EGA Press Release

Monday, 23 October 2007

EUROPEAN GENERIC MEDICINES INDUSTRY AND REGULATORY AUTHORITIES
LAUNCH JOINT WORKSHOP ON BIOEQUIVALENCE

The CMD(h) has agreed to participate with the European generic medicines industry to improve the interpretation of guidelines and standards within the bioequivalence arena.

To achieve this objective the 1st EGA Workshop on Bioequivalence will take place in Lisbon, Portugal on Wednesday, 24 October 2007, organised by the European Generic medicines Association (EGA) under the title “Study Design, Working to GCP and Interpreting the Guidelines: The Keys to a Successful Generics Application”. The workshop will involve representatives from generic pharmaceutical companies and EU regulatory agencies.

Key topics for discussion include:

• Working to GCP, GCP inspections and their consequences,
• Guidance for the development of generic inhaled products,
• Highly Variable Drugs, Widening of Confidence Intervals,
• Future developments to Regulatory Guidance.

Each of these topics represents issues that either the generic medicines industry or the CMD(h) see as needing some clarification to allow the timely introduction of affordable generic medicines. This will be achieved by addressing key points that could lead to reducing the number of referrals of applications due to bioequivalence and to improving the quality of bioequivalence studies. Ultimately the EGA is aiming to help reduce the pressure on the authorities’ current limited resources for assessments thereby reducing the time required to process marketing authorisation applications.

More than 80 representatives of generic pharmaceutical companies and over 60 representatives from agencies and academia will attend this workshop.

The workshop represents one in a series of initiatives being taken by the EGA in conjunction with EU authorities to help improve the efficiency and working of the EU approval system and to maintain high standards of quality for generic medicines.

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