DuBiotech finalizes regulatory framework

DuBiotech has partnered with the Research Triangle Institute International (RTI) to develop the park's comprehensive Codes of Practice (COPs) based on international best practices covering all activities related to Clinical Research and Clinical Trials, Manufacturing and Environment, Health and Safety. The COPs developed are in-line with those of the US Food and Drug Administration (FDA), World Health Organization (WHO), Occupational Safety and Health Administration (OSHA), European Agency for the Evaluation of Medicinal Products (EMEA), and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Dr Abdulqader Alkhayat, DuBiotech's Executive Director, said: "We are proud to announce the completion of the regulatory framework, which will harness Biotechnology's potential to improve health, enhance quality of life and promote a sustainable economy. In developing this critical document, we found an ideal partner in RTI."

Al Khayat added: "In developing this regulatory framework, we have taken into consideration the Shar'iah law, and by completing it we have taken a crucial step towards providing a secure environment for research and innovation."

Recognizing Research and Development (R&D) as a core component of the park's activities, DuBiotech and RTI have meticulously created COPs governing all aspects of R&D. The research component of the COPs outlines the research governance structure, ethical and environmental compliance requirements, good laboratory practices, Institutional Review Committee (IRB) responsibilities, investigator's obligations and informed consent procedures thus assuring governance and compliance throughout the R&D value chain.

The regulatory framework also includes COPs governing Manufacturing activities in the park. Good Manufacturing Practices (GMP) as well as Good Laboratory Practices (GLP) are described focusing on pharmaceutical, bio-pharmaceutical and sterile medicinal products manufacturing. Compliance and Accreditation requirements of Cord Blood Banks are also included in DuBiotech's regulatory framework.

DuBiotech's regulatory framework also contains COPs on Environment Health and Safety addressing all the potential risk factors related to the park's core activities and specifically dealing with prevention and control of integrated pollution, handling of hazardous chemical and biological agents, health and safety at work, as well as waste management.

Announced in February 2005, the Dubai Biotechnology and Research Park (DuBiotech) is a cluster dedicated to the Biotechnology and Pharmaceutical industry, set within a free zone infrastructure. DuBiotech aims to set up a biotechnology industry cluster with the appropriate infrastructure, facilities and service for incubators, R&D labs, biotech-related educational institutions, suppliers, biotech and pharmaceutical manufacturing companies.

The Foundation for Research and Innovation (FRI), which will be the main arm focusing on government funded R&D, will initially focus on research related to genetics, plant biotechnology encompassing food and agricultural biotech, environmental biotech and equine-related biotechnology, drug discovery, stem cell research, infectious diseases and forensic research.