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Regulatory Focus™ > News Articles > WHO Pilot Project Speeds Approval of Janssen HIV Drug in 11 African Countries

WHO Pilot Project Speeds Approval of Janssen HIV Drug in 11 African Countries

Posted 19 February 2016 | By Zachary Brennan 

WHO Pilot Project Speeds Approval of Janssen HIV Drug in 11 African Countries

A World Health Organization (WHO) pilot project looking to bring already-approved drugs to Africa more quickly will continue into 2016 after four of 11 participating African national medicines regulatory authorities (NMRAs) approved Janssen’s pediatric HIV drug Intellence (etravirine).

As of November, regulators from Namibia (approved 86 days after submission), Cote d’Ivoire (four months), Botswana (six months) and Kenya (seven months) have approved the use of the drug, which was previously approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2008.

The pilot has effectively reduced the approval process from what’s normally a two-year wait and brought it down to between three and eight months.

After Janssen and the EMA agreed to share detailed outcomes of full assessment and inspection reports with the initial group of African NMRAs, the NMRAs were asked to provide approval and WHO facilitated the data transfer process.

Preparations to apply the procedure to other selected medicines are under way, WHO’s Monika Zweygarth told Focus. Piloting of the procedure will continue into 2016 until sufficient experience in application of the procedure’s mechanisms has been gathered to enable final guidance to be drafted, WHO said.

Janssen said in a report presented in Denmark that it felt that the African reviewers were very thorough and gave adequate time to respond, though the approval reports “did not reflect all realities of the African environment.”

Face-to-face meetings between the African regulators also led to comparison of practices between the different countries (e.g., number of samples) which may facilitate regulatory harmonization, Janssen said. But as far as the price for the HIV drug, Zweygarth told Focus that the "WHO procedure focuses on evaluation of quality, safety and efficacy of the products, it does not deal with pricing."

Pilot Details

WHO says the pilot is meant to focus on generic and innovative medicines of significant public health need (e.g. antiretroviral, TB or malaria medicines, maternal health medicines or contraceptives) that have been approved by participating stringent regulatory authorities (SRAs).

Helping to train between five and 10 national regulatory teams to assess these drugs in line with international standards is one of the primary goals, WHO said, noting that the pilot prioritizes medicines prequalified by WHO, medicines invited for WHO prequalification, or medicines of specific interest to WHO disease programs or with other special relevance (e.g. pediatric formulation).

For other pharmaceutical companies willing to participate, WHO is looking for participants that can:

  • Assure the NMRA that the product to which the procedure will be applied is the "same" as the EMA- or FDA-approved product.
  • Make sure the dossier is organized in the common technical document format (CTD) under which it was approved by EMA or FDA. For innovative medicines, WHO says it may be advantageous to submit in addition to existing overviews a "bridging report" which discusses data relevant for the countries of submission if the assessment report does not cover these elements to sufficient extent.
  • Provide full assessment and inspection reports generated by EMA or FDA or other more stringent international regulators.

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