![]() The Participants intend to explore mechanisms for regular meetings and other types of engagements to develop plans for exchanging information, capacity building, and strengthening regulatory cooperation. The Participants, in accordance with their respective laws and regulations, intend to collaborate as appropriate to implement this Memorandum of Understanding to facilitate effective exchange of information, develop and strengthen cooperative efforts and initiatives, and coordinate, when appropriate and effective, with other regulators, including state and territorial entities, multilateral organizations, and other key stakeholders relevant to medical product regulation, provided that such exchange of information and cooperative efforts are to be routed through CDSCO or the USFDA, as appropriate. ![]() Maintaining long-term global efforts to help ensure timely and secure availability of high quality, safe, and effective medical products to consumers, and to prevent the distribution of sub-standard or unsafe medical products.Continuing to strengthen and harmonize regulations in keeping with international standards and,.Furthering medical product innovations and development to increase access to medical products for saving lives, restoring health, and treating and preventing diseases, including but not limited to considerations for fostering medical product innovation to address issues of global concern and emerging areas of public health.Determining the clinical safety and effectiveness of medical products through well-designed, scientifically robust, and ethically conducted clinical trials with systems in place to assure the adequate oversight of human clinical trials.Ensuring the safety, effectiveness, manufacturing quality, and security of human and veterinary medicines, vaccines, and other biological products, medical devices and diagnostics.The Participants acknowledge they share a common interest in strengthening bilateral cooperation in regulatory systems to promote and protect public health through supporting collaborative partnerships in the following areas: ![]() The Memorandum of Understanding covers medical products that both Participants have authority to regulate. This Memorandum of Understanding is intended to develop and strengthen opportunities for cooperative engagement in regulatory, scientific, and technical matters and public health protection that are related to medical products the Participants regulate. The Participants intend to build on the areas outlined in the Statement of Intent between the Food and Drug Administration of the United States of America and the Ministry of Health and Family Welfare of the Republic of India on Co-Operation in the Field of Medical Products, signed on February 10, 2014. The Participants share a mutual high regard for the crucial role that their respective regulatory systems perform to ensure medical products that each Participant regulates are safe and effective. The Food and Drug Administration (USFDA), Department of Health and Human Services of the Government of the United States of America, and the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services (DGHS), Ministry of Health and Family Welfare (MOHFW) of the Government of the Republic of India, hereinafter collectively referred to as the “Participants,” and individually referred to as “Participant,” recognize the importance of timely and effective collaboration, communication, and information exchange in the promotion and protection of public health.
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