In the world of pharmaceutical industry, Marketing Authorization term is being used for formal approval process, by which various regulatory agency grant permission for the commercial distribution and sale of a Pharmaceutical Product. Marketing Authorization is an official document issued by the regulatory agency for the purpose of marketing of a product after evaluation for Quality, Safety and Efficacy.
What is Marketing Authorization in Pharmaceutical Industry?
The Pharmaceutical Regulatory Agencies are responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). The process for having marketing authorization for any pharmaceutical product is a critical and rigorous step. Which goes with the concept of Product Lifecycle management Process, i.e. from development stage to commercialization stage of pharmaceutical products and further monitoring.
These Marketing Authorization approval steps involves the submission of wide-ranging data and information about the subjected product's safety, efficacy, and quality, gathered through preclinical and clinical trials, as well as detailed information about the manufacturing processes.
Key components of the Marketing Authorization process
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| Fig. 1: Key components of the Marketing Authorization process |
Pre-clinical and Clinical Trials:
Before seeking marketing authorization, pharmaceutical companies conduct extensive preclinical studies and clinical trials to gather data on the safety and efficacy of the drug. This involves testing the drug in the laboratory and on animals (preclinical) and then in humans (clinical). These trials form the scientific backbone, providing essential insights into the safety, efficacy, and overall quality of a product before it reaches the hands of healthcare professionals and patients.
Marketing Authorization Application (MAA):
Submitting an MAA is a strategic and meticulous process, often involving collaboration with regulatory experts. Once the necessary data has been collected, a pharmaceutical company submits a Marketing Authorization Application to the relevant regulatory agency. The application includes detailed information about the drug's composition, manufacturing process, proposed labelling, and the results of preclinical and clinical studies. This comprehensive application is a formal request submitted to regulatory authorities, seeking approval to market and distribute a pharmaceutical or biotechnological product.
Regulatory Review:
Once Marketing Authorization Application (MAA) is submitted, the MAA undergoes a rigorous review process by regulatory authorities, where experts assess the provided data to ensure the product meets the necessary standards for safety, efficacy, and quality. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in Europe, or other national regulatory bodies, review the MAA to ensure that the drug is safe, effective, and of high quality. This review involves a thorough assessment of the submitted data.
Approval or Rejection:
Based on the regulatory review, the regulatory agency makes a decision to either approve or reject the marketing authorization. If approved, the pharmaceutical company is granted permission to market and sell the drug for the specified indications. If the regulatory authorities identify concerns related to safety, efficacy, quality, or compliance with regulatory standards, they may reject the MAA. Rejections can result from inadequacies in study design, data quality, manufacturing processes, or failure to address regulatory queries adequately.
In some cases, regulatory authorities may provide conditional approval, allowing market entry under certain conditions. This is often based on a commitment from the applicant to provide additional data post-approval. If an MAA is rejected, applicants typically have the option to appeal the decision or resubmit the application with additional data addressing the concerns raised during the review process.
Post-Marketing Surveillance:
Even after marketing authorization is granted for pharmaceutical product, ongoing monitoring of the drug's safety and efficacy continues through post-marketing surveillance. This helps to identify and address any previously unrecognized issues that may arise once the drug is in widespread use. It is an ongoing process designed to monitor the safety, efficacy, and overall performance of the authorized product in real-world conditions. Ensuring ongoing compliance with regulatory requirements is a key aspect of Post-Marketing Surveillance.
If we see the validity of Marketing authorisation as per various Pharmaceutical regulatory agencies is valid for a period of 5 years and subjected for renewal after this period. However, in the European Union, once the renewal has been done, the marketing authorisation shall remain valid for an unlimited period, unless the competent regulatory authority decides otherwise.
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