Globalisation of the pharmaceutical supply chain means weaknesses in overseas regulators can lead to drug safety scares around the world. To strengthen the chain the Institute of Medicine (IOM) is calling on international and intergovernmental organisations to invest in regulatory capabilities.
“Investments in international medical product safety should be a significant and explicitly tracked priority at development banks, regional economic communities, and public health institutions”, the IOM wrote in a report.
To make best use of resources emerging market regulators should, in the next three to five years, work with industry and academia to advance their science, policies, and training, the IOM wrote.
“A robust regulatory system depends on input from industry and academia; government simply cannot shoulder the burden alone. In some counties this will require a cultural shift”, the IOM wrote.
While helping raise standards around the world regulators in established markets must also improve their own oversight of emerging regions. Continuing to increase sharing between regulators and companies is part of the IOM proposal.
“In the next 18 months countries with stringent regulatory agencies should share their inspection reports of facilities in developing countries. This is a simple step that could reduce a great deal of waste”, the IOM wrote.
Regulators are already moving in this direction, by, for example, sharing API (active pharmaceutical ingredient) inspection reports. Companies are also taking steps – this week the Rx-360 went live with its joint audit programme – and the IOM wants these efforts to continue and expand.
“Sharing inspection results is sensitive but crucial to an efficient product safety system. In the next three to five years, medical product industry associations can work with their members to decide what information to share and how to share it”, the IOM wrote.