STATEMENT OF INTENT ON COLLABORATION BETWEEN THE FOOD AND DRUG ADMINISTRATION OF THE UNITED STATES OF AMERICA AND FEDERAL SERVICE ON SURVEILLANCE IN HEALTH CARE AND SOCIAL DEVELOPMENT OF THE RUSSIAN FEDERATION
The U.S. Food and Drug Administration (FDA) located at: 10903 New Hampshire Ave., Silver Spring, MD 20903, USA and the Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (ROSZDRAVNADZOR) located at:
4 Slavyanskaya Square, building 1, Moscow, 109074 Russia. Hereinafter FDA and ROSZDRAVNADZOR are collectively referred to as the “Participants,” and each of the agencies is referred to as a “Participant.”
- Acknowledging the importance of drugs for saving lives, restoring health, treatment and prevention of diseases;
- Understanding that there is a need, in the interests of public health, to raise public awareness about drug quality and safety through distribution of information about drug quality and safety;
- Acknowledging the importance of long-term interaction to help ensure availability of high-quality and safe drugs to consumers, and to prevent the distribution of counterfeit and poor-quality or unsafe drugs;
- Sharing the common objective to improve the quality of drug products in the United States of America and the Russian Federation;
- Considering that the coordination of complementary actions of the Participants may promote the achievement of common objectives in the field of health care; and
- Addressing the objectives of raising public awareness of the importance of drug efficacy, safety, and manufacturing quality, of exploring areas of mutual interest, and of developing possible areas and procedures for mutually agreed cooperation;
The Participants express the following intentions:
1. In the framework of this Statement and taking into account available human and financial resources and all legal requirements, the Participants expect to cooperate in the following areas, including, but not limited to:
- Scientific meetings, symposia, seminars, and fora that may be organized both in the United States of America and the Russian Federation.
- Meetings of the Participants’ senior executives or their representatives to be held (in person or by teleconference) as needed to identify issues to be discussed and prospects for cooperation and strengthening and improving the bilateral relationship and transparency.
- Exchanges of staff and other experts, as well as materials as mutually agreed by the Participants.
- Promotion of regulatory harmonization based on best practices.
- Promotion of application of current best laboratory standards and modern methodological principals.
- Organization of other events and exchanges subject to prior approval by the Participants.
- Simplification of information exchange and emergency notification procedures to be followed in case of contamination or counterfeit, whether occasional or deliberate, of drug products and their ingredients.
- Collaboration and exchange of expertise on topics of mutual interest. These topics could include ensuring quality of clinical trials conduct and data by adherence to international standards of Good Clinical Practices (GCP).
2. The Participants intend to nominate, within not more than 60 (sixty) calendar days after signing of this Statement, a primary Point of Contact (POC) for each Participant, who will be responsible for routine and emergency communication between leaders of the Participants;, and for preparation of projects or proposals to the leadership for creation of working groups, elaboration of working plans, preparation of agendas and taking minutes of meetings.
3. Each Participant is expected to bear all its costs for activities under this Statement, unless the Participants agree otherwise and prepare a document that sets forth financial and technical responsibilities of each Participant. Specific activities should commence only after the said document is approved by both Participants.
4. This Statement of Intent does not constitute an international agreement and does not create rights and obligations provided for by international law.
5. Cooperation under this Statement of Intent commences as of its dates of signature by Participants. This Statement of Intent may be modified at any time by mutual written consent of the Participants. Either participant may cease cooperation under this Statement of Intent by giving written notice of no less than three (3) months to the other Participant.
This Statement of Intent was signed at Moscow, in duplicate, on this 27th day of May 2010, in the English and Russian languages.
ON BEHALF OF
THE UNITED STATES
FOOD AND DRUG ADMINISTRATION
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
ON BEHALF OF
THE FEDERAL SERVICE ON SURVEILLANCE IN HEALTH CARE AND SOCIAL
DEVELOPMENT OF THE RUSSIAN FEDERATION
Elena A. Telnova
Acting Director of Rozdravnadzor