how to improve collaboration between regulators/assessors, inspectors and OMCLs.
In December 2012, the co-ordination activities of the EDQM with respect to the MRP/DCP product market surveillance scheme, which are certified for ISO 9001, successfully underwent a re-audit.