Core functions specific to vaccines
The NRA is usually the main institution mandated to regulate medical products, including vaccines. It has the aim of ensuring the quality, efficacy and safety of the product as well as ensuring the relevance and accuracy of product information. A sustainable, well-functioning regulatory system will ensure an independent and competent oversight of medical products.
NRA functions relating to vaccines
WHO defines a national regulatory system (RS) in terms of the enabling legal system and infrastructure, common regulatory functions and non-common regulatory functions (see figure below) that apply across medical products life cycle starting from the research and development (R&D) through to pre-clinical; clinical; production and quality control; commercialization and sale; and other post marketing activities.
Seven common functions apply to the regulation of all medical products: registration and marketing authorization (MA), vigilance (VL), market surveillance and control (MC), licensing establishments (LI), regulatory inspection (RI), laboratory testing (LT), and clinical trials oversight (CT).
In addition, a number of non-common functions apply to certain medical products. Non-common functions include NRA lot release (LR) for vaccines, plasma derived medicinal products (PDMD) and blood related in-vitro diagnostics.
As far as vaccine regulatory system in concerned, in addition to the national regulatory system (RS), there are eight (8) core regulatory functions (as explained in the below table), which between them cover the whole product life cycle of medical products.
|NRA functions relating to vaccines|
Registration and marketing authorization
|Marketing authorizations (also known as product licensing or registration) are the procedures for approval of a medical product for marketing after it has been evaluated for safety, efficacy and quality of the product, and the appropriateness of the product information.|
|Vigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medical product-related problems.|
Market surveillance and control
|An NRA’s market surveillance and control function activities are primarily concerned with control of import activities; prevention, detection and response to substandard and falsified (SF) medical products; quality monitoring throughout the supply chain; and control of promotional, marketing and advertising activities.|
|The NRA is responsible for ensuring that all establishments throughout the medical products supply chain are licensed to undertake the respective activities (e.g., manufacturing, distribution, wholesale, retail if applicable).|
|Regulatory inspections ensure that operations are carried out in accordance with approved standards, norms, and guidelines and are in compliance with the national medical products legislation and regulations. These, in turn, should be consistent with WHO recommendations and other internationally recognized guidelines.|
|The laboratory testing regulatory function is intended to ensure that the NRA is able to assess the quality of medical products by performing quality tests when needed.|
Clinical trials oversight
|Clinical trials oversight is aimed at protecting the safety and rights of humans participating in clinical trials, ensuring that trials are adequately designed to meet scientifically sound objectives, and preventing any potential fraud and falsification of data.|
National regulatory authority lot release
|Lot release (also called official authority batch release) is a non-common regulatory function that does not apply to all medical products. Rather, it applies only to some specific products (e.g., vaccines), verifying consistency of the safety and quality of different batches of vaccine coming off the production line.|
The above mentioned functions may be undertaken by one or more institutions reporting to the same or different senior official. When distributed across institutions, the degree to which they communicate and have clearly defined mandates defined in law, determines in large part how well the designated regulatory bodies perform as an integrated system.