WHO Pilot Project Speeds Approval of Janssen HIV Drug in African Nations

World Health Organization (WHO) pilot project seeking to bring previously accepted medicines to Africa more rapidly will continue into 2016 after 4 of 11 participating African national medicines regulatory authorities (NMRAs) accepted Janssen’s pediatric HIV drug Intellence (etravirine).

As of November, regulators from

Namibia (accepted 86 days after submission),

Cote d’Ivoire (4 months),

Botswana (6 months) and

Kenya (7 months),   have accepted the use of the drug, which was earlier Okayed by the US FDA and the EMA in 2008.

The pilot has successfully decreased the acceptance process from what’s generally a two-year wait and brought it down to between 3 and 8 months. More than 25 NMRAs have stated they want to contribute to the pilot, which includes those from nations outside of Africa, such as the Philippines, Georgia and Armenia.

After Janssen and the EMA decided to share detailed results of full assessment and inspection reports with the initial group of African NMRAs, the NMRAs were requested to offer approval and WHO triggered the data transfer process.

WHO’s Monika Zweygarth told

Preparations to apply the process to other selected drugs are under way. Piloting of the procedure will carry on into 2016 till adequate experience in the application of the procedure’s mechanisms has been collected to allow final guidance to be drafted.

Janssen stated in a report provided in Denmark that it believed that the African reviewers were very thorough and gave sufficient time to react, though the approval reports did not reflect all realities of the African environment. Face to face meetings among the African regulators also lead to comparison of practices among the various countries (e.g., number of samples) which may facilitate regulatory harmonization.

Pilot Information

WHO says the pilot is intended to concentrate on generic and innovative drugs of major public health need, for example, TB, malaria, maternal health, antiretroviral and contraceptives drugs that have been accepted by participating stringent regulatory authorities (SRAs).

Helping to train between 5 and 10 national regulatory teams to evaluate these drugs in line with global standards is one of the major goals, WHO said, noting that the pilot prioritizes drugs pre-qualified by WHO, medicines welcomed for WHO pre-qualification, or drugs of specific interest to WHO disease programs or with other special relevance (e.g. pediatric formulation).

For other pharmaceutical organizations willing to take part, WHO is looking for participants that can:

• Ensure the NMRA that the product to which the process will be applied is the similar as the EMA- or FDA-approved product.
• Ensure that the dossier is organized in the common technical document format (CTD) under which it was accepted by EMA or FDA. For innovative drugs, WHO says it may be beneficial to submit in addition to existing overviews a “bridging report” which talks about data appropriate for the nations of submission if the evaluation report does not cover these elements to an adequate
• Offer full evaluation and inspection reports generated by EMA or FDA or other more stringent international regulators.