12 / 2019
The European Medicines Regulatory Network, EMRN) is recognised world-wide as a unique platform for sharing work and co-operating in regulatory affairs in the field of medicines. Regulators from the Paul-Ehrlich-Institut (PEI) and the Croatian medicines authority have analysed the challenges involved in the inclusion of national regulatory authorities in such a network. They studied how the European network could serve as blueprint for a better supply with medicines world-wide (Regul Toxicol Pharmacol, online edition: 06 May 2019).
Access to high quality and safe medicines remains a major challenge in many regions of the world. Harmonising regulatory processes is an effective means of speeding up access to important medicines for many patients. With the development of the European Economic Area (EEA), the regulatory system for medicines in Europe has developed into such an effective instrument.
What are the essential challenges on the road to joining such a complex network as a national authority? Researchers of the PEI, Federal Institute for Vaccines and Biomedicines, and the Croatian regulatory authority (Agency for Medicinal Products and Medical Devices of Croatia) have analysed the specific challenges involved in joining such a network as a national authority, using the access of Croatia – the newest EU member – to the EU as an example. The Federal Ministry of Health (BMG) and the BMG Global Health Protection Programme (GHPP) are promoting this work.
In this context, the focus of the analysis performed by the scientists was on the mutual recognition procedure (MRP) and the decentralised procedure (DCP). These types of procedures were developed from independent legal systems, and can therefore be more easily transmitted to other regions of the world than the centralised procedure, which requires a common legal framework. The harmonisation of legal regulations, administrative methods, and agreements right down to details such as labelling the products was a tedious process involving a major workload. It led to the complex regulatory system which today permits harmonised authorisations of medicines in the European Economic Area (EEA) within European marketing authorisation procedures (centralised procedure, MRP, DCP).
Figures highlight the meaning of such a regulatory network with mutual recognition: in the first four years of Croatia's EU membership, 88 percent of the newly granted marketing authorisations of medicines on average were admitted using one of the procedures in the network such as the mutual recognition procedure, the decentralised authorisation procedure, or the centralised authorisation procedure.
Could this regulatory system serve as a blueprint for other countries and regions in the world to speed up access to safe and efficacious medicines? From the point of view of the authors, this question cannot be clearly answered. "To co-operate successfully, trust is needed, and building up this trust requires clear rules and structures. They further the necessary transparency and provide rules for the confidential exchange of information,"
explained Dr Christoph Conrad, head of the VaccTrain module (regulatory training and advice in the area of vaccines and biomedical therapeutics) in the GHPP of the Paul-Ehrlich-Institut.
The success of the complex European model is based on the development of the European single market. For this purpose, it was necessary to harmonise the legal framework conditions. Besides, with the European medicines regulation, structures were created which help co-ordinate the various procedures and the necessary information in the network. In Europe, these structures can almost be taken for granted, but when observed from outside, they are difficult to understand. However, the framework conditions necessary to co-operate successfully can be defined even under less favourable conditions. The experience gained throughout the decades and the knowledge of the pitfalls on the road to a functioning regulatory network are a valuable source of information in establishing such regulatory organisations, which ideally use existing regulatory capacities and keep administrative complexity to a minimum.
The PEI is committed within the "Global Health Protection Programme" of the Federal Ministry of Health. The aim is to strengthen health systems in Africa and to promote the implementation of international health regulations.
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Updated: 24.05.2019
