Janifha Evangeline, Assistant Editor, India Pharma Outlook
Owing to the direct impact of its products on public health & safety, the pharma sector operates within a highly regulated environment. To ensure that medications are safe, effective as well as manufactured as per the stringent quality standards, regulatory compliance is highly crucial. A complex web of national, regional as well as global regulations should be navigated by pharma companies which cover all phases of drug development right from research & clinical trials to production, marketing as well as post-market surveillance.
The role of Regulatory Affairs becomes pivotal in this context. While facilitating the approval as well as marketing of new drugs, regulatory affairs professionals are tasked to ensure that pharma companies comply with all the relevant regulations. A well-structured regulatory strategy can help in improving compliance, streamline the product approval processes and most importantly alleviate the penalties, recalls or cost delays. In this article let us look at how pharma companies can improve compliance through effective Regulatory Affairs strategies.
What is required to guide a drug through the approval process as well as maintaining compliance throughout the lifecycle of the drug is a well-planned regulatory strategy. And, this strategy must be aligned with the overall business goal of the organization while considering the unique regulatory requirements of every market. Some of the key components of an effective regulatory strategy comprise Early Regulatory Engagement, Regulatory Risk Management, and Global Regulatory Coordination.
Managing regulatory submissions, especially in a global context, requires a combination of meticulous planning, cross-functional collaboration, and a deep understanding of regulatory landscapes.
"The pharmaceutical industry faces several key challenges in adopting and implementing new technologies. One major hurdle is the stringent regulatory environment. Ensuring compliance with global standards and obtaining necessary approvals can be a time-consuming and costly process," says Dr. Saloni Wagh, Director, Supriya Lifescience.
"Additionally, integrating advanced technologies such as artificial intelligence and automation requires substantial investment in both infrastructure and skilled personnel," she adds.
While compliance is not the only responsibility of the Regulatory Affairs departments, it needs collaboration among numerous functions that are within the company. Cross-functional teams that include RA, quality assurance, manufacturing, clinical development, as well as marketing ensure that the regulatory requirements are all integrated into various phases of product development.
"In an ever-evolving landscape of health threats, as seen through the ongoing battle against emerging infectious diseases, safeguarding pharmaceutical quality gains paramount significance. Regulatory agencies must proactively establish swift response protocols," says Raheel Shah, Business Development Director, BDR Pharmaceuticals.
RA Professionals must work closely with R&D teams in order to make sure that clinical trials are designed for meeting regulatory requirements. These comprise choosing appropriate end points, making sure of patient safety, as well as collecting the required data for submission to regulatory authorities. Involving RA in the early development phases can decrease the necessity for additional studies or data collection later, and this will result in the speeding up of the process of approval.
The digital transformation of the pharmaceutical sector provides opportunities for improving compliance via the use of advanced technologies. Technology can be leveraged by Regulatory Affairs for improving data management, streamline submissions as well as ensure ongoing compliance with regulatory requirements.
Regulatory authorities are adopting electronic submission systems increasingly which include the FDA’s ESG and EMA’s eCTD submission system. Implementing electronic document management systems can facilitate organizations to organize, track as well as submit regulatory documents efficiently. These systems enable real-time tracking of submission status, automated notifications of regulatory updates as well as version control. Technology can improve compliance and augment the approval process by decreasing manual errors & enhancing submission accuracy.
Compliance does not end once a drug is approved, organizations should continue to monitor the safety as well as the efficacy of their products throughout the lifecycle. Also, post-market surveillance is an important component of the regulatory compliance and the failure of complying with post-market needs which can lead to penalties, withdrawal of marketing authorization and product recalls.
Regulatory authorities would impose post-approval commitments on Pharma companies which include conducting additional studies or even monitoring specific safety concerns. Organizations should make sure that these commitments are met for maintaining their marketing authorization. Failure of complying with post-approval requirements will result in regulatory actions.
Ongoing training and development are highly essential to maintain compliance in the ever-evolving regulatory segment. Both the regulatory affairs professionals as well as other key stakeholders within a company must obtain regular training on new regulations, industry best practices as well as guidelines.
Organizations must adopt the culture of continuous improvement by regularly reviewing their regulatory processes as well as identifying areas for improvement in addition to training. This can comprise conducting internal audits, soliciting feedback from regulatory authorities as well as benchmarking against industry standards.
Lastly, by fostering a commitment to continuous improvement, pharma companies can make sure their regulatory strategies can be effective in improving compliance over the long period.
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