Novartis AG (ADR) (NYSE:NVS) is spearheading efforts geared towards accelerating the approval of new drugs in one of the world’s poorest regions. The company in partnership with other drug makers are ramping up support for the East African Community Medicines Registration Harmonization program, which they hope will make the region friendlier to new medicines.
East African Community Medicines Registration Harmonization Program
The agency which represents six countries, is modeled like the European Medicines Agency with the sole mandate of speeding the approval of new medicines. Patients in East Africa are usually among the last ones to gain access to new drugs, devices, and diagnostics, once they are made available to the rest of the world.
That is however set to change thanks to the new body that is poised to trim the lengthy processes needed for regulatory approval of new medicines.
Reducing Assessment Steps
The body will streamline regulatory procedures needed for the approval of new drugs across Kenya, Tanzania Uganda, Rwanda, Burundi and South Sudan. The agency is to operate as an independent institution, providing oversight for essential medicines. Its evolution into an official agency is poised to take not less than two years.
“Key to bringing EAC to full strength and scale will be ensuring medicines are reviewed within a predictable time scale with member countries completing the final registration step without unnecessary replication,” said Rob Kowalski, Novartis global head of regulatory affairs
Roche is another drug maker ramping up support for the agency as it is expected to reduce redundant assessment steps needed for new drugs to hit the market. According to the company’s spokeswoman, Anja von Treskow, the agency could lead to single dossier submission process in the six countries.
A push for a harmonized drug approval process in the East African region by giant drug makers does not come as a surprise. The companies are currently looking for new markets for new drugs in a bid to reduce the amount of time it takes to recoup investments on new drugs.
Novartis was down by 1.05% in Wednesday’s trading session to end the day at $82.74 a share.
