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CDSCO, MHRA to sign MoU on regulation of medicines, medical devices

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Exchange of safety information related to medicines and medical devices, and supporting efforts to control unlicensed exports and imports are some of the areas to be included in the MoU

The Union Cabinet, chaired by Prime Minister Narendra Modi, has approved the signing of a Memorandum of Understanding (MoU) between India’s Central Drugs Standard Control Organisation (CDSCO) and the United Kingdom Medicines and Healthcare Products Regulatory Agency (UK MHRA) to establish a framework for cooperation and exchange of information related to regulation of medicines and medical devices.

The main areas of cooperation between the two authorities include the following:

  1. Exchange of safety information, including pharmacovigilance where there is a particular safety concerns. This includes safety concerns relating to medicines and medical devices
  2. Participation in scientific and practical conferences, symposia, seminars and fora organised by India and the UK
  3. Exchange of information and cooperation on Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Good Pharmacovigilance Practices (GPvP)
  4. Capacity building in mutually agreed areas
  5. Promote an understanding between the two regulatory frameworks, requirements and processes; and to facilitate future regulatory strengthening initiatives for both sides
  6. Exchange of information on laws and regulations regarding medicines and medical devices
  7. Information exchange to support efforts to control unlicensed exports and imports
  8. Coordination at international fora
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