World Health Organisation (WHO) has now issued guidance on good regulatory practices (GRP) for medical products. The norms are for national regulatory authorities (NRAs), laboratories, manufacturers, academia researchers and stakeholder organizations. These segments will have to revert with the comments before December 2016.
GRP is built on transparency and good governance to ensure making public confidence in health products. The national regulatory systems, and international regulatory cooperation programmes, remain relevant, current and flexible as technology evolves and unforeseen needs and emergencies occur, stated WHO in its norms.
The document, according to WHO will be considered by the expert committee on biological standardization (ECBS) and the expert committee on specifications for pharmaceutical preparations (ECSPP).
It presents the desirable practices of regulatory systems for medical products. The Part 1 presents nine principles on which regulatory systems may be established. These principles are: legality, impartiality, consistency, proportionality, flexibility, effectiveness, clarity and transparency.
NRAs should be competent to issue regulations that impose or prohibit certain conduct, as well as other non-prescriptive rules that aim to guide actions, provide recommendations. The regulatory authority should have the resources and powers necessary to take timely and effective action by itself to enforce regulations.
For instance, if the customs authority suspects that an imported medical product is nonconforming, the responsible NRA should have the power and resources to perform the necessary investigations and launch appropriate actions. Similarly, NRAs should be resourced and empowered to investigate and take appropriate actions against physicians responsible for noncompliant clinical trials. Where there is no regulatory system in place, for medical products, then measures based on a country’s existing legal framework should be taken in order to address the immediate necessity of protecting public health. This could include consumer protection or imports.
Regulations and regulatory decisions should be impartial in order to be fair and to avoid conflicts of interest. It should support and complement, and not conflict with, existing regulations. Medical product regulations must continue to evolve to reflect advances in science, standards of care and technology. The compliance measures should be proportionate to the risk and severity of infractions. The norms should be sufficiently flexible to allow for a rational response to changes in the regulated environment. The language of regulation should be descriptive and not prescriptive and should allow for alternative approaches that achieve the same result. There should be flexibility to respond to emergencies, shortages of medicines, and use for humanitarian purposes.
The effectiveness of a regulation should be periodically assessed using performance-based indicators. Successful establishment of regulatory controls on medical products depends on comprehensive early- stage planning for implementation, noted WHO in its draft norms.
Efficient regulatory requirements and practices will be seen by the public to produce benefits that justify their costs Regulations should not hinder patients’ access to necessary, appropriate and affordable health technologies that address public health needs. Because of the nature of medical products and their intended uses, medical product regulations are necessarily rigorous. For many medical products, the costs and risks of development are high, stated the guidance document.