What is PAS in Regulatory Affairs?

In Regulatory Affairs, PAS stands for prior approval supplement.

Definition of PAS

The term “prior approval supplement” means a request to the FDA to approve a change in the drug substance, drug product, production process, quality controls, equipment, or facilities covered by an approved abbreviated new drug application when that change has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product.

We have detailed lecture session on PAS under section 5 – ANDA filing section of Executive Program in International Drug Regulatory Affairs (EPGIDRA) and in Drug Biologic Medical Device Regulatory Affairs (PGDBMRA) course. Moreover the concept and submission planning for PAS is discussed in 1 week certification course in ANDA submission management.

When a pharmaceutical company wants to make significant changes to an already approved drug product or biologic, they need to seek FDA approval for these changes. These changes could include modifications to the manufacturing process, changes in the drug’s labeling or dosage form, or alterations to the drug’s formulation. A PAS is submitted to the FDA to obtain the agency’s approval for these changes before they can be implemented.

The PAS process is used to ensure that any changes to a drug product do not compromise its safety, efficacy, or quality. The FDA reviews the PAS to determine whether the proposed changes are acceptable, and if so, they may issue an approval for the modification. This process is crucial to maintaining the quality and safety of pharmaceutical products on the market.