What does PMC mean in BRITISH MEDICINE
Postmarketing Commitment (PMC) is an agreement between a drug manufacturer and the government that outlines a set of actions the manufacturer is to carry out post-approval, usually concerning drug safety. PMCs are typically used when a medical product has not been adequately tested for certain risks in the pre-approval process. PMCs are designed to ensure that companies continue to track and monitor their products after they have been approved and marketed. By doing so, the company can identify any hazards associated with its products and ensure that appropriate warnings and information are provided to consumers.
PMC meaning in British Medicine in Medical
PMC mostly used in an acronym British Medicine in Category Medical that means postmarketing commitment
Shorthand: PMC,
Full Form: postmarketing commitment
For more information of "postmarketing commitment", see the section below.
What does PMC Mean?
PMC stands for Postmarketing Commitment. A PMC is an agreement between a pharmaceutical company and the government that outlines how the company will collect data on, monitor, or report on a drug or medical device after it has been approved by the FDA. This agreement is designed to ensure that companies continue to track and monitor their products post-market approval in order to better understand any potential safety risks associated with them. The data collected from these postmarketing activities will be used by regulatory authorities in their assessment of product safety when determining whether new indications for use should be approved.
What is included in a PMC?
The details of what is included in each individual PMC can vary depending on the circumstances but typically include commitments such as conducting phase 4 clinical trials; adding new labeling or changing existing labeling; providing additional medical device accessories or changes; issuing Risk Evaluation Mitigation Strategies (REMS); collecting adverse event data; monitoring pediatric use, pregnancy outcomes, adherence, effectiveness, dosing accuracy, etc.; conducting epidemiologic studies; participating in postmarket surveys or registries; conducting long term follow up studies; communicating risk information to patients/consumers/healthcare professionals; developing educational materials; participating in external scientific discussions related to product benefits and risks etc..
Essential Questions and Answers on postmarketing commitment in "MEDICAL»BRITMEDICAL"
What is a PMC?
A postmarketing commitment (PMC) is an agreement between the Food and Drug Administration (FDA) and a pharmaceutical company to conduct additional clinical trials or laboratory studies after a drug has been approved and placed on the market. PMCs are not mandatory, but they are intended to provide further evidence for drug safety, effectiveness, efficacy, labeling accuracy, or other factors relevant to the public health.
When will postmarketing commitments be required?
Postmarketing commitments are usually requested by the FDA during the review of a new drug or biologic application when available data are insufficient to assess safety or effectiveness of that product.
What types of studies do postmarketing commitments involve?
Postmarketing commitments can involve any number of studies including clinical trials, observational studies, epidemiological studies, validation and testing of analytical methods used in manufacturing process control systems, submission of pharmacovigilance plans or data collection activities.
Who is responsible for completing postmarketing commitments?
The sponsoring company is ultimately responsible for completion and compliance with all postmarketing commitments. The FDA may work with the sponsoring company through the Clinical Trials Network (CTN) to coordinate activities associated with postmarketing commitments.
How long does it typically take to fulfill postmarketing commitment obligations?
It depends on the type and complexity of each commitment but fulfilling these obligations can take several years or more depending on circumstances.
Are there any penalties for not fulfilling postmarketing commitment obligations?
Yes. Failure to fulfill these FDA requirements may result in regulatory action such as temporary suspension of marketing authorization until requirements are fulfilled or permanent withdrawal from the market if such requirements fail to be completed in due time and/or with satisfactory results.
How can I track updates related to my post-marketing commitment obligations?
The FDA provides an online system called eSubmitter which allows companies to electronically submit information pertaining to their upcoming clinical trials, as well as complete other tasks associated with their post-marketing commitment agreements. Additionally companies may use other electronic tracking systems they find useful such as electronic calendar reminders.
Do I need to report adverse events related to products subject to postsales surveillance?
Yes, if your product is subject to postsales surveillance you must report any serious adverse event within 15 days from receipt of knowledge in accordance with 21 CFR 314 Subpart E - Postapproval Reporting Requirements for Drugs Approved Under Section 505(b)(1). Additionally you must also report any non-serious adverse event within 15 days from receipt of such knowledge in accordance with 21 CFR 314 Subpart G - Reportable Events for Human Drug Products Approved Under Sections 505(b)(2).
Final Words:
In conclusion, PostMarket Commitment (PMC) is an important agreement between pharmaceutical companies and governing bodies that helps ensure ongoing safety evaluation of approved medications and devices following market approval. It outlines specific commitments that manufacturers must adhere to after getting approval for their products so as to assess potential risks related with their use. This closely monitors products so that timely warnings may be issued if needed to alert healthcare providers and consumers about any associated hazards which might arise during marketing use of those medicines/devices.
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