Challenges & Potential Global Convergence of the Regulatory Approval Process for Complex Generic Drugs

The number of complex generics (CGx) entering the market in the U.S. has remained dismally low, despite how many come off-patent each year. Though U.S. Food and Drug Administration (FDA) periodically releases Product Specific Guidances to support development of new CGx, stagnation can be still attributed largely to a lack of enough clear regulatory guidance. On the other hand, in most countries globally, regulatory agencies do not explicitly define non-biological complex products (NBCPs), either innovators or CGx, as a distinct entity, and have not developed specific guidelines or guidances to address the challenges posed by their complexity; thus contributing to the global paucity of these products. Pharmacopeial standards are key to ensure the quality, safety, and efficacy of CGx entering the global market, and will help support and accelerate registration. However, their development also present multifaceted challenges due to the complex nature and great diversity of NBCP.
An exploration of global convergence in CGx regulatory approval processes can address forthcoming needs to provide access to effective and quality-assured medicines to people in countries that lack regulatory guidance for CGx.