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Jun 14, 2023
Regulatory Affairs
Regulatory Affairs: What is it and What does it Entail?
Navigating the complex landscape of regulations and compliance is a key concern for businesses operating in any industry. But it is extremely important in the pharmaceutical industry as the medical devices, therapeutic products, and services used can have detrimental effects on human health.
In Singapore, the role of regulatory affairs takes centre stage in ensuring adherence to stringent guidelines and facilitating smooth market access in the healthcare industry. But what exactly does it entail and what should medical and pharmaceutical businesses know about it? Find out more.
What is Regulatory Affairs?
Regulatory affairs refers to the field of activities and processes that deal with making sure businesses and products across various industries meet the necessary compliance and regulatory standards set by government agencies in Singapore. In the medical and pharmaceutical industry, regulatory affairs management refer to the development, registration, and marketing of pharmaceuticals, medical devices, biologics, and other healthcare products while ensuring their safety, efficacy, and quality. This plays a crucial role in safeguarding public health, consumer protection, and maintaining industry standards.
Key Aspects of Regulatory Affairs
1. Regulatory Strategy
Regulatory affairs management requires strategising work to make sure that pharmaceutical companies are able to meet regulatory requirements. It involves understanding the guidelines to comply with, the actionables, and formulating a plan to ensure compliance. Businesses have to assess the product’s intended use, identify potential regulatory hurdles, and devise strategies to address them effectively.
2. Regulatory Submissions
In order for businesses to market and sell their pharmaceutical products in Singapore, they’ll need to submit a series of documents to register these products and seek approval for marketing authorisation from the Health Sciences Authority (HSA). Regulatory submissions involve preparing and submitting these documentation and ensuring that the items adhere to health product regulations in Singapore. The submissions should include detailed information, such as the product’s composition, manufacturing process, preclinical and clinical data, and labelling information.
3. Compliance and Quality Assurance
One of the key considerations in regulatory affairs management is the safety and quality of medical and pharmaceutical products in Singapore. Compliance with regulatory requirements is of utmost importance, and businesses are required to monitor regulatory updates, conduct internal audits, implement corrective and preventive actions, and address any compliance gaps identified to provide safe products.
Learn More: 7 Steps To Solve Regulatory Issues
4. Risk Assessment
Another critical aspect of regulatory affairs is risk assessment, which is crucial to minimise potential patient harm and ensure product safety. It involves conducting risk assessments, such as hazard analysis, and devising risk mitigation strategies throughout the product lifecycle—development, manufacturing, and post-market stages.
5. Post-Market Surveillance
Post-market surveillance involves monitoring the safety and quality of therapeutic products after they have been approved and made available on the market. These surveillance systems can include processes for adverse event reporting, complaint handling,being responsive to safety signals and reviewing risk management plans (RMP) . They ensure that any potential safety concerns or issues are promptly addressed through appropriate actions, such as product recalls or labelling updates.
6. Regulatory Intelligence
Keeping up-to-date with regulatory developments is crucial in regulatory affairs. Changes in regulations, policies, and guidelines issued by government agencies such as HSA, must be monitored, and actions must be taken to ensure compliance to these new updates.
Regulatory affairs is indispensable in the healthcare and pharmaceutical industry in Singapore. From developing strategies to ensuring compliance, these procedures ensure that products are kept safe, of quality, and effective.
The Reg Consultants Pte Ltd (TRC) provides regulatory consulting services in Singapore to assist local and overseas pharmaceutical and medical companies register their products locally. Get in touch with us for more assistance today.
