FDA notes “continued growth” of Orbis collaborative review program, adds EMA as observer
There has been “continued growth” in the number of applications submitted to Project Orbis, and the European Medicines Agency (EMA) has announced plans to join the multicountry review consortium as an observer, R. Angelo de Claro, the division director for FDA’s Office of Oncologic Diseases (OOD) at the Center for Drug Evaluation and Research (CDER).De Claro offered an update on Project Orbis during the Pharmaceutical Quality Symposium sponsored by the Small Business and Industry Assistance (SBIA) program at the FDA Center for Drug Evaluation and Research on 1 November.
FDA launched Project Orbis in September 2019 to facilitate concurrent submission and review of oncology drugs with regulators from Australia’s Therapeutic Goods Administration (TGA) and Health Canada (RELATED: FDA Collaborates With Health Canada, Australia to Approve New Cancer Drugs, Regulatory Focus 17 September 2019). The program aims to provide patients globally with equal access to new cancer medicines by allowing drug manufacturers to register these treatments in multiple countries.
The program has since expanded to include Singapore’s Health Sciences Authority (HSA), Switzerland’s Swissmedic, Brazil’s Agencia Nacional de Vigilancia Sanitaria (ANVISA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), and the Israel Ministry of Health (MOH).
De Claro said that this year, EMA has expressed interest in participating as an observer. “We look forward to working closely with EMA to see how to integrate EMA into our project focus,” he added.
De Claro noted that the program has grown continually since its inception. A total of 369 applications have been submitted to the program since its inception, representing a significant jump from the 27 submitted in 2020. He noted that “we are very happy with these results.”
Out of the total applications, 33% are for new molecular entities, and the remainder are either new indications or new dosage forms for pediatric populations.
He said that an average of three countries participated in each review. Project Orbis comprises 40% of the FDA’s oncology division workload.
One of the program’s benefits is that it enables FDA’s oncology review staff to share their expertise with other regulators. The agency has a full-time staff of 280 people working in the oncology area as physicians, statisticians or pharmacologists. They are organized into 18 disease-specific areas.
Marketing applications accepted into the program are submitted electronically to each authority using the Common Technical Document (CTD) format. All documents must be in English.
De Claro noted some logistical challenges posed by the simultaneous review of applications by multiple authorities, including coordinating reviews across multiple time zones, a learning curve associated with managing these applications, and translation challenges.
CDER SBIA meeting
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