ICH Q12 EU Compatibility

International Council for Harmonization and the European Union

The International Council for Harmonization (ICH) is working to make global trade in the pharmaceutical industry easier. According to a recent article, the ICH “issued in December of 2017 a draft guidance aimed at more uniformity in rules on the quality of medicines throughout their lifecycles, particularly in the period after marketing authorization,” known as the Q12 guidelines. The guidelines, made available by the US Food and Drug Association (FDA) last May, are still in draft form and are in the process of undergoing public consultation through December 2018.

The goal of the Q12 guidelines is to cover lifecycle management issues not addressed in the ICH’s previous guidelines Q8-Q11. ICH Q12 covers the management of post-approval chemistry, manufacturing and controls (CMC) processes for both new and marketed drugs. Long term, the guidelines are predicted to reduce costs for regulators and manufacturers, as well as reduce variability and mitigate manufacturing, and quality shortages through the continual improvements on products says the FDA.

According to the Regulatory Affairs Professionals Society (RAPS), “Sections of the draft focus on the categorization of post-approval CMC changes, established conditions, post-approval change management protocols, product lifecycle management, pharmaceutical quality system and change management, the relationship between the regulatory assessment and inspection and post-approval changes for marketed products.”

However, the proposed draft appears to be incompatible with some existing European Union frameworks. “The European Commission, the European Union executive, discovered after a review of EU rules that parts of the guideline could not be implemented in the EU without changes in legislation. This is despite large sections of the guidelines already being implemented in the Union. At the Commission’s insistence but with the backing of regulatory representatives on the experts working group (EWG) drawing up the guidelines, additions were made to the guideline’s introduction about the incompatibility of the guideline with the ‘established legal framework’ in certain ICH regions,” the article states.

Ultimately, the ICH, FDA and EWG are all working toward the same overall CMC lifecycle management objectives. With the deadline for comments in the US approaching, the plan of reducing costs, while increasing post-approval change efficiency is drawing nearer.

Don’t miss the session “ICH Q12: Implications of Guidelines on Risk-Based CMC Operations” presented by Justin Aldridge, Senior Manager, Regulatory CMC at Biogen, at Q1’s 4th Annual Regulatory Affairs CMC: Chemistry, Manufacturing, and Controls Conference on October 29-30 in Philadelphia, PA. Reserve your spot today for more on ICH Q12 and other trending CMC topics.

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