The European Union has offered a new proposal that would further harmonize the pharmaceutical regulations between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), which could speed new drug approvals and manufacturing inspections in both regions.
The seven-page proposal, released ahead of Transatlantic Trade and Investment Partnership (TTIP) negotiations between the EU and the US, would create a specific annex in those trade talks on medicinal products.
Under the EU proposal, FDA and EMA would further harmonize their respective requirements and procedures for approving new drugs, further remove unnecessary and duplicative preclinical and clinical testing and eliminate duplicative inspections of manufacturing facilities.
In addition, the proposal looks to further EMA and FDA dialogue on scientific matters, which may cover research, development and assessment of different types of drugs, generics, biosimilars and medicinal products of major public health interest, or that address unmet medical needs, including those eligible for accelerated regulatory review.
Further collaborations will take place around the development of guidelines, recommendations and initiatives to promote the development of rapid diagnostics, alternative treatments and new antimicrobials as part of efforts to combat anti-microbial resistance.
To read the article by Zachary Brennan