Collaborative procedure in the assessment and accelerated national registration of pharmaceutical products and vaccines approved by stringent regulatory authorities - Annex 11
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TABLE OF CONTENTS
3. Principles of collaborative procedure
5. Collaboration mechanisms for management of post-registration variations
Appendix 7 Expression of interest to national regulatory authority
Appendix 8 Confidential disclosure agreement
1. Background information
Management of diseases known to be of major relevance to public health in countries with limited regulatory resources is often jeopardized by delayed access to new or needed therapies. Although many medicines successfully pass a regulatory review process conducted by internationally respected regulatory bodies, also known as stringent regulatory authorities (reference SRAs), or may in addition have been prequalified by the World Health Organization (WHO), local regulatory approvals tend to consume additional time and resources of national regulatory authorities (NRAs) before these therapies can be made available to patients.
Collaborative procedure in the assessment and accelerated-annex 11