A pilot study conducted by Janssen Pharmaceutica Inc., which is part of Johnson and Johnson has shown that Collaborative Regulatory Procedure (CRP) work. The study was conducted in 11 African countries implementing the African Medicines Regulatory Harmonization (AMRH) Initiative with a focus on three Stringent Regulatory Authorities (SRA) approved medicines; (1) a pediatric formulation of Janssen’s antiretroviral drug Intelence (ectravirine) 25mg of oral tablets (2) another Janssen’s antiretroviral, Prezista (darunavir) (3) and a Tuberculosis drug Sirturo (bedaquiline) which is currently undergoing the pilot with the first submission made in February 2016.

Janssen Pharmaceutica Inc. has described the results from the pilot as very encouraging and they are looking at options to improve this process. According to an earlier survey conducted by Bill and Melinda Gates Foundation (BMGF) the median for drug approval was 20 months, but the results from the pilot study by Janssen Pharmaceutica Inc. indicate that a median of 7 months was recorded from a total of 9 countries out of the 11 sampled.

The target review time for the pilot study was pegged at 90 days. In the first pilot, Namibia was able to meet this target by registering antiretroviral drug Intelence (ectravirine) in 86 days, just 4 days below the target. This shows that it is possible to reduce drug approval times. In the second pilot involving Prezista (darunavir), submission of the product began in November 2015 and the first drug approval was granted under the CRP in August 2016.

The SRA used in this study was European Medicines Agency (EMA). The national authorities’ under study were encouraged to use EMA assessment reports and inspection reports. There is need to continue working with African Union (AU) Member States and Regional Economic Communities (RECs) through the AMRH Initiative to encourage them to rely on SRAs and not duplicate assessments if one has already been done and promote joint assessments.