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 Update Date  July 13, 2022
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Summary of Good Regulatory Practices

A fundamental role of presidency is to shield and promote the health and safety of the general public, including providing health care. A well-functioning health care system requires available, affordable medical products that are safe, effective and of consistently assured quality.

The medical products sector is one in all the foremost regulated of all industries, because of the impact of the various range of medical products on health, the difficulty in assessing their quality, safety and efficacy or performance1 and the complexity of their development, production, supply and surveillance. It is therefore essential that the interests and safety of the general public be entrusted to a regulatory body liable for ensuring that only products in legal trade are available which marketed products are safe, perform as claimed and are of assured quality.

Regulatory authorities have a obligation to confirm that they regulate in an exceedingly manner that achieves public policy objectives. A coherent legal framework should be established and implemented that gives the desired level of oversight while facilitating innovation and access to safe, effective and good quality medical products. The framework should even have the required flexibility and responsiveness, particularly for managing public health emergencies, addressing new technologies and practices and promoting international regulatory cooperation.