US and Russia co-operate to improve medicine quality

The US has signed a Memorandum of Understanding (MoU) with the Russian Federation formalising a common goal to improve the quality of medicines in their respective countries.

The Russian Ministry of Healthcare and Social Development and the US Pharmacopeial Convention (USP) are responsible for the official pharmacopeias of their respective nations. These contain written standards (monographs) designating the identity, strength, quality and purity of medicines and their ingredients. Such standards are one of the key safety nets securing the drug supply and protecting patients from poor quality medicines. Other written standards, as well as reference materials, the pure chemicals to which pharmaceutical manufacturers compare their products and ingredients, support these monographs.

‘Partnerships and strong alliances between nations are critical as pharmaceuticals become an increasingly globalised industry,’ said Roger Williams, chief executive of USP.

‘In particular, as we all collectively grapple with the risks posed by substandard and counterfeit medicines, the importance of information sharing, joint scientific work, modern standards and coordinated responses becomes even more pronounced.’ V I Skvortsova, deputy minister of healthcare and social development for Russia, said: ‘Today’s agreement represents an important step in a natural partnership between the Ministry and USP, given our common goal to improve and ensure the quality of medicines relied upon by patients as an integral component of healthcare.’

The two countries will co-operate in a number of areas related to drug quality, including:

• Facilitating exchange of information and taking action in cases of emergency arising from accidental contamination or intentional adulteration of medicines and their ingredients
• Exchanging scientific or other staff as part of potential scientist exchange and executive training programmes
• Conducting annual scientific meetings, workshops, seminars and forums as needed in the Russian Federation or the US
• Promoting harmonisation of major pharmacopeial requirements
• Promoting use of modern laboratory standards and application of modern measurement principles, including those arising from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Other areas covered in the MoU include potential third-party certification programmes for pharmaceutical ingredients, education and training programmes covering topics such as quality control and Good Laboratory Practices (GLP), and reference material development and availability.