The South African Health Products Regulatory Authority (SAHPRA) has released a comprehensive "Guideline on Co-applicancy". This guidance provides detailed instructions and requirements for entities involved in the co-application of health products.
Co-Applicancy A regulatory submission approach where two or more entities jointly apply for the registration of a health product.
A Co-applicancy is possible where applicants who are legally separate entities undertake to jointly provide the data as required in guidelines for registration of medicine and who, through a co-applicancy contract, indicate the areas of oversight and responsibility undertaken by the applicants in fulfilling overall regulatory requirements.
As a result, this approach is only applicable to new applications for registration of medicines that meet public health needs, and where it may not be feasible for a single applicant to provide oversight of quality, safety, and efficacy, but where a co-applicant can assist.
The Key Highlights that are covered in this guidance are
Principles relating to Co-applicancy
Requirements for submission of a co-applicancy application
Co-applicancy contract
Pre-submission meeting
Technical requirements for quality, safety, and efficacy
Submission upload onto IT Portal
This guidance on co-applicancy provides a structured framework for entities wishing to jointly apply for the registration of health products. For further details and comprehensive understanding, refer to the SAHPRA Guideline on Co-Applicancy and the full document.
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