Regulatory Terms Starting With P

Patient Narrative (Patient Narrative)

A structured clinical narrative describing the adverse event experience of an individual trial subject, required in clinical study reports.

Patient-Reported Outcome (PRO)

An outcome measure that comes directly from the patient about their health condition without interpretation by a clinician or anyone else.

Pediatric Exclusivity (Pediatric Exclusivity)

A six-month extension of existing market exclusivity and patent terms granted by FDA in return for completing pediatric studies requested by the agency.

Pediatric Investigation Plan (PIP)

The EU regulatory requirement for sponsors to submit a plan for pediatric development of a medicinal product to EMA's Paediatric Committee.

Pediatric Study Plan (PSP)

The FDA-required plan for pediatric development of a drug or biologic, submitted as part of NDA and BLA applications.

Periodic Benefit-Risk Evaluation Report (PBRER)

A periodic safety report format harmonized by ICH for presenting comprehensive benefit-risk analysis of medicinal products.

Periodic Safety Update Report (PSUR)

A periodic report summarizing the global safety profile of a marketed medicinal product.

Pharmaceuticals and Medical Devices Agency (PMDA)

Japan's regulatory agency responsible for approving pharmaceuticals, medical devices, and regenerative products.

Pharmacodynamics (PD)

The study of a drug's biochemical and physiological effects on the body and the mechanisms underlying those effects.

Pharmacokinetics (PK)

The study of how a drug moves through the body: absorption, distribution, metabolism, and excretion over time.

Pharmacovigilance (PV)

The science and activities relating to the detection, assessment, understanding, and prevention of adverse drug reactions.

Pharmacovigilance System Master File (PSMF)

The document describing the pharmacovigilance system operated by a Marketing Authorization Holder for EU-approved medicinal products.

Phase 1 Clinical Trial (Phase 1)

The first stage of clinical testing in humans, primarily assessing safety, tolerability, and pharmacokinetics.

Phase 2 Clinical Trial (Phase 2)

Clinical trials evaluating a drug's efficacy and optimal dosing in patients with the target disease.

Phase 3 Clinical Trial (Phase 3)

Large-scale pivotal trials that confirm a drug's efficacy and safety to support regulatory approval.

Post-Marketing Commitment (PMC)

A study or clinical trial that a sponsor has agreed to conduct as a commitment to FDA but is not required by statute or regulation.

Pre-Approval Inspection (PAI)

An FDA facility inspection conducted before approval of an NDA, BLA, ANDA, or equivalent to verify cGMP readiness and submission accuracy.

Pre-Submission Meeting (Pre-Sub)

A meeting with FDA to discuss regulatory questions before submitting a marketing application.

Premarket Approval (PMA)

The FDA process for approving Class III high-risk medical devices based on clinical evidence of safety and effectiveness.

Prescription Drug User Fee Act (PDUFA)

US legislation that allows the FDA to collect fees from drug manufacturers to fund the new drug approval process.

Primary Endpoint (Primary Endpoint)

The main outcome measure of a clinical trial, selected before the trial begins and used as the primary basis for the trial's conclusion about efficacy.

Priority Review (Priority)

An FDA designation that reduces the review time for drugs treating serious conditions and providing significant improvement over available therapy.

Process Analytical Technology (PAT)

A framework for designing, analyzing, and controlling manufacturing through timely measurements of critical quality and performance attributes.

Process Validation (PV)

Documented evidence establishing high confidence that a process consistently produces a product meeting specifications.

Process Validation (PV)

Documented evidence that a process consistently produces a product meeting predetermined specifications and quality attributes.

Protocol Amendment (Protocol Amendment)

A formal modification to an approved clinical trial protocol requiring documentation, IRB approval, and where applicable regulatory notification or approval.

Purple Book (Purple Book)

FDA's database of biological products licensed under the Public Health Service Act, including originator biologics and biosimilars.