The Gulf Central Committee for Drug Registration (GCC-DR)

GCC-DR structure, registration process and points to consider when choosing this route to registration

Gulf Central Committee for Drug Registration
The Gulf Central Committee for Drug Registration (GCC-DR) was formed in May 1999 with six Middle Eastern States – Saudi Arabia, Kuwait, Qatar, Bahrain, Oman and the United Arab Emirates; and in 2003 Yemen became the seventh member of the GCC-DR.  The aim of the GCC-DR is to work together to review/approve pharmaceutical companies and their drugs by means of a centralised registration procedure in order to provide the seven member states with safe and effective medicines with a reasonable price.  Included in the structure of the GCC-DR is a permanent Secretariat with responsibilities including the receiving/reviewing of registration files for completeness, 2 members nominated from each State regulatory authority (collectively called the “Steering committee”) with duties including company/product registration and guideline approval, a general director, an executive board, and at the highest level the Council of Ministers of Health (CMH).  The CMH consists of health ministers from each of the seven member States and overseas approval of all guidelines and policies adopted by the Steering committee.

The World of Biosimilars

monoclonal antibodies

monoclonal antibodies

Biopharmaceuticals constitute a significant proportion of medicinal products used for the treatment of several life-threatening and chronic diseases. Moreover, biopharmaceutical drugs are one of the fastest growing segments of the pharmaceutical industry. The biopharmaceutical market, presently estimated at approximately US$200 billion globally is further projected to reach approximately US$500 billion by 2020.

It is estimated that over 400 biopharmaceuticals are currently in clinical trials for over 200 diseases, some of which currently do not have treatments. However, the development and manufacture of biologic medicines is very costly, resulting in a high price tag for treatment involving biopharmaceuticals. Healthcare expenditure can be decreased by using cheaper biosimilars (also variously referred to as similar biological medicinal products, similar biotherapeutic products, follow-on biologics, subsequent entry biologics, similar biologics), which are similar versions of already registered biological medicines.

Certificates of Pharmaceutical Product (CPPs)

generic substitutionTo obtain global marketing approval for any pharmaceutical product (whether intended for animal/human use) one of the key documents required is a Certificate of Pharmaceutical Product (CPP), which has been recommended by the World Health Organisation (WHO).