EMA Unveils Simple Innovation it Hopes can Help Boost Regulatory Efficiency

Posted 11 February 2014 | By Alexander Gaffney, RAC 

Can a string of numbers or letters improve the European regulatory process?

EU regulators are hoping the answer is "yes," and have a plan to put that theory to the test.

In an 11 February 2014 announcement, the European Medicines Agency (EMA) said it is unveiling a new Unique Product Identifier (UPI) system that will apply a unique code to each new medicine the agency receives for review.

The tracking code will reportedly help the agency keep track of applications, improve the efficiency of its review processes, and "help create a unique platform for all pre-authorisation activities."

UPIs will be applied to all new medicines-not existing ones or ones already under review-at the agency, including any seeking orphan designation, scientific advice or pediatric development procedures.

Companies filing an application with EMA will need to submit a registration form to EMA with basic information on the medicine and send it to an EMA email account to receive a UPI.

The form calls for information on:

  • product trade name or company code
  • active substance(s) (INN, code, chemical designation or description)
  • proposed indication
  • company name
  • customer account number
  • information about prior applications for the same medicine
  • which pre-authorization procedure is being applied for

Thereafter, all interactions with the agency with respect to that medicine will need to reference that UPI.

 

EMA Statement


Tags: EU

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