Will Transatlantic Regulatory Cooperation Meet Expectations?

There has been increasing cooperation between the EMA and the FDA in recent years, and this looks set to continue in the future. However, with both agencies having been criticised for their approval processes and safety monitoring, will greater regulatory harmonisation be beneficial to industry and accepted by consumers?
Oct 31, 2010

Since 2003, there has been a growing level of interaction between the European Medicines Agency (EMA) and the FDA.1–3 With Europe and the US representing the two largest pharmaceutical markets in the world, cooperation between the agencies has several potential benefits. In particular, the increased sharing of information and opinions regarding medicines will result in better and faster information exchange regarding the safety of products being used in the US and vice versa. If unnecessary differences in regulations (with their associated costs) can be avoided, this would also offer huge benefits to industry. For instance, it may be possible to use similar documentation for submissions to both agencies; indeed, the EMA and the FDA already offer a common application for Orphan Drug Status. There are also practical steps that have been taken; for example, previously European phone numbers could not be entered electronically into the editable fields on the US form! More harmonisation among global regulatory requirements would also help encourage more innovative medicines to be brought to market because sponsors feel that meeting regulatory standards in one region will help them develop their products in another.

Regulatory cooperation also benefits the agencies themselves because they can share experiences and learn more about one another's internal workings. This may also help to avoid duplication of work; for example, the FDA's oncology review team already holds monthly teleconferences with their EMA counterparts to discuss a range of ongoing activities, such as meetings with sponsors, regulatory decisions and even staff exchanges.4 These forums involve the exchange of documents such as minutes from internal agency meetings and important regulatory letters.

In 2007, the two agencies also chaired a Transatlantic Administrative Simplification Workshop, which featured participation from the heads of individual EU member state regulatory bodies and the US.5 The objective was to simplify regulations wherever possible, provided that they did not involve any changes to existing legislation and as long as they maintained (or increased) public safety standards. Given the wide range of activities carried out by the agencies, it was necessary to classify the areas to be targeted under four general themes: quality and inspections; pharmacovigilance; scientific collaboration; and guidelines, format harmonisation and electronic submission. Following the 2007 meeting, a formal Coordination Committee has been established, which consists of a representative from the EC, the EMA and the FDA. They hold regular teleconferences and carry out yearly reviews of the confidentiality exchange agreements. A follow-up meeting was held in September 2009 when the agencies formalised formats, scales and time periods for information exchange.

Other cooperative initiatives between the agencies are also underway. In September 2010, the EMA and FDA announced that an existing programme to allow both agencies to exchange confidential information as part of their regulatory and scientific processes was to be extended indefinitely.1,2 The new arrangement encompasses areas such as scientific advice to sponsors, orphan drug designation, paediatric drug development, and GMP and GCP inspection planning and reports. Marketing authorisation procedures are also covered, as well as any changes to marketing authorisations and postmarketing surveillance.

Differing standards?

Although the two agencies have upped their level of cooperation and share many similar roles, it is important to remember that they remain very different organisations. Whereas the FDA is a unified regulatory agency, the EMA is an administrative organisation that relies on the agencies in individual member states to carry out the functions required. Consequently, whereas the FDA has its own staff for certain roles (site inspections, etc.), the EMA will turn to the agencies in individual member states for such support, which means that EMA decision-making can be influenced by the working culture of the personnel being used from the supporting agencies.6 It is also quite possible that the same data package can generate different opinions from the EMA and the FDA; indeed, a frequent complaint of companies is this perceived divergence in scientific opinions, which makes the process of putting together a development programme that will generate data to satisfy both agencies difficult (and costly).

As part of their cooperative agreement, the agencies now offer voluntary parallel scientific advice, whereby FDA and EMA assessors provide their views on scientific issues during the development phase of new products. However, this move has not fully satisfied companies. Following the advice procedure, both the EMA and the FDA retain their individual regulatory decision-making authority regarding drug development issues, which means that the advice of each agency may still differ after the joint discussion.