Pfizer Director: Need for regulatory commitments clarity in NDAs, and US FDA concurs

On the third day of the AAPS annual conference in San Diego, Senior Director of Global CMC (Chemistry, Manufacturing and Control) at Pfizer John Groskoph spoke of how the Common Technical Document (CTD), an internationally agreed set of specifications used as part of the application dossier for the registration of medicinal products, could benefit the quality of drugs along with the jobs of drugmakers and regulators.

“The current CTD structure blends and mixes manufacturing data and commitments, and therefore there is no single place where the regulatory commitments are fully listed​,” he told the room.

This would bring a number of advantages, he continued: “The CMC reviewer knows exactly what they are approving and the marketing authorisation holder knows exactly what they are agreeing to. It is crystal clear for both sides.”​

Such clarity is particularly useful for site inspections with regulators able to compare the application form directly with the batch record while the facility itself can be fully prepared as to what to expect due to the lay out of the documentation. This structure helps ensure both drugmaker and regulator are on the same page and, furthermore is “excellent for post-approval regulatory changes,” ​Groskoph said.

Turning Japanese​

Pfizer is part of the US industry group PhRMA which is reviewing the approval process to structure the Quality overall Summary (QOS) in the CTM like that of Japan’s Pharmaceuticals Medical Devices Agency (PMDA) and Health Canada where full commitments are set out clearly and concisely.

“In Japan these are directly built in so you can preplan as to what any future post-approval manufacturing changes will have,”​ Groskoph said.

Now is the perfect time for these documents to be changed, said Robert Iser – Associate Director for Policy Development at the Center for Drug Evaluation and Research (CDER) – who, speaking as part of the same symposium, said the restructure at the US FDA announced last month​ “is the perfect opportunity to discuss integrating quality reviews and regulatory commitments.”​

He added the need for change in the application process is due to the “paradigm shift to a quality of culture” ​and a science and risk-based approach would be employed going forward for establishing regulatory commitments.