Key Sections
What is Compliance Management?
Compliance Management in Regulated Industries
Tackling Global Health Regulations
Summary of Chapter
- Compliance management is the process by which organizations ensure they follow all relevant laws, regulations, standards, and internal policies
- Compliance control is vital in regulated industries where strict adherence to regulations is essential to protect public safety and build trust with customers, regulators, and stakeholders
- Multinational companies must navigate global health regulations set by authorities including having a regulatory affairs departments, engaging in product development and compliance control, and ensuring compliance through regulatory submissions and approvals to name a few
- iNova Pharmaceuticals improved their quality assurance and speed-to-market by implementing GlobalVision’s proofreading software to aid in their compliance management processes
What is Compliance Management?
Compliance management refers to how organizations ensure that they are adhering to all relevant laws, regulations, standards, and internal policies that apply to their business operations.
This can involve a series of activities, compliance systems, and processes designed to identify and mitigate risks related to non-compliance. Through the implementation of the latter, organizations can avoid legal penalties, financial losses, and reputational damage.
Compliance Management in Regulated Industries
While compliance management, or compliance control, is essential in many industries, it is especially crucial for regulated industries where adherence to strict regulations is crucial.
Regulated industries such as pharmaceuticals and CPG are subject to strict laws and regulations designed to protect public safety, health, and the environment.
Non-compliance can lead to severe consequences while effective compliance management helps safeguard companies and helps them avoid these risks by ensuring they consistently meet regulatory requirements.
For perspective the average cost of compliance came in at $5.47 million, while the average cost of non-compliance was $14.82 million.
Compliance management also builds trust with customers, regulators, and stakeholders, ensuring that the company operates ethically and responsibly, which is particularly important in industries where safety and reliability are paramount for consumer protection.
Tackling Global Health Regulations
Multinational companies have the responsibility of adhering to regulations that have been set by health authorities such as the FDA (U.S. Food and Drug Administration), Health Canada, and the European Commission.
Compliance with these authorities is essential for getting quality products to market quickly while simultaneously ensuring the safety of consumers.
Here are some ways in which multinational companies navigate the regulatory landscape and tackle global health regulations with greater ease:
1. Regulatory Affairs Departments
Multinational corporations maintain large regulatory affairs departments that specialize in navigating the complex regulations of different countries.
These teams are responsible for ensuring that products meet the requirements of health authorities before they are introduced to the market.
These departments often include both global regulatory strategists and local experts who understand specific regional requirements. This dual approach allows companies to tailor their strategies to different regulatory environments.
2. Product Development and Compliance Control
During the product development phase, multinational corporations engage with health authorities early and often. This might include submitting pre-clinical data, clinical trial designs, and other relevant information to regulators to ensure that the product development aligns with regulatory expectations.
For pharmaceutical products in particular, companies must conduct rigorous clinical trials that meet the standards set by regulators. The results of these trials must demonstrate safety and efficacy before a product can be approved.
For food products, companies must ensure that nutritional content, health claims, allergens, and labeling comply with regulations. For instance, the European Commission has strict rules about health claims that can be made on food products. This includes that health claims must be based on scientific evidence, they must be approved health claims only, and no claims about preventing, treating, or curing diseases are permitted.
3. Regulatory Submission and Approval
Companies prepare comprehensive dossiers that include all necessary scientific data, manufacturing information, and labeling details. These dossiers are submitted to regulatory bodies like the FDA, Health Canada, and the European Commission for review.
There is often a period of interaction with regulators where questions are answered, additional data is provided, and potential issues are resolved. Companies may engage in formal meetings or submit additional documentation as requested by the regulators.
Once the dossier is reviewed, regulators will grant approval, request further information, or deny the application. This process can vary in length depending on the complexity of the product and the regulatory environment.
4. Post-Market Surveillance and Compliance
After a product is approved and launched, multinational corporations must continue to monitor its safety and efficacy. This includes reporting adverse events, conducting post-market studies, and ensuring ongoing compliance control with regulatory standards.
Regulatory bodies may conduct audits and inspections to ensure that products remain compliant with their regulations. In these cases, corporations must be prepared to demonstrate ongoing compliance with all applicable regulations.
If a product is found to be non-compliant or poses a safety risk after it has been marketed, the company must work with regulators to recall or correct the product. This can include issuing public warnings, withdrawing products from the market, or reformulating the product.
5. Adaptation to Regulatory Changes
Regulatory environments are constantly evolving, and multinational companies must adapt to changes in regulations. This might involve reformulating products, updating labeling, or modifying production processes to comply with new standards.
Companies often engage proactively with regulators to influence the development of new regulations. This might involve participating in industry groups, submitting comments on proposed regulations, or working directly with regulators to ensure that new rules are feasible for the industry.
Case Study: Using Compliance Management Systems in Pharmaceuticals
In late 2017, iNova Pharmaceuticals' quality teams underwent organizational changes, gaining greater control over their quality assurance. Discovering GlobalVision’s proofreading software, they implemented it in early 2018, regaining internal ownership and total control of their artwork revisions.
This implementation allowed them to ensure first-hand the accuracy of their files which ultimately led to faster and higher quality revisions and control, as well as increased their overall speed-to-market for new product launches.
The software is used daily to run approvals of artwork at the final print-proof stage, and a review of the manufacturer’s file is done to ensure they can go to production, ultimately ensuring a swift time-to-market for products.
It is also used to verify barcodes and ensure they are accurate and compliant. This is a critical feature for iNova’s quality team, as products are not accepted if the barcodes do not pass the compliance regulations of health authorities.
Another crucial feature for iNova Pharmaceuticals is the software’s ability to select specific areas of a file that need to be inspected. GlobalVision allows users to pinpoint exact areas of a file, whether text or graphics, allowing for more detailed and precise inspections.
This feature has been particularly beneficial when working on files in foreign languages. As iNova distributes products to markets globally, quality teams must work on files in languages and alphabets that are not native to them. The feature allows for granular inspections of foreign content and more accurate visual inspections of graphic components within seconds.
As they are consistently reviewing and improving their processes, iNova Pharmaceuticals is in the process of implementing GlobalVision’s newest innovation in cloud-based proofreading software, Verify, to further drive speed and accuracy in their proofreading processes.
FAQs
What are key global health regulations that multinationals need to comply with in 2024?
In 2024, multinationals must navigate a complex web of health regulations that vary by country and region. These include stringent guidelines on data privacy in health records, pandemic response protocols, and the integration of AI in healthcare services.
How are multinational companies leveraging technology to manage compliance across different regions?
Multinational companies are increasingly using advanced compliance management systems, software and AI-driven analytics to ensure real-time tracking and adherence to global health regulations. These technologies help in automating compliance processes, reducing human error, and providing transparency across all operational regions.
What are the challenges faced by multinationals in maintaining compliance with global health regulations?
The main challenges include navigating varying regulatory standards across countries, staying updated with frequently changing laws, managing cross-border data transfers in compliance and dealing with the logistical complexities of ensuring compliance across multiple jurisdictions.
What role does corporate governance play in ensuring compliance with global health regulations?
Corporate governance plays a critical role in establishing a culture of compliance within multinational organizations. This involves setting up dedicated compliance teams, ensuring top-level oversight, implementing robust internal audits, and fostering communication between global offices to ensure consistent adherence to health regulations.
How do multinationals prepare for future changes in global health regulations?
To prepare for future changes, multinationals engage in proactive monitoring of regulatory trends, invest in ongoing training for compliance teams, and maintain close relationships with regulatory bodies. Scenario planning and regular compliance audits are also essential strategies for staying ahead of regulatory changes.
