Draft VICH GL52 (Bioequivalence) Blood level Bioequivalence Study

Comments are now invited on the draft guideline VICH GL52 (Bioequivalence) Blood level Bioequivalence Study.

The APVMA is seeking submissions from stakeholders to input to step 4 (external site) of the VICH process. If the APVMA proposes to adopt the final guidelines further consultation will be undertaken.

Background

VICH (the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products Program – see http://www.vichsec.org/), is aimed at harmonising technical requirements for veterinary product registration and was launched in Paris in April 1996 as a cooperative effort between members of the regulatory authorities and the veterinary chemical industry from the European Union, U S A, and Japan.

VICH draws on the experience of the human pharmaceutical harmonisation initiative, ICH. The regulatory authorities of Australia and New Zealand have observer status on the VICH Steering Committee. The APVMA adopts VICH guidelines where it is possible and appropriate to do so.

Please make written submissions by email, post or fax to:

Email: vetmedicines@apvma.gov.au

Post:

Veterinary Medicines Program
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Fax: +61 2 6210 4721

Consultations close Friday 28 February 2014 at 6pm (AEDT)

Contact: +61 2 6210 4701