Significance of Regulatory Approval
Regulatory Approval refers to the essential process through which medical products must undergo thorough testing and governmental validation before they can be marketed. This includes several aspects such as evaluating clinical trial protocols, ensuring safety and efficacy of drugs, and certifying various medical technologies. Regulatory bodies, like the FDA, review data to confirm that products meet required standards before granting permission for public use, thereby safeguarding public health through their rigorous assessment processes.
Synonyms: Government approval, Certification, Authorization, Clearance, Sanction, Accreditation, Consent, Permission, Validation
The below excerpts are indicatory and do represent direct quotations or translations. It is your responsibility to fact check each reference.
The concept of Regulatory Approval in scientific sources
Regulatory Approval is a critical process ensuring that medical products undergo rigorous testing before they are allowed to be marketed, ensuring safety and efficacy for consumers.
From: World Journal of Pharmaceutical Research
(1) The process by which government agencies authorize the marketing of drugs or medical devices.[1] (2) The official sanction required from regulatory agencies before new products can be introduced to the market, heavily influencing the adoption of new technologies.[2] (3) The formal consent given by health authorities, such as the FDA, to market a new drug or pharmaceutical product.[3] (4) The process through which health authorities evaluate the safety and efficacy data, allowing atorvastatin to be marketed for patient use.[4] (5) Necessary permissions obtained for various stages of animal research to ensure compliance with legal and ethical standards.[5]
From: Journal of Ayurveda and Integrative Medicine
(1) The necessary governmental validation required before 'BhAVI-23' can be implemented as a supportive healthcare system during the pandemic.[6]
From: Ayushdhara journal
(1) Certifications or validations obtained to ensure that herbal products meet safety, efficacy, and quality standards for public health.[7]