LONDON – The EMA and the heads of all the national regulatory bodies across Europe, have for the first time set out a common strategy to deal with global threats including antimicrobial resistance, epidemics and counterfeit drugs.

Europe's regulatory system – now serving a population of more than 500 million – has always relied on cooperation between the EMA at the center and the national regulators. However, to date, the EMA and the Heads of Medicines Agencies (representing 31 national regulators) have drawn up and worked on separate strategies.

Now they say the need to strengthen collaboration has become more urgent. The EU Medicines Agencies Strategy to 2020 provides a blueprint for sharing resources and expertise to work together in priority areas.

The plan does not cover all the work that will be carried out across Europe's regulatory network over the next five years, but those areas where concerted effort is required. It encompasses both human and veterinary medicines, which is significant because about 75 percent of new diseases that have affected humans over the past decade were caused by pathogens originating from animals or products of animal origin.

The first priority is that regulators keep abreast of advances in science, to ensure optimal development of novel products. This requirement and other strands of the strategy were presaged last month by Tomas Salmonson, chair of the EMA's Committee for Human Medicinal Products, speaking at the EMA's 20th anniversary celebration in London.

Salmonson told delegates that scientific advances such as the rise of personalized medicine will change how regulators do business. "There's a clear message for me: Regulators should stimulate innovation in better ways, identifying where innovation is coming from and using accelerated review and conditional approval," he said.

While cost and complexity continue to rise, patients are making greater demands in terms of access, and the strategy says the perception is that the regulators need to do more here. There will be a focus on the adaptive pathways pilot project, with the development of tools for proactive pharmacovigilance, real-time monitoring and rapid learning, to underpin this approach.

Such flexible licensing pathways make it critical to monitor products throughout their life cycle and to view development, licensing, reimbursement and use in clinical practice as a continuum, the strategy says.

Health technology assessments (HTA) and the need to negotiate with separate national bodies over pricing and reimbursement are seen as creating post-approval hurdles and further slowing down access. While these areas are outside the remit of the EMA and the Heads of Medicines Agencies, the strategy makes a commitment to promote convergence in HTAs and encourage interchange between HTA agencies and pricing and reimbursement bodies.

There will be a review to assess if there should be new regulatory incentives to support development of novel products, or products for particular indications, with a suggestion that treatments for dementia should be singled out. As Salmonson said at last month's meeting, "We have to look at what is not being developed. We have done well in Orphan Drugs and oncology, but in other areas there is no development."

Antimicrobial resistance is another focus of the strategy, with a promise both to facilitate market access for new antibiotics, but also to promote their responsible use. In that respect, a "One World" approach will be taken, bringing together expertise from human and veterinary medicine. There will be research to better understand the relationship between the use of antibiotics in animals and the development of antimicrobial resistance and transmission pathways, to enable targeting of control measures.

Based on the model of Europe's response to the Ebola epidemic, which saw rapid provision of scientific advice, a prompt review of the status of experimental medicines coming through the pipeline, swift authorization of phase I trials and a high level of cooperation between regulators and companies, the strategy commits to guaranteeing a rapid response to future emergencies.

The globalization of the pharmaceutical industry, with its lengthening and convoluted supply chains, makes oversight increasingly difficult and means Europe is increasingly confronted with drug shortages. These can be caused by counterfeiting, theft, disruption of manufacturing and non-compliance with GMP requirements.

The strategy promises greater cross-border collaboration to smooth out supply problems and a concerted effort to control the illegal supply of pharmaceuticals through websites in third-world countries.

There is also a commitment to address the increase in clinical trial activity outside the U.S. and EU, and the associated ethical concerns, and to stem the rise of counterfeiting.

About 80 percent of active pharmaceutical ingredients used in medicines approved in Europe are now produced elsewhere, and a substantial number of products are partially or fully manufactured outside the EU. There will be increased attention to controlling and monitoring all links in the supply chain, both at an individual company level and through regulatory inspections and audits.

Ways of enabling information sharing to enhance oversight, such as linking inspections databases, will be explored. While it presents a challenge, the globalization of pharmaceutical operations will be turned to advantage and used as a wedge to drive convergence of standards in good manufacturing and good clinical practice, increasing confidence in inspections by regulators that apply equivalent standards.

As globalization marches on, regulators in developing countries are increasingly looking to the EU's network structure as a model for regional harmonization. The strategy implies this will be encouraged and there will be support for capacity building.

The strategy is now open for public consultation, with comments invited up to June 30.