Showing posts with label Good Manufacturing Practices. Show all posts
Showing posts with label Good Manufacturing Practices. Show all posts

Friday, December 7, 2012

Be welcome, Innovation.



From Europe 2020 to Strategy for American Innovation. From Brasil Maior to Industrial R&D Promotion Programme. All the governmental programs mentioned above try to create conditions and stimulate a national foundation for innovative industries in the European Union, United States, Brazil and India. Innovation seems to be the answer for national development and sustainable economic growth.

Seeking to increase a better understanding of innovative approaches and measurement, the Organization for Economic Co-operation and Development (OECD) developed the Oslo Manual[1], which provides guidelines for collecting and interpreting innovation in an internationally comparable manner. Even with limitations, every new edition of the Oslo Manual represents a step forward to the understanding of the innovation process.

Using the meanings and criteria of the Oslo Manual, the UNESCO Institute of Statistics presented the 2011 UIS Pilot Data Collection of Innovation Statistics[2]. Comparing 12 countries from different regions and at different levels of development, it seeks to show the different stages of innovation process around the world, taking especial attention to developing countries.

As one shall conclude, innovation is a concern for both developed and developing countries. With different levels of innovation process, each one acts according to its needs and goals. Catching up is the main target for developing countries in order to not fall behind in international trade and development. As for developed countries, they have reached a stage of progress that the only way of not becoming outdated is with
“(…)Investments, technology development, innovation and good management practices(…)”
President Dilma’s speech, April 3rd, 2012









[1] For further information about the Oslo Manual, access http://epp.eurostat.ec.europa.eu/cache/ITY_PUBLIC/OSLO/EN/OSLO-EN.PDF
[2] For further information about the 2011 UIS Pilot Data Collection of Innovation Statistics, access http://www.uis.unesco.org/ScienceTechnology/Documents/Innovation-statistics-en%20(2).pdf

Wednesday, December 7, 2011

Brazil and the Global Harmonization Task Force (GHTF)

According to the FDA, the Global Harmonization Task Force (GHTF) fosters international harmonization in the regulation of medical devices. Regulatory and industry authorities from Europe, Asia-Pacific and North America collaborate to encourage the harmonization of regulatory practices to ensure the safety, effectiveness and quality of medical devices.

The GHTF was founded in 1992 and its main purpose is to standardize medical device regulations around the world by the exchange of information. Some of the benefits of the standardization are the convergence in regulatory practices related to ensuring safety and facilitating international trade.

On November 11, Brazil, Argentina, Colombia and Cuba’s regulatory agencies agreed to work in cooperation, through the inspection of manufacturers of medical devices in each country. The Brazilian regulatory agency (ANVISA) requires a Good Manufacturing Practices (GMP) certification from medical devices manufacturers, and the inspection is conducted by the agency itself. From January of 2013 the GMP certification issued by the Argentinean, Colombian, and Cuban agencies will be accepted in Brazil as well, which means more efficiency in the certification process.