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STRENGTHENING NATIONAL REGULATORY AUTHORITIES BUILDING CAPACITY THROUGH THE REVIEW OF NATIONAL REGULATORY SYSTEMS National Regulatory Authorities (NRAs) are responsible for the regulation and control of medical products such as medicines, vaccines, blood products and medical devices. They contribute to promoting and protecting public health by ensuring that: • medicines are of the required quality, safety and efficacy, • health professionals and patients have the necessary information to enable them to use medicines rationally, • medicines are appropriately manufactured, stored, distributed and dispensed, • illegal manufacturing and trade are detected and adequately sanctioned, • promotion and adverting is fair, balanced and aimed at rational drug use, • access to medicines is not hindered by unjustified regulatory work. Intensification of international commerce and increasing technological complexity of manufacturing and product specifications have created additional challenges for national regulatory authorities and manufacturers, particularly to those of developing countries. This requires that national regulatory capacity is regularly reviewed, areas of weakness are identified and appropriate, necessary measures are taken. Reviews are conducted using a standardized data collection tool . OBJECTIVE OF REVIEWS OF NATIONAL REGULATORY SYSTEMS Reviews aim at strengthening national regulatory and control capacity through an assessment of the situation, the identification of specific needs, and the provision of appropriate technical support and training. TERMS OF REFERENCE FOR REVIEW TEAMS • • • Review the existing legal framework, regulations and control activities with regard to medicines, vaccines and medical devices in order to assess the national regulatory capacity against a set of predefined parameters; In collaboration with national officials, identify gaps and develop strategies to address these gaps; Identify specific areas and activities for WHO’s technical input. TENTATIVE PROGRAMME OF A REVIEW VISIT The duration of a review visit is in general three to five days divided into three phases. It can be longer when field visits are necessary. First day Introduction and beginning of review phase Review phase (up to day 3 or 4) Last day: debriefing and submission of summary report - Meeting with staff of the NRA to introduce team, objectives and expected outcome - Decide review work plan - Start review Collection of information based on standardised data collection tool and list of materials to be submitted - Presentation and discussion of findings with relevant technical staff, senior management and WR - Amendments of the findings to reflect discussions - Copy of summary report including Institutional Development Plan provided by review team REVIEW TEAM The review team includes WHO staff, experts, and at least one national officer designated as focal point by the country hosting the review visit. A member of the team will act as team leader and present the summary report on behalf of WHO. Each team member will sign a confidentiality agreement (annex 1) and a declaration (annex 2) on conflicts of interest before recruitment for a review visit. INSTITUTIONS AND PERSONS TO BE MET The team will visit all institutions involved in the regulation and control of drugs and vaccines and, where applicable, medical devices and blood products. In certain circumstances, it may be appropriate to meet with senior officials and technical staff involved in procurement, reception, storage and distribution of drugs and vaccines. These meetings aim at hearing their views and gather information on how the regulatory processes affect their work. Where appropriate, visits to local manufacturers will be organized focusing on the mechanisms of communication and control established between manufacturers and national regulatory authorities. A visit of selected manufacturing facilities could be organized and meetings set up to discuss problems encountered by manufacturers in the implementation of GMP. MATERIALS TO BE PREPARED IN ADVANCE BY NATIONAL COUNTERPARTS AND REVIEWED BY THE TEAM Availability of the documentation listed here below is crucial to the success of the assessment visit and can even shorten it. It is therefore extremely important that such materials are collected before the visit takes place and made available to the review team in electronic format or hard copies. Put a date in the right-hand column if the documentation has already been provided to WHO on the occasion of earlier visits and there is no more recent update. DOCUMENTATION Legal basis for regulation of drugs and vaccines, and, where applicable, medical devices and blood products Structures and operational aspects of drug and vaccine (and, where applicable, medical devices and blood products) regulation at the different levels in the country Comprehensive list of institutions, departments, and focal points involved in drug and vaccine (and, where applicable, medical devices and blood products) regulation and procurement; if available provide an updated organigramme dated and signed List of drugs and vaccines (and, where applicable, medical devices and blood products) approved for marketing and their sources Number of doses of vaccines procured and administered in the last two years and forecast for the coming year Detailed list of vaccines (and their sources) used in national immunization programmes National immunizations schedule List of local drug and vaccine (and, where applicable, medical devices and blood products) manufacturers and list of items produced List of drug and vaccines (and, where applicable, medical devices and blood products) donations received over the last two years Drug and or Vaccine donation policy Documentation on any collaborative activity or mutual recognition agreements with other national regulatory authorities Annual Reports or descriptive materials on the work of the national regulatory authority(ies), the national inspectorate(s), the national quality control laboratory/ies, the national adverse reaction/events monitoring system Recent reports/studies on the different areas of work of the national regulatory authorities (e.g. product licensing activities, inspectorate, quality control activities) List of staff involved in regulatory system by regulatory functions Budget allocated for regulatory activities including training Training plan for regulatory staff including training provided and not completed or pending Provided EXPECTED OUTCOME At the end of the visit, a presentation of the findings will be discussed first with national officials in order to agree on the findings. Then a final presentation will be made to all senior staff. A summary report will be provided outlining the findings and the outcome of the discussions held at the end of the visit. An institutional development plan (IDP) will also be part of the report. The IDP, which will reflect the discussions held with national officials, will include an outline of possible technical support and training activities for all areas where weaknesses and needs have been identified. WHO will also propose that national experts, whenever identified during the visit, will be recruited to participate in future review visits aimed at assisting NRAs of other countries. CONFIDENTIALITY All materials collected during the visit and the report will be treated as strictly confidential. They will be available only to concerned WHO staff. The materials and copy of the report will be stored at WHO and accessible only to authorised WHO staff. WHO will not provide copy of the report, the materials collected, or any oral or written information related to the review to any persons or institutions without the written authorisation of the country that has hosted the visit. ANNEX 1 CONFIDENTIALITY UNDERTAKING BY TEAM MEMBERS PARTICIPATING IN COUNTRY VISITS FOR THE REVIEWS OF THE NATIONAL REGULATORY SYSTEM In the course of country visits as an expert adviser to WHO you will have access to certain information that belongs to the institutions that you will visit or to WHO or entities collaborating with WHO. You undertake to treat such information (hereinafter referred to as “the Information”) as confidential and proprietary to the aforesaid parties. In this connection, you agree: 1. not to use the Information for any other purpose than those requested by WHO; and 2. not to disclose or provide the Information to any person who is not bound by similar obligations of confidentiality and non-use as contained in this document. However, you will not be bound by any obligations of confidentiality and non-use to the extent that you are clearly able to demonstrate that any part of the Information: 1. was known to you prior to any disclosure by or on behalf of the institutions visited or WHO; or 2. was in the public domain at the time of disclosure by or on behalf of the institutions visited or WHO; or 3. becomes part of the public domain through no fault of your own. You also undertake not to communicate your findings and/or those of the team of experts in which you will participate, as well as any resulting recommendations and/or decisions to any third party, except if explicitly requested in writing by WHO. You confirm that the information disclosed by you in the Declaration of Interest is correct and that no situation of real, potential or apparent conflict of interest is known to you. You undertake to promptly advise WHO of any change in the above circumstances, including if an issue arises during the course of your work for WHO. I hereby accept and agree with the conditions and provisions contained in this document. Signed _________________________________________ Name (typewritten) _______________________________ Institute ________________________________________ Place ________________ Date _____________________ ANNEX 2 DECLARATION OF NO CONFLICTING INTERESTS BY TEAM MEMBERS PARTICIPATING IN COUNTRY VISITS FOR THE REVIEWS OF THE NATIONAL REGULATORY SYSTEM In the course of country visits as an expert adviser to WHO you will have access to certain information that belongs to the institutions that you will visit or to WHO or entities collaborating with WHO. You undertake to treat such information (hereinafter referred to as “the Information”) as confidential and proprietary to the aforesaid parties. In this connection, you declare that: - you will discharge your functions exclusively as adviser to WHO; - no situation of real, potential or apparent conflict of interest is known to you, including that you have no financial or other interest in, and/or other relationship with, a party, which: - may have a vested commercial interest in obtaining access to any confidential information obtained in the course of the review visit, and/or - may have a vested interest in the outcome of the of the review visit including, but not limited to, parties such as manufacturers of medicines or vaccines. You undertake to promptly advise WHO of any change in the above circumstances, including if an issue arises during the course of your work for WHO. I hereby accept and agree with the conditions and provisions contained in this document. Signed _________________________________________ Name (typewritten) _______________________________ Institute ________________________________________ Place ________________ Date _____________________