The Generic Drug Cluster is a multi-country forum established by FDA to help improve alignment between regulatory agencies and achieve a common understanding of regulatory requirements for generic drugs. As well as aligning requirements and approaches to developing and assessing generic drugs, the Cluster aims to promote the development and availability of generic medicines worldwide.

In its one-year progress report, published at the end of July 2022, the Administration outlined progress made during the Cluster’s inaugural year. The Administration highlights the importance of collaboration between regulators in an increasingly globalized pharmaceutical market, where actions taken in one country can affect other countries. 

The Administration has called for harmonization between agencies through increased transparency, which they say could help to streamline interactions between industry and regulatory agencies, ultimately speeding up patient access to generic drugs.

Unlike the International Council for Harmonisation (ICH), the Generic Drug Cluster is focused on establishing early communication between regulatory agencies in order to establish alignment proactively. 

Accordingly, the Cluster organizes opportunities for collaboration and information sharing. In preparation for these meetings, FDA Office of Generic Drugs establishes procedures for topic proposals and confidentiality. 

Meetings so far have focused on topics including high priority generic drug applications, rationale for approval of complex drug products, application data sharing, and comparing different regulatory approaches.

Key achievements from the first year of the Generic Drug Cluster include:

• An agreement for gathering and assessing data from participating agencies for an oncology drug
• An agreement for data gathering and combining for a mental health treatment – both potentially leading to a faster approval pathway
• Sharing of data on human testing on certain drugs – potentially increasing the pool of testing populations and accelerating time to approval for some drugs
• Starting to establish a process for sharing data integrity concerns, within a structured and secure information-sharing environment.

Looking ahead, the Cluster aims to reach scientific consensus of approval standards for generic drugs, including complex drug products, which they hope will form the basis of future ICH guidelines.

The ultimate goal of the Cluster is to facilitate the more efficient development and approval of generic drugs and to ensure similar standards worldwide. They say this will give patients access to high-quality generic drugs in a cost-effective manner.

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