NeuAge Institute (NAI)

Post-Approval Compliance in Pharmaceutical Regulatory Affairs

When it comes to pharmaceutical regulations, there’s a lot more to compliance than getting a drug approved for production. It’s essential to ensure compliance throughout the entire drug lifecycle–including in the post-approval stage. 

After a pharmaceutical product is approved, there are a whole host of activities that need to be covered in order to start selling a product. This includes labeling, marketing, advertising, and distribution, as well as ongoing compliance, such as responding to any reported problems with the drug and documenting any changes to it.

As a regulatory affairs professional, you’ll need to understand the key elements of post-approval compliance to ensure that an approved drug can continue to be used safely and effectively by the public. To get you started, here’s a brief overview of post-approval activities in the pharmaceutical industry. 

Promotional Labeling and Advertising

Marketing for pharmaceutical drugs is not the same as any other consumer products or services. The FDA has strict regulations around prescription drug advertisements and promotional labeling.

In the past, confusion with packaging and labeling has led to a number of medication errors. As such, the FDA imposes requirements around labeling to ensure the information is accurate and clear to physicians and patients. This includes reviewing the content of the prescribing information, the proper name, the brand name, and the format of carton and container labels. At the same time, there are limitations on the way approved drugs are advertised. While advertisements can be found in newspapers and on the internet or television, manufacturers are prohibited from advertising unapproved uses of their products

Students at NeuAge Institute will learn about other FDA requirements for drug labeling, advertising, and promotion in the U.S. through our Pharmaceutical Regulatory Affairs program. This will prepare you to monitor the safety and transparency of new drugs on the market. 

Labeling is crucial to ensure product information is clear and accurate.

Dealing With Adverse Events and Recalls

With the release of any new pharmaceutical product, there is always a risk of unforeseen effects. However, some of those effects can prove to alter the safety and approval of the drug. It’s the job of regulatory affairs professionals to ensure that complaints and problems are reported and that the proper protocol is followed for reviewing the drug. 

The FDA has several programs, such as MedWatch, that allow manufacturers, health professionals, and consumers to report problems associated with approved drugs, including life-threatening events. Those reports will be submitted to regulatory agencies in the pharmaceutical industry, who will then evaluate the product’s safety. In some cases, reports of adverse effects can lead to changes in the product’s label–or even the complete withdrawal of the product from the market. 

Complaints or reports can lead to product changes in the pharmaceutical industry.

Monitoring Changes to Products in the Pharmaceutical Industry

Sometimes, changes are made to a pharmaceutical product after it has been approved for market release. This may be done in response to new research, regulations, or adverse events. In that case, all changes must be evaluated to assess their impact on the quality, safety, and efficacy of the product. This is essential to ensure ongoing compliance with an existing product. All changes must be documented properly, and some may require approval from a regulatory agency beforehand. 

The Regulatory Affairs Certification program at NAI will cover all the key post-approval compliance activities, including discontinuation or withdrawal, changes with potential impact on identity, quality, purity, or safety, complaint handling and monitoring, and more. With knowledge of current industry regulations, you can play a part in advancing the safe distribution of new drugs on the market. 

Are you looking to earn your regulatory affairs certificate?

Contact NeuAge Institute to learn more about our program.

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