Abstract
The most significant regulatory initiative that the GCC member states have proactively implemented as part of their goal to standardise their regulatory systems is the Common Technical Document (CTD). The CTD format was adopted in all member states in January 2012 as part of the central registration procedure. This initiative reflected the assessment processes carried out by each individual authority and became the official review practice in all member states including Yemen. Pharmacovigilance (PV) and medicines communication has also been an important initiative by the GCC countries, but it has not yet been fully regulated to reach the European or US standards even though they base their PV initiatives on the European PV guidelines.
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsReferences
American Pharmaceutical Group (APG). (2010). Ensuring access to essential medicines in developing countries. [Online] London: APG. Available from: www.apg.uk.com
CMR International Institute for Regulatory Science. (2009). Review and reimbursement: A special case for better cooperation. CMR International Institute for Regulatory Science Workshop, Surrey, 29–30 September. Surrey: CMR International. Available from: http://www.cmr.org/institute
Eichler, H., Pignatti, F., Bruno, F., Leufkens, H., & Breckenridge, A. (2008). Balancing early market access to new drugs with the need for benefit/risk data: A mounting dilemma. Nature Reviews Drug Discovery, 7, 818–826.
Hashan, H. (2005). Evaluation of the review process for marketing pharmaceutical products in the Gulf states and its impact on patients’ access to medicines. Unpublished Doctor of Philosophy, The Welsh School of Pharmacy, Cardiff University.
Matsebula, T., Goudge, J., & Gilson, L. (2005). Regulating the pharmaceutical sector: Coping with low capacity while maintaining regulatory independence. Health Economics Financing Programme (HEFP) Working Paper 01/05. [Online] South Africa: Centre for Health Policy, University of Witwatersrand. Available from: http://www.hefp.lshtm.ac.uk/publications/downloads/working_papers/01_05.pdf
Author information
Authors and Affiliations
Rights and permissions
Copyright information
© 2015 Springer International Publishing Switzerland
About this chapter
Cite this chapter
Al-Essa, R.K., Al-Rubaie, M., Walker, S., Salek, S. (2015). The Current Status of the Common Technical Document. In: Pharmaceutical Regulatory Environment. Adis, Cham. https://doi.org/10.1007/978-3-319-17590-4_5
Download citation
DOI: https://doi.org/10.1007/978-3-319-17590-4_5
Publisher Name: Adis, Cham
Print ISBN: 978-3-319-17589-8
Online ISBN: 978-3-319-17590-4
eBook Packages: MedicineMedicine (R0)