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It is very much in the vision of this programme to see strong, resourceful and effective NRAs in the Member States

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In the Name of God, the Compassionate, the Merciful

Address by

DR HUSSEIN A. GEZAIRY REGIONAL DIRECTOR

WHO EASTERN MEDITERRANEAN REGION to the

INRODUCTORY MEETING ON PREQUALIFICATION PROGRAMME ON MEDICINES

Cairo, Egypt, 6–7 June 2007

Distinguished Participants, Dear Colleagues, Ladies and Gentlemen,

It is my great pleasure to be with all of you in this important meeting. I welcome you all – the representatives of the national manufacturers associations, respected regulators from the same countries, colleagues from WHO headquarters in Geneva and especially the invited experts in this meeting. As you can see this is a gathering of those who produce medicines and those who make sure that what is being produced is of acceptable quality and hence is safe to use.

Ladies and Gentlemen,

This meeting is unique because it focuses on a particular programme of WHO, the WHO Programme on Prequalification of Medicines, which at present is limited to medicines for tuberculosis, malaria and HIV/AIDS. Through this introductory meeting we are initiating a process through which we want to spread information about this programme to the potential manufacturers of these medicines in the Region and how they can benefit from it. I must emphasize however that this remains a voluntary programme and it is up to the manufacturers whether they want to engage with it and benefit from it. At the same time we have invited the senior regulators from the same countries that the manufacturers are from, because we believe that no global system of quality control of medicines can replace the national regulatory system,

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nor does this WHO Prequalification Programme on Medicines aim to replace the role of the national regulatory authorities. On the contrary, the NRAs have their own legitimate reasons and ways to benefit from this programme. It is very much in the vision of this programme to see strong, resourceful and effective NRAs in the Member States. I cannot emphasize more that development of national regulatory institutions, infrastructure and national expertise in regulatory affairs is our major priority and will remain so.

Ladies and Gentlemen,

The WHO constitution mandates us to “develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products”. This is one of the important functions of WHO, which was established “to promote and protect the health of all peoples”. It is in fulfilling this function and purpose that WHO has been involved in the development and dissemination of norms and standards for quality medicines among others. I cannot list the wealth of work, knowledge and products that we have produced in the last 60 years. This impressive body of work ranges from the production of the International Pharmaecopia to development of current GMP, GCP and GLP standards. Not only do we produce these global norms and standards for quality health technologies, including pharmaceuticals, in collaboration with global experts from our 193 Member States, but we also actively disseminate these standards to all the Member States and contribute in capacity-building and training in the implementation of these standards in order to achieve assured quality of health products.

It is important to mention that improving the quality of medicines, ensuring their safety and strengthening regulation is part of the comprehensive WHO Medicines Strategy 2004–2007. I encourage all of you to go through this important document, which captures our vision and work in the crucial area of medicines.

Ladies and Gentlemen,

In the past few years, as new players, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, have become involved in the supply of medicines to people in developing countries, a practical issue has become apparent, that is also a paradox. They found that while they could get better prices from the generic manufacturers in the developing countries, at the same time

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they were not so sure about their quality, and more importantly and unfortunately, they were not sure of the capacity of the NRAs in some developing countries to ensure the quality of these products. In order not to lose out on better prices they inevitably came back to WHO with the request to assist in ensuring the quality of these medicines. Realizing that this is neither our role nor do we want to replace the role of the NRAs, we nevertheless saw an important window of opportunity: first to answer the global call for assistance; second to raise the image of the many manufacturers in developing countries who are well known nationally and sometimes regionally as producers of quality medicines but are less known in the international market; and finally to more strongly engage and involve the NRAs and build their capacity and experience in dossier evaluations, inspections of the manufacturers and testing. After all, our workforce in the Prequalification Programme is ultimately provided by the NRAs of the Member States.

The WHO Prequalification Programme was started in 2001 and in the years since then more than 150 medicines have been given the status of prequalified medicines by the programme as a result of very rigorous evaluation. Nevertheless, it has astonished us that hardly any product has been prequalified under the programme in the Eastern Mediterranean Region. This is despite the fact that we have some world class manufacturers of these medicines. Either they did not know about this programme or they were not interested. Our initial contacts revealed that the former was the case. This led our team here in the Regional Office and our colleagues in headquarters to

start proactively to introduce the programme in the Region.

Ladies and Gentlemen,

This is a first meeting of this programme in WHO Eastern Mediterranean Region. This is just a beginning. The last session of this meeting has been deliberately kept for planning for the future. I hope that you will provide your input in this planning process also. On the side lines, an important meeting will also take place among regulators in order to activate their regional network.

I hope that you have a successful meeting and that in the coming months we will hear good news about prequalified products from manufacturers in the Region. I wish you a pleasant stay in this historical city of Cairo.

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