‘Regulatory Reliance’ Projects Bearing Fruit In Caribbean & Africa
Initiatives to promote information sharing and reliance among developing country regulators are bearing fruit in the Caribbean and Africa, although much works remains to be done, according to speakers at last week’s pre-ICDRA conference in Dublin.
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Thomas Senderovitz, head of the Danish Medicines Agency and chair of the EU’s Heads of Medicines Agencies, talks to the Pink Sheet about his agency’s agreement with the WHO on strengthening regulatory agencies in lower income countries, and why it is the “obvious thing to do.”
The WHO is planning to introduce a new version of its tool for evaluating the “maturity level” of national drug regulatory agencies across the world as part of a drive to strengthen regulatory systems and make them more effective and transparent. It is also introducing the concept of "WHO-listed authority".
A pilot project of joint assessments in East Africa has shown that regulatory review times for a number of branded medicines were reduced from one or two years to a median of seven months, representing a reduction of 40-60%. The project was part of the African Medicines Regulatory Harmonization initiative, which is intended to strengthen and align regulatory practices in sub-Saharan Africa. Part one of this article looks at the history of the AMRH, the 2016 Model Law that guides national regulators in implementing their own procedures, and the East African pilot that has shown joint reviews to be feasible at the regional level.