In 2016, countless drug companies came under fire from the public due to the high market price of their drugs. According to industry experts, one way to deal with this issue of rising costs in 2017 is to actively promote and facilitate generic drug development.
Generic drugs, which are replicas of small molecule drugs already approved and on the market, serve as cost-effective alternatives to expensive brand name products. This is because a generic is cheaper to manufacture than the pioneer product and can be used interchangeably.
But, if the focus on generic drug development increases, so too does the workload for the regulatory agencies charged with reviewing and approving these products for market use. In response to this concern, the International Generic Drug Regulators Programme (IGDRP) has outlined new plans to increase collaboration between generic drug review programs around the world through 2020.
The IGDRP, which was launched in 2015 after the success of the three-year International Generic Drug Regulators Pilot, works to alleviate the mounting pressure that confronts the participating regulatory agencies, and health organizations, through collaboration and convergence. Included in the program is the US Food and Drug Administration (FDA), Health Canada, the European Medicines Agency (EMA), China Food and Drug Administration (CFDA), Japan’s ministry of health, Brazil’s ANVISA, and Mexico’s COFEPROS.
The new plan outlined by the IGDRP looks to:
- Further information sharing between member organizations
- Conduct surveys and produce reference materials summarizing the important similarities and differences between the organizations’ regulatory procedures
- Create a cohort of more advanced regulators to work with those regulators that have less scientific expertise in order to help them better understand the application and interpretation of regulatory practices and guidance documents
- Develop tools to allow easier exchange of assessment reports and other important documents, that often contain confidential business information (CBI), between regulators
- Develop a database that can identify commonly submitted ASMFs/DMFs, as well as other application types that are often submitted to regulatory agencies
To evaluate the effectiveness of this program, an IGDRP Logic Model and Results and Data Matrix have been developed and will be used at periodic stages over the next three years.
The hope is that these efforts will allow regulators to more effectively deal with increasing numbers of new generic drug applications, so that these important drugs can make it onto the market quicker, and offer patients cheaper treatment options.