Confirming a manufacturer’s state of compliance in advance of its product entering the US, and establishing a risk-based tiered system with correspondingly different documentation requirements for each tier, are among the suggestions the pharma industry is making to FDA regarding the implementation of the importation provisions in Title VII of the FDA Safety and Innovation Act (FDASIA).
The recommendations were made in response to a request from FDA in mid-June to help it choose an implementation pathway for FDASIA section 713 on admission standards and 714 on registration of foreign importers and good importer practices (GIPs) that would make sense to industry and not be too burdensome.
The agency explained that the import provisions are outside its core expertise and that it is seeking help from industry and other agencies such as Customs and Border Protection (CBP) that know more about handling imports. The comment period closed on August 12.
The request for comments was supplemented by a public meeting in July on FDASIA Title VII implementation, which included a session focused specifically on sections 713 and 714. The background and history of the provisions, along with the questions on which the agency is seeking input, were presented and discussed, and several stakeholders gave their suggestions and concerns.
[CLICK HERE for the complete story. Â Nonsubscribers can purchase the story for $195 by contacting Jonathan Trethowan (Jonathan@ipq.org). Â For subscription/license information, click here.]
See related IPQ stories:
FDA Seeking Industry Input on Quality Metrics to Help Rationalize Its Review and Inspection System
FDASIA Title VII Implementation Priorities and Action Plans Taking Shape
FDASIA Implementation and a Sharpened Focus on Quality Head Center for Drugs’ Agenda
FDASIA’s Catch-All Title XI Includes Provisions on Medical Gases and Nanomaterials
