Drug Approvals in EU and US: Harmonization of Rules at FDA and EMA
[Posted on: Thursday, June 02, 2016]

FDA and EMA have been increasingly harmonizing regulatory requirements in Europe and US for most drug and biological products for the last two decades and it seems soon they may get even closer. This week European Medicines Agency (EMA) released a report disclosing ongoing discussions with FDA to set up ground rules for simultaneous review and approval of drugs, biologics and other regulated products for human and veterinary use. The goal of these discussions is to find common grounds for defining safety and efficacy so manufacturers can reduce duplication of studies conducted in support of market approval. This would assure that drugs and biologics are approved almost at the same time in the two regions. It has been conventional wisdom that studies conducted in the US are acceptable in EMA and, in many cases; studies conducted in EU are accepted by the FDA. Non-clinical studies and manufacturing requirements were harmonized many years ago with the implementation of ICH guidance documents for those areas of research; and so were the application formats with the Common Technical Document (CTD). Some applications can even be filed jointly such as the joint FDA/EMA application for orphan drug designation. Joint meetings with FDA and EMA are also feasible. However, regulatory agencies still differ in their interpretation of acceptable risks and benefits, disease burden, vulnerable populations, privacy concerns, and the social and economic costs. Also Agencies duplicate a lot of their own efforts such as GMP inspections. FDA does not accept a GMP certificate issued by another regulatory agency, rather conducts its own audits. The proposed agreement aims to take a holistic approach to address the differences and expand the similarities. Under the agreement, FDA and EMA will jointly develop scientific and technical guidelines for developing and approval of products, will communicate and share information with each other (including confidential and trade secret information) regarding review and approval of products, accept each other’s GMP certificates or equivalent documents, and share GCP and other inspection reports. The shared information will used solely to make decisions about the same product across agencies and the confidential and trade secret information will not publicly disclosed. EMA and FDA will create a joint Working Group to assure the implementation of the agreement. The agreement is expected to be finalized by 2020. These discussions between EMA and FDA have been conducted under broader cooperation initiatives called the Transatlantic Trade and Investment Partnership (TTIP). TTIP is a hot political issue on both sides of the Atlantic; it is hard to know if and when it will be implemented. But harmonization between FDA and EMA is not a new initiative. The two agencies have been working closely for many years. The demographic makeup of populations in EU and US are getting increasingly similar. There is strong support in the regulatory communities to work closely and avoid unnecessary studies. There is also strong public support for make new treatments available faster across the two regions. It is important that the manufacturers take advantage of this environment and seek joint approvals of their products in the EU and US.