A professional working in regulatory affairs has the task of ensuring that all kinds of products from cosmetics to pharmaceuticals to human and veterinary medicines meet legislative requirements. When it comes to vaccines, this process means reviewing emerging vaccines for safety, efficacy, and quality.
The development of vaccines under normal circumstances requires trials involving thousands of people, and can take many years to approve under a stringent review process. In the face of COVID-19, many vaccines are currently being developed at a much quicker rate, presenting complicated challenges for both the manufacturers of these new products as well as the regulatory authorities responsible for their oversight. Even in the face of these challenges, though, authorities remain steadfast in their commitment to public safety.
To understand more about what’s involved in regulating new vaccines, let’s take a closer look at the process.
Scientific and Clinical Evidence Comes First
Vaccines are categorized by the Canadian Food and Drug Act as biologic drugs, due to the fact that they come from living organisms. This makes these drugs more variable than chemical drugs, necessitating more specialized procedures in how they are manufactured and controlled. The expertise of regulatory authorities is needed to oversee these procedures.
The science of developing vaccines is based on clinical evidence taken from a review of manufacturing processes and human trials. The results of this review process must prove the drug’s safety, efficacy, and quality.
In Canada, a manufacturer wishing to develop a new vaccine must start this process by:
- Filing a Clinical Trial Application with Health Canada’s Biologics and Radiopharmaceutical Drugs Directorate.
- Filing a New Drug Submission when enough evidence has been gathered to prove the vaccine’s safety and efficacy. This next step gives Health Canada more details about the method of manufacture, the facility where the vaccine is being developed, and quality controls that have been put in place.
Training for Careers in Regulatory Affairs Helps with Oversight on Safety, Efficacy, and Quality
After a manufacturer files an application, Health Canada must rule out safety concerns by conducting a thorough clinical review of the vaccine in question. People with careers in regulatory affairs have the level of training needed to assist Health Canada in performing this review, which must confirm the following:
- The vaccine is capable of prompting an adequate immune response in those vaccinated
- The benefits of using it outweigh the risks
- Its efficacy in trials for protecting against a disease compared with no vaccine
During the development process, Health Canada can also check on the quality of the vaccine in question by visiting the manufacturing facility anytime they wish. These visits are important for assessing the quality of the manufacturing process and for ensuring required quality controls are being carried out onsite.
Authorizing the Vaccine Is the Final Phase
Those training in regulatory affairs programs will no doubt be interested in knowing what leads to the final approval of a new vaccine. This last phase of a vaccine’s development is the one that can benefit millions of people around the world for many years to come, if the checks and balances up to this point have been taken diligently.
To demonstrate that the vaccine has been approved for sale in Canada, Health Canada will issue a Notice of Compliance (NOC) and a Drug Identification Number (DIN). Once a vaccine has been approved for sale, regulatory authorities will continue to assist Health Canada in supervising its mass production and quality control for ongoing monitoring of safety and efficacy.
The process for approving a new vaccine is long and arduous, but absolutely essential for preventing serious or unexpected reactions in populations where it will be administered. Regulatory affairs authorities are key team members in performing the necessary steps of oversight required in the development of vaccines and the ongoing monitoring of those that eventually make it to market.
Are you interested in receiving specialized training in pharmaceutical regulatory affairs?
Contact AAPS today for more information on their Regulatory Affairs program!