CDSCO-UKHMRA MoU on medical products
Post-Brexit, a Memorandum of Understanding (MoU) aims to enhance the scope of cooperation and opportunities for India in Telecommunications and Information and Communication Technologies (ICTs) and medical Product Regulation with the United Kingdom.
The Union Cabinet approved on 4 Nov 2020 the MoU for ICTs along with another for medical Product Regulation in the United Kingdom.
The Parties have identified the following areas of common interest for cooperation in:
Telecommunications/ICT policy and regulation;
Spectrum Management;
Telecommunication connectivity including mobile roaming;
Telecommunications/ICT technical standardizations and testing & certification;
Wireless Communications;
Technological development in Telecommunications/ICT including 5G, Internet of Things/Machine to Machine, Cloud Computing, Big Data etc;
Security of Telecommunication Infrastructure, Security in the provision and use of telecommunication services;
Building capacity in high technology areas and exchange of expertise wherever possible;
Collaboration and Sharing of information on Research & Development on emerging technologies and innovation where appropriate;
Exploring opportunities for joint work in signatory countries and third countries on Telecommunications/ICT;
Facilitating Trade, investment and technology activities through Telecommunication/ICT industry delegations and visits, events, exhibitions etc. as mutually agreed; and
Other forms of cooperation in Telecommunications/ICT as mutually agreed upon by the Parties, falling with the scope of MoU.
The second MoU will help in establishing a framework for fruitful cooperation and exchange of information between the Central Drugs Standard Control Organization (CDSCO) and the United Kingdom Medicines and Healthcare Products Regulatory Agency (UKMHRA) relating to medical products regulation in line with their international responsibilities.
The main areas of cooperation between the two Regulatory Authorities include the following:
Exchange of safety information, including Pharmacovigilance where there is a particular safety concern related to the other party. This includes safety concerns relating to medicines and medical devices;
Participation in scientific and practical conferences, symposia, seminars and fora organized by India and the United Kingdom;
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);
Capacity building in mutually agreed areas;
Promote an understanding between the Parties of each other’s regulatory framework, requirements and processes; and to facilitate future regulatory strengthening initiatives for both Parties;
Exchange of information on laws and regulations regarding medicines and medical devices;
Information exchange to support efforts to control unlicensed exports and imports;
Coordination at the international fora.
The MoU would facilitate a better understanding of the regulatory aspects between the two sides and could help in increased cooperation in the field of medical products regulation and better coordination in international fora, said the Cabinet in giving the approval. #ICTs #telecommuinications #technologies #medical #WHO #health #regulations /fiinews.com
