Understanding the Approval Process for Health Products

Health product approval is not as easy as one would think. It’s overwhelming, especially in a country as big and complicated as Australia, where products need to be researched and sanctioned first by the TGA before they even reach the market. Be it a manufacturer, a distributor, or a healthcare professional, this process is invaluable to ensure your products are safe and of quality and reach the consumer’s hands. 

In this blog, we will know the steps included in the approval process, focusing on key points that could help you launch your health product successfully in the market.

Understanding the Approval Process?

This just involves a set of procedures that health products should undergo before they can be legally marketed and sold in the marketplace. In this case, it ensures that the products are safe, effective, and of good quality.

Every country has its unique regulatory authority to oversee this process. For example, in Saudi Arabia, the Saudi Food and Drug Authority (SFDA) regulates health products in the country, such as drugs, medical devices, and dietary supplements.

Step 1: Pre-Submission

This is the preparation involved before making your product ready for approval. It involves all the relevant documents, including:

Product Information: Description of the product in terms of how you formulated it, what it is composed of, and even what you intend to do with it.

Clinical Data: Evidence that it is safe and effective for human use based on clinical studies or trials.

Manufacturing Information: All the details regarding manufacturing control measures implemented and whether the facility is certified.

All information provided should be as detailed and accurate as possible because an error in any of them can result in postponement or disapproval of your application during the processing stage.

Step 2: Application Submission

Upon gathering all the details required for the preparation of your application, you then submit your application to the relevant regulatory body. In Saudi Arabia, this is referred to as applying for SFDA registration. This will always typically comprise of the following:

Cover Letter: Brief background of the company and introduction of the product to be submitted.

Application Form: The form on which the vital information regarding the product is being obtained.

Supporting Documents: All the information collected during the preparation stage, like clinical data and manufacturing details.

Step 3: Review and Evaluation

This is because the regulatory authority checks your application once you submit it. In this case, given that there must be a check on the safety, efficacy, and quality of the product concerned, the process could take ages. As such, they can:

Conduct Scientific Review: They examine clinical data and supporting documents to establish that they meet certain standards relating to safety and efficacy.

Quality Control: Checking the quality measures for quality assurance by manufacturing processes.

Stage 4: Inspection

The regulatory authority may need to inspect your manufacturing facility. The review will make sure that your facilities or premises possess GMP and are on par with all specified regulatory requirements. Areas inspected include:

Facility Hygiene: The manufacturing site is hygienic and appropriate for manufacturing healthy foods.

Quality Control Practices: You have the right quality control methods implemented.

Documentation Procedures: You maintain all procedures and documentation in written records.

Stage 5: Approval and Marketing Authorization

Once your application undergoes review and inspection, it will be approved and given marketing authorization. This means that once it is approved, your product is ensured to be sold and marketed legally in the market. Don’t forget that you should continue monitoring its safety and efficacy even after its approval.

Step 6: Post-Market Surveillance

It involves monitoring the performance of your product in the market after it has been approved. Often, it is the stage through which the post-launch problems could be identified, presenting any critical elements included under post-market surveillance as follows:

Adverse Event Reporting: Tracking and reporting any adverse events or side effects associated with your product.

Adverse Event Reporting: Any adverse events or side effects encountered concerning your product.

Periodic Safety Updates: Report to the regulatory authority on the safety and efficacy of the product at regular intervals.

The knowledge of the approval process for health products would be the first help for a person in the industry. With the right understanding, one can move through this process much more smoothly and ensure the passing of that product through all the necessary safety and quality checks.

Keep in mind that this process varies significantly from one country to another, so it’s best to contact your country’s relevant regulatory authority for a more specific guide. The more prepared and diligent you are, the greater the possibility of successfully launching the health product in the market with results regarding health and well-being for consumers.