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25 June 2018

EU and US seek to streamline generic approval process

The European Commission, European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have said they will work on streamlining the scientific requirements for  approving generic drugs.

This was one of the key takeaways from the organisations’ bilateral meeting on June 18 and 19 in Brussels, Belgium. The meeting allowed the strategic partners to review their ongoing cooperative initiatives and discuss upcoming strategic priorities.

In a press release, the agencies said they took the opportunity to better understand “the fundamentals of legal, regulatory and scientific requirements for approving generic and hybrid applications”.

The organisations will work to identify possible ways of streamlining “the scientific requirements for such approvals with a particular focus on complex generics and hybrids”.

Next steps include further collaboration between the regulators on the product-specific guidelines that they develop.

The agencies also discussed the mutual recognition agreement on pharmaceutical inspections on good manufacturing practices. The agreement currently covers 14 EU member states, with plans for it to be implemented across all member states by July 2019.

The organisations agreed to work closely at the technical level to further streamline the process and measure progress made.

Another topic of discussion was developing advanced therapy medicinal products (ATMPs). The agencies agreed to encourage “early parallel scientific advice” for ATMPs and develop common scientific approaches on regulating them in order to best facilitate preclinical and clinical development.

The Commission, EMA and FDA also said that they will exchange information and work together on methodologies to optimise real-world evidence to support regulatory decision making throughout a product’s lifecycle.

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