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The European Agency for the Evaluation of Medicinal Products

Evaluation of Medicines for Human Use

London, 14 December 2000

CPMP/EWP/QWP/1401/98

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS

(CPMP)

NOTE FOR GUIDANCE ON

THE INVESTIGATION OF BIOAVAILABILITY AND

BIOEQUIVALENCE

DISCUSSION IN THE JOINT EFFICACY AND QUALITY

WORKING GROUP

December 1997October 1998

TRANSMISSION TO THE CPMP

July 1998

RELEASE FOR CONSULTATION

December 1998

DEADLINE FOR COMMENTS

June 1999

DISCUSSION IN THE DRAFTING GROUP

February – May 2000

TRANSMISSION TO THE CPMP

July - December 2000

RELEASE FOR CONSULTATION

December 2000

DEADLINE FOR COMMENTS

March 2001

Note:

This revised Note for Guidance will replace the previous guideline adopted in December

1991.

Any comments should be sent to the EMEA, EWP Secretariat (Fax No. 44-20-74188613)

before the end of March 2001.

7 Westferry Circus, Canary Wharf, London, E14 4HB, UK

Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13

E-mail: [email protected] http://www.eudra.org/emea.html

EMEA 2000 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged

INVESTIGATION OF BIOAVAILABILITY AND BIOEQUIVALENCE

TABLE OF CONTENTS

1

2

INTRODUCTION

2

DEFINITIONS

3

2.1 Pharmaceutical equivalence

3

2.2 Pharmaceutical alternatives

3

2.3 Bioavailability

3

2.4 Bioequivalence

3

2.5 Essentially similar products