Report Says U.S. and EU Generics Standards Should Be Synchronized

European officials are pushing for greater synchronicity between the U.S. and EU regulators on generic approval processes as part of broader trade negotiations.

In a policy paper, the European Commission pitched several short-term policy changes in the U.S. and EU that could be interwoven into ongoing negotiations for the Transatlantic Trade and Investment Partnership with minimal disruption.

“The globalization of the production of medicinal products results in the fact that generic products, similar to innovative products, are increasingly subject to applications for authorization in the EU and the U.S.,” the EC report states. “This creates new opportunities for the protection of public health and calls for strengthening collaboration amongst regulatory authorities.”

The first proposal was for U.S. and EU regulatory officials to participate in an information-sharing pilot project among generic pharmaceutical regulators in Australia, Canada, Switzerland and Taiwan. According to the proposal, the goal is to assess applications submitted to each jurisdiction and to “facilitate the exchange of information for the scientific assessment of generic products” via a master list of active substances.

EC officials said that the U.S. and EU also could cut out regulatory red tape by permitting bioequivalence determinations based on in vitro studies, which could be achieved by harmonizing their respective guidelines for granting waivers on in vivo research.

Lastly, the paper proposes that the U.S. and EU review their guidelines for submitting applications for generics with complex APIs to “decrease the duplication of clinical trials and facilitate the global development of this type of products.”

The report states that if the U.S. and EU could collaborate on these policy changes, it could “pave the way to shape the regulatory cooperation in this area.” — Cameron Ayers


$1,097 $847


Subscribe to Generic Line and save $250 off the regular one-year price of $1,097 — plus receive a FREE copy of our webinar CD, A Biosimilar by Any Other Name — a $287 Value!

Key Benefits

LINKS TO KEY DOCUMENTS — Each issue provides you with links that support GEN's articles such as FDA guidances, warning letters, rules, full texts of proposed legislation and more.

FDANEWS DRUG DAILY BULLETIN — This daily email brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.