Biotechnological products are medicines produced from animal cell substrates and microbial cultures. Constitutes proteins obtained by the recombinant DNA technique expressed in animal tissues or in microbial life forms, including products obtained through the monoclonal antibody technique 1. The World Health Organization also uses biotherapeutic products name to refer to biotechnological products.
The development of these products has grown extremely rapidly due to its importance in the prevention, diagnosis, control, and treatment of diseases. Its regulation faces new challenges in comparison with the regulation of conventional drugs obtained by chemical synthesis.
In January 2010, the Pan American Network on Drug Regulatory Harmonization Steering Committee (PANDRH) decided to establish a new working group to deal with the specificities of biotechnological products regulation. The decision is included at the minute.
In June 2010, this working group (GT BIO) met for the first time for: designate the main and alternate coordinator, the short and medium term objectives, and the establishment of communication mechanisms. This and other information appear in this Web site.
Promote the development of the regulation of biotechnological products in the countries of the Americas Region, and to generate more effective and harmonized mechanisms for the regulation of this category of medicines.
1. Compile a list of all regulations related to biotechnological products in place at country level and make them available at the Regional level.
2. Establish a glossary of terms to help understand the situation in Member States and to facilitate the further development of related documents.
3. Promote the exchange of information among National Regulatory Authorities of the Region.
4. Identify Regional documents and guidelines for development in the short and medium term and elaborate them as appropriate.
5. Identify other issues related to the regulation of biotechnological products that may require special treatment and establish working plans to address them.
6. Develop tools and training programmes to strength capacity building among the National Regulatory Authorities of Members States in relation to the regulatory oversight of biotechnological products and related matters.