Regulatory bodies (or regulatory agencies) in Life Sciences as we have come to know them have been around since the 1900’s, and they drive how we perform our work. This article is an introduction for those new to the industry and for others interested in the impact of these authorities on innovation.
What purpose does a regulatory agency serve?
Regulatory bodies, or agencies, are independent governmental bodies established by legislative acts in order to set standards in a specific field of activity, or operations, in the private sector of the economy and then to enforce those standards.
Naturally, as problems became more prevalent and complex in the 20th century, these agencies became necessary as a means for promoting fair trade and for protecting consumers. In Life Sciences, these agencies regulate how new products, i.e., drugs, biologics and medical devices, are tested in animals and in humans, and subsequently either rejected or approved for use.
Regulations over time have led to the development of GxPs, short for Good Practices, as controls/processes needing to be in place to ensure compliance with regulatory requirements. GxPs include mostly:
- GCPs – Good Clinical Practices (for proper conduct in collecting, cleaning, analyzing and reporting information from pre-clinical and clinical trials);
- GLPs – Good Laboratory Practices (for proper conduct of laboratories in maintaining standards and production of laboratory test results); and,
- GMPs – Good Manufacturing Practices (for proper conduct in the making of new drugs, biologics, and medical devices)
Regulatory agencies monitor product development activities (from discovery, manufacturing and marketing) inclusive if the execution of clinical trials to ensure that standard processes are being followed, and most importantly that patients are not being unnecessarily exposed to potentially harmful and/or ineffective products.
What are some examples of agencies globally?
US: FDA (the Food and Drug Administration)
In 1906, because of the passing of the Pure Food and Drugs Act, the Bureau of Chemistry became the FDA . The FDA is responsible for :
- Protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
- Regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.
- Advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.
- Ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.
EU: EMA (the European Medicines Agency)
Established in 1995, the EMA’s mission is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union (EU).
The EMA is responsible for:
- Facilitating development and access to medicines
- Evaluating applications for marketing authorization
- Monitoring the safety of medicines across their lifecycle
- Providing information to healthcare professionals and patients
Canada: Health Canada
Health Canada is responsible for Canada’s national health policy. They work with other federal health-related agencies including the Canadian Food Inspection Agency (CFIA) and the Public Health Agency of Canada (PHAC) to :
- Preserve and modernize Canada’s health care system
- Enhance and protect the health of Canadians
- Work in partnership with others
- Communicate health promotion and disease prevention
Japan: PMDA (the Pharmaceuticals and Medical Devices Agency)
Established in 2004, the PMDA is the government organization in Japan in charge of reviewing drugs and medical devices, overseeing post-market safety, and providing relief for adverse health effects .
How is our work influenced by these agencies?
Life Science companies need to be able to demonstrate regulatory compliance. This is determined via audits or inspections. Regulatory agencies can perform audits proactively by the company itself, using internal and/or contract auditors, and as part of a standard vendor qualification process when considering outsourcing with potential vendors.
The results of an audit highlight areas requiring further explanation/clarification to the auditor’s satisfaction. It will also highlight those that require improvement to address gaps or to ensure existing processes are fully compliant.
The results of the audit typically come in the form of a CAPA (Corrective Action and Preventative Action). The CAPA is an opportunity to understand the auditor’s feedback, identify and discuss any errors in observations, and ask any clarifying questions to ensure a proper approach and response to any remaining findings. Following the initial report, a CAPA response is expected to detail a plan/timeline addressing any audit findings.
In most cases, audit findings are manageable and addressed in short order. However, if it finds major and systemic findings that are not addressed in a timely fashion, the penalties can be quite severe and impact business.
Given the importance of regulatory compliance, Regulatory Affairs departments are established in Life Science companies to:
- Stay abreast of changes in legislation (rules and regulations) of drug research, manufacturing, and marketing
- Ensure effective communications internally to their organizations for assurance of regulatory compliance across all departments/functions
- Ensure effective communications externally with the regulatory agencies themselves to comply or show evidence of organizational regulatory compliance
So, regulatory agencies significantly impact how Life Sciences operate daily.
What role do they play in facilitating innovation?
As mentioned above, best practices and standard operating procedures aligned with regulations assist with compliance. Limiting ambiguity, variability, and changes to these processes facilitates compliance and gives well-trained staff the ability to respond with confidence to questions/concerns raised by staff and/or auditors.
Even the strongest and most established processes require periodic assessment and updates. However, similar to changes in software/hardware systems, the impact of these updates can be both time consuming and costly. Consider not only the process changes but also potential systems/data changes and certainly the retraining of staff. Consequently, process enhancements/revisions might be limited by some to only address high priority items (retroactive in nature).
Does this discourage innovation? Perhaps. Do regulatory agencies discourage innovation for fear that it could make compliance across industry organizations more difficult? By evaluating their websites and their proclamations and policies in action, it would appear they do encourage innovation.
While policing the industry is a large portion of what regulatory agencies do, innovation is vital to enhancing future discovery, development, and marketing. Over the past decade, agencies have declared their stance on innovation. Furthermore, the agencies listed above helped to spur innovation actively in the following ways :
- Publicly declaring innovation policies and strategies.
- Incentivizing innovations in the industry by offering “fast-track” or in the case of the FDA “breakthrough therapy” designations for therapies offering significant improvement over available therapies for patients with serious or life-threatening diseases.
- Collaborating and engaging with stakeholders, advisory panels, and task forces (including patients, drug development sponsors, and IT professionals) to learn about the impact of diseases on patients, and to gather input from industry experts in health information technology to pave the way for faster delivery of new products.
Regulatory bodies play a pivotal role in establishing fair trade and protecting the rights and safety of consumers. Most of their efforts historically focused on this. However, as technological advancements open new doors, regulatory agencies, to better serve patients, are open to and contribute to collaborative innovation efforts to speed new product approval and delivery while maintaining safety standards.