Post Marketing Safety (PMS) Surveillance and Oversight

Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product. Post Market Surveillance (PMS) is the act of monitoring the safety of a pharmaceutical drug or medical device after it has been released in the market and is a significant piece of the study of pharmacovigilance. However, such prescriptions are carried out in a controlled manner.

The development of a drug, right from conceptual stages to the finished product, is considered to be a highly complex process that scrutinizes every little aspect of the drug, thereby providing adequate assurance of its safety at the time of approval. However, to further ascertain the safety of new drugs for human consumption, investigative studies tend to continue after approval. These studies are commonly called ‘postmarketing studies’ or ‘phase IV trials’

Postmarketing surveillance (PMS), in simple terms, refers to the process of monitoring the safety of drugs once they reach the market after the successful completion of clinical trials. The primary purpose for the conduct of PMS is to identify previously unrecognized adverse effects as well as positive effects.

Over the years, PMS practices have undergone considerable evolution, with regulatory authorities realizing the importance of applying appropriate measures to stifle the increasing incidences of adverse reactions.

Since drugs and medical devices are approved based on the clinical trials, which include moderately small number of individuals who been chosen for this reason, implying that they typically don’t have other medical conditions which may exist in the all general population– Post Market Surveillance can additionally refine, or verify or deny, the security of a drug or device after it is utilized in the general population by larger numbers of people who have a wide variety of medical conditions. This has ushered in an era of ‘proactive approaches’ rather than ‘reactive approaches’ with a focus on risk prevention and necessary communication measures.

PMS and PV are based on the core principle that patient health and patient safety are critical factors to be considered when manufacturing and marketing pharmaceutical products. Hence, while PV in a broader sense focuses on adverse reaction reporting along with disseminating knowledge among the healthcare community and patients in order to minimize risks, PMS fulfils the post-approval requirements of assessing and monitoring the potential risks associated with the use of pharmaceutical products in a larger patient population.

Applications of 21 CFR part 822:

✔️21 CFR part 822 can be applied for the manufacturers when the FDA has clearly requested to lead Post Market Surveillance of a medical device.

✔️The FDA has the supremacy quality to arrange Post Market Surveillance of any class II or class III medical devices that meets with the accompanying standards:

✔️The fault of the device would probably have genuine adverse medical problems.

✔️The device is planned to be embedded in the human body for about over one year or,

The device is intended to be utilized for supporting or continuing life and to be utilized outside a user facility.

How to Submit the Post Market Surveillance plan

✔️Once requested by the  US FDA, the device manufacturers must present a PMS plan within 30 days of the date from the receipt of the Post Market Surveillance Order.

✔️Where to send and present this plan is determined in §822.8.

✔️In any case, the FDA requires a submission that incorporates 3 copies of the plan.

✔️The FDA sends an approval letter recognizing the unique report number appointed to the submission when they get the original submission.

✔️This number must be referenced in any correspondence identified with the submission.

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Contents of a PMS submission

✔️Organizational/authoritative data:

✔️Facility name and address

✔️Generic and trade names of the guidance

✔️Name and address of the contact person for the submission

✔️Premarket application/Submission number and device identifiers for the device

✔️Table of content distinguishing the page numbers for each segment of the submission;

✔️Description of the device (this might be joined by reference to the proper premarket application/submission);

✔️Product codes and a list of all important model numbers; and

✔️Indications for use and claims for the device;

✔️Post Market Surveillance plan;

✔️Designated person data;

✔️Name, address, and phone number; and

✔️Experience and capabilities.

Post Market Surveillance is fundamentally more observational than the controlled tests increasingly run of the mill of premarket evaluation; in any case, it gives a significant security net and is the main handy strategy to distinguish medical devices issues that happen at too low a recurrence or simply after delayed use, or are probably not going to be seen until a product has a true use.

Post Market Surveillance has an unusual breadth since the FDA and other able competent will get reports from all products in their nations and, in this undeniably harmonized world, reports from different nations.

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