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Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.
This is the first time a single strategy document for both EMA and HMA is presented, reflecting the need for a coordinated approach to address the challenges and opportunities facing the European regulatory system network.
The European Medicines Agency (EMA) and the heads of medicines agencies (HMA) have published a consultation draft outlining their network strategy for the next five years. This is the first time EMA and HMA have presented a single strategy document that reflects the need for a coordinated approach to address the challenges and opportunities facing the European regulatory system network.
The document highlights areas in which the network seeks to make an impact on over the next few years leading up to 2020. Four themes were presented as part of the network strategy-human health, animal health, optimization of network operation, and the need for more collaboration in the regulatory environment in response to the increasing globalization of the pharmaceutical industry.
With advances in science, it is important for the regulatory framework to evolve accordingly so that new medicines can be developed optimally for the health benefit of European citizens. Antimicrobial resistance was identified as a major threat to public health, creating an urgent need for new antibiotics to treat infectious disease. And with an aging European population, diseases such as dementia have added to the public health burden.
Innovative advanced therapies are emerging, with personalized medicines representing an increasing part of the armamentarium. However, the costs and complexities of drug development continue to present hurdles. While the European regulatory framework offers some degree of flexibility in drug approval pathways, more work needs to be done to enable patient access to promising new drug at the earliest opportunity. The situation calls for the concept of adaptive licensing to be explored and a lifespan approach with drug development, licensing, reimbursement, clinical application, and drug monitoring as to be viewed a continuum.
The following objectives were outlined in the chapter pertaining to human health:
The European Commission, in proposing a new legal framework for veterinary medicines, identified four principle objectives-to increase the availability of veterinary medicines, to reduce the administrative burden on regulators and the industry, to improve the functioning of the European veterinary medicines market, and to minimize the risks from antimicrobial use in the veterinary domain.
The same four objectives will drive the network strategy in the run up to the new legislation:
The EU recognizes that collaboration and cooperation between all parties in the network are key to a successful regulatory framework. There are, however, a number of challenges, such as health issues, progress in regulatory science, societal trends, upcoming legislative and political changes, and the impact of further globalization, which must be addressed to ensure efficient operation of the network.
It has been noted that high-quality scientific and regulatory expertise will play a crucial role in facilitating the progress of regulatory science. The network also wants to ensure that scientific and operational procedures carried out by single or various players within the network are efficient and cost-effective, thereby, minimizing as much as possible the administrative burden for pharmaceutical industry commensurate with public and animal health.
Over the next five years, the network will undertake initiatives to achieve the following objectives:
Contributing to the global regulatory environment
Globalization of pharmaceutical activities has resulted in increased reliance of manufacturers from developing countries, which has brought with it the challenge of protecting the supply chain from counterfeit operations. Moreover, data from clinical trials conducted outside the EU will need to be properly monitored.
One of the priorities of the network is to contribute to the global regulatory environment and enhance greater collaboration with parties outside the EU. The emergence of new international coalitions where there is a coordinated and consistent approach, which avoids duplication, will have implications on the European network.
The following objectives were outlined in this chapter of the network strategy document: