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# FDA, EMA Collaborate on Post-Approval Changes
- URL: https://www.fdaweb.com/fda-ema-collaborate-on-post-approval-changes/
- Published: 2023-07-28T12:00:00.000Z
- Updated: 2026-09-14T18:47:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154979

FDA and the European Medicines Agency (EMA) have completed the first collaborative assessment of a proposed post-approval change for a critical cancer biologic with Japanese regulators serving as an observer. The collaboration resulted in approval for the undisclosed manufacturer to add new manufacturing and quality control sites for increasing supplies of the drug, the agency says in a [new post](https://www.fda.gov/drugs/news-events-human-drugs/cder-collaborates-global-regulators-pharmaceutical-quality-assessments-and-inspections?ref=fdaweb.com) on its Web site.

“This collaboration is the first achievement in an international pilot program conducted as part of the International Coalition of Medicines Regulatory Authorities’ (ICMRA) Pharmaceutical Quality Knowledge Management System (PQKMS) effort to bring regulators together to enable better industry quality management to reliably supply critical medicines for patients in need,” the agency says. The multi-year pilot aims to lead to “greater regulatory reliance (meaning regulators in one country are able to consider the assessments of regulators in another country) when making decisions about a product and enable greater manufacturing quality management and agility for industry,” it says, adding that this is the first step in harmonizing chemistry, manufacturing, and controls (CMC) assessments and inspection-related regulatory procedures worldwide.

“Further regulatory collaboration in ICMRA, coupled with CDER’s ongoing standards efforts in other international regulatory harmonization and information-sharing bodies, such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), can drive toward a single assessment outcome across regions,” FDA’s post says.

Additionally, the collaboration is working on a hybrid inspection pilot that will conduct a collaborative facility assessment using a combination of on-site inspection and remote assessment tools. “A regulator from one country will perform an on-site inspection with regulators from one or more other countries remotely connecting at the same time,” the agency says. “The pilot aims to identify the best virtual platforms and information technology (i.e., video) to facilitate concurrent on-site inspection and distant assessment. The pilot will also develop protocols and reports for performing hybrid inspections to share with other ICMRA regions.” FDA further says the pilot will help regulators “rely on the pre-approval inspections of other regulators, reduce or eliminate the need for multiple on-site inspections from various regulatory authorities and help to avoid duplicative assessments relating to CMC-related post-approval changes.