EMA and WHO have published a co-authored article on the evaluation of the WHO Collaborative Registration Procedure using Stringent Regulatory Authorities’ medicines evaluations (SRA CRP), its achievements and impact in improving timely access to quality-assured medicines worldwide, where EMA acts as a Stringent Regulatory Authority.
The regulatory approval of medical products in countries with limited regulatory resources can be lengthy, which often compromises patients’ timely access to much-needed medicines. The SRA CRP is a procedure that allows National Regulatory Authorities (NRAs) to leverage the work performed by Stringent Regulatory Authorities (SRAs) on scientific evaluations to decide on medical products approvals within their jurisdiction, through the use of the concept of reliance. Reliance enables regulatory authorities to use assessments performed by other regulatory authorities while maintaining national sovereignty, by making the best use of limited resources, avoiding duplication of work where possible and reducing the time for access. The SRA CRP involves the collaboration between NRAs, SRAs and the pharmaceutical Industry. Since its establishment in 2015 until July 2021, 88 product applications have been submitted through the SRA CRP and 59 approvals were granted to 16 medicines in 23 countries. The evaluation results show that SRA CRP enables faster access to quality-assured, safe and effective medicines for patients in need. The procedure reduces the time from submission to approval, avoids duplication of efforts, and decreases workload and human and financial resources in resource-limited countries, leading to greater efficiency in the regulatory processes. The full article with open access can be found on the following link: https://www.tandfonline.com/doi/abs/10.1080/17512433.2022.2037419?journalCode=ierj20