Saturday, February 11, 2012

GMP inspections from Health Authorities of developing countries

María Inés Guaia, Argentina

Getting positive reports of GMP inspections of manufacturing facilities have always been a very important step in the process of registration of a new drug product in a country. Traditionally, developing countries would rely on GMP certificates issued by high-surveillance health authorities, such as those the members of the International Conference on Harmonisation, ICH: USA, Japan and European countries.

But, as economies in development start to be heavy targets for the pharmaceutical business, the landscape tends to change. Although Certificates of Pharmaceutical Product, documents that prove that a drug product is approved or marketed in a country, issued by developed countries are still widely required by regulatory agencies of the rest of the world, most of these agencies now started requiring further information and documentation from pharmaceutical companies to review and, in many cases, began inspecting manufacturing facilities themselves.

Such is the case of Turkey, which in 2010 issued a new regulation according to which GMP inspections by the Turkish Ministry of Health had to be performed and approved for all new imported pharmaceutical products. Other Arabic countries, as well Brazil, Mexico and Taiwan to mention a few, reserve the rights to inspect facilities, and sometimes create and update their own GMP guidelines, frequenlty based on those enforced by EMA or FDA or written by WHO.

Another trend in the international GMP matter, is that of collaboration and mutual recognition agreements among developing countries. This could mean, authorities of two or more countries carry out joint inspections, or groups of countries either recognize each other's GMP certificates or formalize unions with own power to conduct inspections, which results will be valid for all the participants. As examples we have Brazil, accepting GMP certificates issued by the rest of the MERCOSUR countries Argentina, Paraguay and Uruguay; in the middle East, the Cooperation Council for the Arab States of the Gulf, grouping Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and United Arab Emirates, through its GCC Council of Health Ministers, performs inspections and issues certificates, accepted by all the GCC members plus Yemen.

These changes and transitions could be not always smooth and inicially satisfying, but should be encouraged and supported by the international comunity because, positively, along with their population and GDP, developing countries are growing their involvement and responsibility on the quality of the drug products for use of their people

(About the author: My name is María Inés Guaia, and I am a 24-year-old, advanced Pharmacy student from Buenos Aires, Argentina. I am very interested in topics of public health, international health, neglected diseases, tropical medicine, regulatory affairs, intelectual property, etc)

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